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Miscellaneous drugs and agents
N.H. Choulis
51
Miscellaneous drugs and agents
Aminohydroxypropylidenebisphosphonate (APD) Two middle-aged women with stapedial otosclerosis and sensorineural hearing loss were treated with APD. There was no effect on the Schwartze sign either during or after therapy. There were no changes in audiometry during the first year, but a few weeks after this, both patients complained of sudden deterioration of their pre-existing hearing losses in both ears, with an alteration of tinnitus. One patient became totally bilaterally deaf, while the other retained minimal auditory function in the low frequencies (lCr). It is recommended that sensorineural deafness in selected patients with otosclerosis should be treated with sodium fluoride. Also, patients with Paget's disease treated with A P D must be closely monitored and the drug should be withdrawn if hearing deterioration is found. In another study in which A P D was used intravenously for the treatment of hypercalcemia in malignancies in 104 patients, 13% developed transient fever (2r
On occasions he also ingested other aspartamecontaining products. After discontinuation of aspartame-containing products all the nodules resolved within 12 days. The mechanism by which aspartame induces panniculitis is uncertain, but it may represent a hypersensitivity reaction to aspartame or one of its breakdown products (4 r, 5r). Finally, there has been a report of a 64-yearold man who complained of moderate frontal headache and slight depression on 2 occasions the day after taking aspartame, which was thereafter avoided (6r). On resuming aspartame a few years later he developed unusual daytime drowsiness, sleeping for up to 18 hours a day, followed by frontal non-throbbing headache, shaking chills, lethargy, miM confusion, and myalgia. The symptoms began to abate the day after he stopped taking aspartame. Calcium (SEDA-15, 532)
The question of whether a high calcium intake might increase the risk of nephrolithiasis has been discussed (7r). It was concluded that in patients who are at risk of developing Aspartame (SED-1, 913; SED-11, 1038; SEDA- nephrolithiasis or even in patients with a 8, 450; SEDA-IO, 437; SEDA-11, 432) positive history of nephrolithiasis, calcium can be administered for the treatment of osteopoThere are previous reports that aspartame rosis, provided that these patients are carefully can cause urticaria, angioedema, and granulo- monitored (8c). Concomitant therapy with matus septal panniculitis. There is now a report thiazides and dietary counselling can reduce that it can also induce lobular panniculitis (3c). the risk of nephrolithiasis associated with calThis happened in a 57-year-old diabetic cium. white man who developed several tender subA case of cutaneous calcium deposition, has cutaneous nodules on his back and arms. He been reported after extravasation of intravehad been taking 6-7 packs of aspartame as a nously infused 10% calcium gluconate, used for sugar substitute (35 mg per pack) and 3 6 4 8 the treatment of hypocalcemic tetany in a oz of aspartame-containing soft drinks per day. 1-month-old neonate (9c). After extravasation of the infused solution, marked swelling and erythema rapidly developed over the right 9 1994 Elsevier Science B.V. All rights reserved lateral malleolus. Histopathological examinaSide Effects of Drugs Annual 17 J.K. Aronson and C.J. van Boxtel, eds. tion of a nodule taken from the scalp showed 551
552 amorphous masses throughout the dermis and around the vein, identified as calcium with von Kossa's stain. Of 91 hyperphosphatemic dialysis patients taking calcium edetate 16 developed mild transient hypercalcemia (10CR). Oral administration of a calcium chloride-containing product caused minor to severe damage to the mucosa of the upper gastro-intestinal tract (llC). The gel solution of the drug was highly caustic, while the oil emulsion appeared to be relatively safe.
Collagen (SED-IO, 909; SED-11, 1035; SEDA9, 431; SEDA-IO, 432,- SEDA-13, 474) The incidence, clinical presentation, pathophysiology, and possible treatment of 2 rare but clinically important complications of tissue augmentation with Zyderm and Zyplast collagen implants have been described (12r). Abscesses as a manifestation of hypersensitivity to bovine collagen occur rarely (4 in 10 000 cases) and may persist for weeks. Localized tissue necrosis also occurs rarely (9 in 10 000 cases) after implantation and is probably the result of local vascular interruption and not a hypersensitivity reaction. The incidence varies greatly between the anatomic sites of implantation, but more than half of the cases involve the glabellar region, because of its unique vascular distribution. Lipsky (13 c) gave submucosal injections of bovine collagen to 1 boy, 41 girls, and 9 women. One child in whom pretreatment collagen testing had been negative developed anaphylactic shock, which was controlled by the administration of adrenergic agents and corticosteroids. In another girl an allergic rash appeared after collagen injection.
Dextran-70 (SEDA-16, 406; see also Chapter 36) Dextran-70 is a high molecular weight dextran, widely used as a distending medium for hysteroscopy. The use of large volumes of dextran during this procedure has been associated with adverse effects, including adult respiratory distress syndrome, pulmonary edema, bleeding coagulopathy and anaphylactic reactions (14 r, 15r). Detailed clinical observations in 3 patients with severe anaphylactic reactions
Chapter 51 N.H. Choulis after hysteroscopy made the diagnosis of dextran-induced anaphylactic reactions quite certain (16c). In all the patients the reaction occurred about 10 minutes after exposure to dextran. Presumably this is the period of time required for absorption from the uterine circulation.
Dipyridamole (SEDA-15, 533; SEDA-16, 412, see also Chapter 37) Dipyridamole, a potent coronary arteriolar vasolidator, is used with 201 thallium imaging for the detection of coronary artery disease. However, about two-thirds of patients experienced some adverse effects, e.g. nausea, facial flushing, headache, after dipyridamole infusion and some required nitrates for angina (17R). In another study, it has been reported that 13 of 16 patients developed chest pain, 1 had prolonged ischemia, and in 3 cases there was hypotension associated in 1 case with sinus bradycardia (18CR). Casanova et al. (19c) detected 1 case of ischemic ventricular dysfunction.
Exogenous gangliosides Exogenous gangliosides offer partial protection in experimental allergic neuritis. However, Guillain-Barr6 syndrome has been observed during ganglioside treatment. A case has been reported of chronic inflammatory polyradiculoneuropathy during ganglioside therapy (20c). A 58-year-old man with signs of vertebral spondylosis, was treated with a ganglioside mixture (100 mg daily intramuscularly). After 10 days he complained of tingling sensations in all limbs and some days later of weakness. He had intense sweating, a flaccid distal tetraparesis, mild sensory loss, and hyporeflexia with ankle areflexia. Electrophysiology showed a prevalent motor neuropathy with conduction block and delay or absence of F responses in all limbs. Cerebrospinal fluid (CSF) protein content was high (0.92 g/l) with oligoclonal bands and a normal cell count. Antibody investigation showed IgG to among others GM1 in both serum and CSF. Serum antiGM1 antibody titer was very high: 1:1280 (normal value less than 1:20). The patient was treated with intravenous human immunoglobulin with benefit.
Miscellaneous drugs and agents Chapter 51 The chronological relation between ganglioside administration and the onset of symptoms as well as high anti-GM1 serum antibodies justify concerns about a possible trigger action of exogenous gangliosides in this immune neuropathy.
Fibrin glue Fibrin glue is a physiological epoxy glue used in a variety of clinical situations including bleeding, following organ injury (21c), cardiac surgery (22c), and dural defects (2Y). Two cases of severe hypotension after the use of fibrin glue for hemostasis in hepatic injuries have been reported (24c). A 36-year-old black man was brought to the hospital emergency department after sustaining a gunshot wound to the left lower chest. Emergency laparotomy revealed a bullet track in the left lobe of the liver. Because of the length and depth of the hepatic wound a decision was made to use fibrin glue and balloon tamponade of the bullet track. Within 15 seconds the patient developed severe hypotension with diffuse bleeding from all cut surfaces, followed by fatal cardiac arrest. The second case refers to a 30-year-old white man with a 2-cm stab wound in the right lower chest. An exploratory laparotomy revealed an 8-cm penetrating injury of the liver. Fibrin glue was placed in the laceration and the bleeding stopped immediately. Within 20 sec of introducing the fibrin glue, the patient's systolic blood pressure dropped and remained very tow for several minutes, gradually returning to normal with the administration of fluid and vasopressors. These clinical findings could be explained by an anaphylactic reaction to one or more components of the fibrin glue. Of the three ingredients used to prepare fibrin glue, only cryoprecipitate and bovine thrombin are antigenic and could potentially cause an anaphylactic reaction.
Fluoride (SEDA-11, 1043; SEDA-15, 534) Several recent studies have suggested that sodium fluoride may be effective in vertebral osteoporosis, although the high frequency of adverse effects may limit its use. Exacerbation of rheumatoid arthritis" has been seen on 3
553 occasions after the start of sodium fluoride therapy (25cr). The authors suggested that the apparent complication during treatment may be mediated by stimulation of leukocyte production of reactive oxygen species and other mediators of the acute inflammatory response. Women taking sodium fluoride for postmenopausal osteoporosis complained of extremity pain (26cr). In a patient with severe upper and lower extremity pain, bone scanning showed markedly increased activity along the long bones. After low-dose sodium fluoride therapy for the treatment of osteoporosis was discontinued, the patient promptly became asymptomatic, and the bone scan improved at 10 weeks (27r). Osteomalacia and cortical bone fractures enhanced by pre-existing bone disease have been reported in the case of a 55-year-old woman with autoimmune Addison's disease for 10 years (28c). After 18 month's treatment with sodium fluoride for osteoporosis she developed radiographic, and scintigraphic evidence of unexpected stress fractures of several ribs and of left sacroiliac and the symphyseal joint. According to the investigators, the sodium fluoride together with the lack of adrenal androgens, was responsible for the onset of pelvic stress fractures, which usually occur in older subjects.
T-Hydroxybutyrate Sixteen cases of adverse effects due to a new health-food product, ~,-hydroxybutyrate, have been reported to the San Francisco Bay Area Regional Poison Control Center in a 5-month period (29c). Cases have also been reported in 8 other states. Adverse effects included coma (4 patients) and tonic-clonic seizure-like activity (2 patients). Doses ranged from 1/4 teaspoon to 4 tablespoons. Acute symptoms resolved within 7 hours. The use of y-hydroxybutyrate as an anesthetic agent was investigated during the 1960s until seizures and lack of analgesia precluded its use. It was recently introduced in the health-food market as a food supplement for body builders, with claims of anabolic effects as a result of stimulation of growth hormone release. It remains under investigational new drug status with the Food and Drug Administration and is illegal for over-thecounter sale. The Food and Drug Branch of
554 the California Department of Health Services has prohibited further sales in California, as have health departments in Florida and South Carolina.
Magnesium (SED-11, 1043; SEDA-IO, 433; SEDA-15, 535) Magnesium sulfate has long been safely used in obstetric practice for the treatment of toxemia (30R). TWO cases of severe hyperkalemia have been reported in pregnant intravenous drug abusers during prolonged parenteral magnesium sulfate therapy, in the absence of any obvious cause (31c). The serum potassium concentration was returned to normal after magnesium was discontinued. Hypermagnesemia was probably responsible for the reversible hyperkalemia. Other adverse effects of magnesium salts have been reported in 150 patients with suspected acute myocardial infarction who received magnesium infusions (32c). There was a significantly increased incidence of atrioventricular conduction disturbances. The results suggested that patients with acute ischemic heart syndromes do not benefit from intravenous magnesium supplementation. In the case of a 3-week-old girl extreme hypermagnesemia, was caused by an overdose of magnesium oxide, prescribed as a laxative. The patient was treated with a combination of hyperhydration, forced diuresis and natriuresis and the administration of intravenous calcium and insulin (33c).
Nicotine transdermal patch Tonnesen and co-workers (34 a) studied the safety and efficacy of a transdermal nicotine patch used in support of smoking cessation. During the treatment period 21% of the 145 subjects in the nicotine group reported one or more adverse effects, compared with 15% in the placebo group of 144. The most frequent symptoms with nicotine compared with placebo were headache (4%), nausea (4%), and vertigo (4%). One subject had to stop treatment permanently after 4 days because of nausea. Mild itching under the nicotine patch for 15-30 minutes was observed in 14% of the subjects, as well as erythema (7.3%) and acute eczema, which persisted for several days after with-
Chapter 51 N.H. Choulis drawal (1.4%).
Pamidronate Disodium pamidronate, an aminohydroxypropylidene bisphosphonate has been approved by the F D A for intravenous use in the treatment of hypercalcemia associated with malignancy, with or without bone metastases (35r). The most common adverse effects are transient fever and leukopenia, occurring typically during the first 2 days of the first course of treatment. Nausea was observed with doses of more than 90 mg. Mild thrombophlebitis may occur at the infusion site. Two patients with otosclerosis developed severe hearing loss after treatment. In another study (36 R) the reported adverse effects were fever (12%), lymphopenia (33%), and phlebitis (7%). After oral administration developed gastrointestinal upsets. Scharla et al. (37 r) reported hyperthermia and headache as the predominant adverse effects.
Phenol Cardiac dysrhythmias in children, associated with the administration of phenol (5% in water) during halothane anesthesia occurred in 3 of 16 patients (19%). Three other patients also had dysrhythmias, but those were not attributable to phenol (38c). The use of 5% phenol in water for motor point blocks in children with cerebral palsy anesthetized with halothane was not known to be associated with an increased incidence of cardiac dysrhythmias when administered in the doses and over the duration now reported. However, the safe dose, the duration of administration or absorption of phenol, and the threshold blood concentration at which dysrhythmias may become more pronounced have not been established. In the current small series, 2 patients with phenol blood concentrations greater than 20 ,ug/ml had dysrhythmias attributable to phenol, whereas only 1 patient with a concentration of less than 20 pg/ml had a dysrhythmia. ECG monitoring, particularly with the larger dosages of phenol, may identify a greater incidence of dysrhythmias and is recommended regardless of the anesthetic administered. All dysrhythmias in this study occurred within 30 min of the completion of phenol administration and would have been noticed while the
Miscellaneous drugs and agents Chapter 51 patient was in the operating room or postanesthetic care unit. Thus the procedure appears suitable for day surgery.
Polyacrylonitrile dialyzers The F D A has issued a safety alert about possible life-threatening anaphylactoid reactions associated with the concurrent use of angiotensin coverting-enzyme (ACE) inhibitors and polyacrylonitrile (PAN) dialyzers (39c). The warning was followed by increased reports of this problem in the medical literature, as well as reports to the F D A of severe, sudden, sometimes fatal reactions. Symptoms have included nausea, abdominal cramps, burning, angioedema, and shortness of breath, leading rapidly to severe hypotension. When these symptoms are recognized, dialysis must be stopped immediately and aggressive treatment for anaphylactoid reactions should begin. Antihistamines will not relieve the symptoms. Physicians should not consider this warning as a recommendation to stop prescribing ACE inhibitors when patients are being dialyzed with PAN membranes. The mechanism of the interaction between ACE inhibitors and PAN membrane dialyzers has not been established, and the incidence and scope of the problem are still unknown.
Sclerotherapy Endoscopic esophageal variceal sclerotherapy (EVS) is often used in the treatment of upper gastrointestinal hemorrhage due to esophageal varices. Fever, chest pain, and odynophagia are frequent findings after EVS endoscopy, but tend to be of short duration (40r). Local complications at the site of injection, such as esophageal perforation (1%) and abscess formation (0.3%), are infrequent but associated with substantial mortality. There has been a report of a 59-year-old man with quiescent alcoholic cirrhosis and portal hypertension who developed portal vein thrombosis (41~ Bleeding from gastric varices developed after obliteration of esophageal varices by endoscopic sclerotherapy. At histopathology, there was amorphous, eosinophilic material within the clot staining negatively for fibrin and with an appearance similar to the sclerosant injected at sclerotherapy. This finding, not
555 reported previously, provides convincing evidence for the causal relation between portal vein thrombosis and endoscopic sclerotherapy. An unusual complication of sclerotherapy, has been reported (42c). A 72-year-old man was admitted as an emergency case with hematemesis and melena. He received endoscopic sclerotherapy for a bleeding duodenal ulcer with fatal outcome.
Silicone (SED-IO, 909; SED-11, 1034; SEDA11, 434; SEDA-12, 419; SEDA-13, 478; SEDA15, 536) Silicone, has become one of the most commonly used biomaterials in medicine over the past 40 years, breast augmentation being one of its main uses. This is generally performed by the insertion of a prosthesis consisting of a silicone rubber bag filled with silicone gel or saline. However, silicone that is in direct contact with tissues can lead to granuloma formation after weeks or years (43 R) while it may occasionally, migrate to regional lymph nodes or remote areas and produce palpable granulomatous reactions. In addition benign tissue reactions to silicone, especially in the breast, may clinically and radiologically mimic cancer and can create problems in diagnosis and management (44r). Two Oriental women who had had silicone injected into their breasts 20 and 22 years previously, presented with breast masses interpreted as being malignant on physical, mammographic, and surgical examination (45c). In both cases lack of familiarity with the benign tissue reaction to silicone led to unnecessary surgery. Silicone implants can also provoke systemic adverse effects. Vasey and co-workers (46 c) have seen more than 20 women with muscle pain, joint pain, swelling, pulmonary disease (including plural effusions, infiltrates, and reduced diffusing capacity), dry eyes and mouth dysphagia, bladder dysfunction, neurological abnormalities, and skin disease (including localized and diffuse scleroderma-like changes). It is assumed that the rupture of a gel-filled prosthesis is the most likely cause of these systemic symptoms. According to the authors, the gel-filled prosthesis in some of their patients was intact, but amorphous material characteristic of silicone was identified by light microscopy in surgically removed fibrous tissue.
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Table 1 Miscellaneous reports Drug/product
Complication
Ref. no.
Acamprosate Acetate dialysate Aluminum Activated charcoal Cardiopulmonary bypass Colorants Disodium clodronate Disulfiram Etidronate Fluorescein Galactosoaminoglucuronoglycan sulfate Gallium nitrate Gentian violet Glutamate
Multiform erythema Hypersensitivity reaction Acute aluminum poisoning Pulmonary aspiration Pancreatitis (300 cases) Urticaria Gastrointestinal effects (7 cases) Hepatitis, psychiatric effects Pseudogout (1 case) Severe anaphylactic reaction Gastrointestinal diseases (40 cases) Asymptomatic hypophosphatemia Tissue discoloration Facial pressure and burning sensations (1 case) Granuloma, sterile discharge Hemorrhagic complications Nausea, dyspnea, bradycardia Anaphylactic shock Minor discomfort, skin irritation (216 cases) Nausea (200 cases) Stenosis of the ileum/jejunum, atresia Hypotension Genital ulcers and vulvitis (138 cases) Transient leukopenia, pulmonary distress, death Rectal necrosis Renal failure, CNS depression Microembolization (28 cases) Nausea, diarrhea, stomach irritation Panic disorders Hypernatremia (1 case) Diarrhea (35 cases) Wheezing, urticaria, bronchospasm, anaphylaxis Bronchoconstriction Respiratory difficulties, umbilical granulomas Cerebrorenal oxalosis (3 cases)
55c 56c 57c 58c 59 R 60c 61 r 62c, 63 R 64r 65c 66 R 67 R 68 ~ 69~
Gore-Tex (Polytetrafluoroethylene) Hypertonic saline amnioinfusion Insecticide (Organophosphate) Latex Lumbotrain (back support) Matrix Methylene blue Methylmethacrylate Nonoxynal-9 contraceptive sponge Perfluorocarbon Phosphate enemas Polyethylene glycol Polytetrafluoroethylene paste Potassium chloride Sodium lactate Sodium phosphate Sorbitol Sulfite (oral) Sulfur dioxide Talc Xylit infusion (calcium oxalate)
In a n o t h e r study (47 c) similar g r a n u l o m a t o u s i n f l a m m a t o r y reactions developed w h e n silicone elastomers were used as skin expanders. This was a t t r i b u t e d to leakage o f particles of the plastic material t h r o u g h the e x p a n d e r wall. Finally W h i t e et al. (48 c) presented the case of a 40-year-old m a n with f a c i a l edema resulting from a n i n f l a m m a t o r y reaction to a silic o n e - r u b b e r implant, inserted 16 years previously for a n a u g m e n t a t i o n rhinoplasty.
70r 71 r 7T 73~ 74~ 75 ~ 76c 77r 78c 79 R 80r 8V 82~ 83c 84r 85c 86~ 87c 88 R 89c 90c
Sodium polystyrene sulfonate The incidence of intestinal necrosis in 752 hospitalized patients w h o h a d received sodium polystyrene sulfonate (SPS) has been reported (49r O f these patients, t17 were exposed within 1 week of surgery. Two cases o f intestinal necrosis were discovered, b o t h in patients w h o h a d received oral SPS in sorbitol within 1 week of surgery. Based o n these 2 cases the postoperative incidence of intestinal necrosis associated with SPS was 1.8%. F o r c o m p a r a -
Miscellaneous drugs and agents
557
Chapter 51
tive purposes, 862 patients were identified who had undergone hemodialysis, renal transplantation, or cardiac transplantation, but did not receive SPS; no cases of idiopathic intestinal necrosis were found. These data suggest that intestinal complications due to SPS in sorbitol may be relatively common postoperatively.
Teflon (SED-11, 1034; SEDA-14, 455) Subureteral injection of Teflon or the Sting procedure, for the management of vesicoureteral reflux has increased in popularity. In a study of 167 children (127 girls, 40 boys) who underwent the Sting procedure, the most significant complication was complete obstruction o f the ureter in 2 patients with third- and fourth-degree reflux, following injection of 1.5 and 2 ml of Teflon (50CR). Percutaneous nephrostomy was used as the initial treatment followed by ureterocystostomy. Also transient post-Sting problems of urinary stasis were seen in 16 of the children. However, in another study, of the treatment of 676 ureters with vesicoureteral reflux by submucosal injection of Teflon, there were 7 non-pathological Teflon granuloma calcifications that had no influence on the results (51~). Finally, a case of pulmonary migration of Teflon in a young woman who was injected 3 times with polytetrafluoroethylene (Teflon) paste has
been reported (52c).
L-Tryptophan L-Tryptophan, an amino acid which has enjoyed increasing popularity as an antidepressant and hypnotic, has recently been held responsible for an epidemic of the eosinophilic myalgia syndrome (53r). However, this syndrome appears to be only part of a spectrum of adverse effects associated with tryptophan. In a case of interstitial pneumonitis and pulmonary vasculitis ascribed to L-tryptophan, unintended rechallenge supported a causal relation (54c). There was neither myalgia nor peripheral eosinophilia. Bronchoalveolar lavage fluid contained 12% eosinophils, but few were present in the surgical lung biopsy specimen. Lung infiltrates receded after withdrawal and treatment with steroids, but dyspnea and pulmonary hypertension persisted. Cyclophosphamide had no effect. Sclerodermiform skin lesions appeared as a late sequel. Chromatographic analysis of the L-tryptophan revealed no suspect impurities.
Miscellaneous Other reports on miscellaneous drugs and their effects are listed in Table 1.
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1213. 8. Ringe JD (1991) The risk of nephrolithiasis with oral calcium supplementation. Calcif Tissue Int., 48, 69-73. 9. Lee GS, Jang HZ, Lee HR, Ahn KS, Kim JM, Lee CJ (1990) A case of cutaneous calcium deposition following extravasation of infused calcium gluconate. Korean J. Dermatol., 28, 464-468. 10. Emmett M, Sirmon MD, Kirkpatrick WG, Nolan CR, Schmitt GW, Cleveland MB (1991) Calcium acetate control of serum phosphorus in hemodialysis patients. Am. J. Kidney Dis., XVll, 544-550. 11. Wentink GH, van den Ingh TSGAM (1992) Oral administration of calcium chloride-containing products: testing for deleterious side-effects. Vet. Q., 14, 76-79. 12. Hanke CW, Higley HR, Jolivette DM, Swanson NA, Stegrnan SJ (1991) Abscess formation and local necrosis after treatment with Zyderm or
558 Zyplast collagen implant. J. Am. Acad. Dermatol., 25, 319-326. 13. Lipsky H (1991) Endoscopic treatment ofvesicoureteral reflux with collagen. Pediatr. Surg. Int., 6, 301-303. 14. Manager D, Gerson J, Constantine RM, Lenzi V (1989) Pulmonary edema and coagulopathy due to Hyskon (32% dextran 70) administration. Anesth. Analg., 68, 686-689. 15. Jediekin R, Olsfanger D, Kessler I (1990) Disseminated intravascular coagulopathy and adult respiratory distress syndrome: life threatening complications of hysteroscopy. Am. J. Obstet. Gynecol., 44, 142 146. 16. Ahmed N, Falcone T, Tulandi T, Houle G (1991) Anaphylactic reaction because of intrauterine 32% dextran-70 instillation. Fertil. Steril., 55, 1014-1016. 17. Picano E, Lattanzi F, Orlandini A, Seveso G, D'Urbano M, Landi P, Raciti M, Agati L, Marini C (1991) Dipyridamote stress echocardiography. Coron. Artery Dis., 2, 559-563. 18. Mazeika P, Nihoyannopoulos P, Joshi J, Oakley CM (1992) Uses and limitations of high dose dipyridamole stress echocardiography for evaluation of coronary artery disease. Br. Heart J., 67, 144-149. 19. Casanova R, Fabbri M, Patroncini A, Jacobi F, Pirazzini L, Maresta A (1991) Tallio ed echo piridamolo nella selezione precoce dei pazienti a rischio dopo infarto miocardico acuto. Quale test? Con quale dose? G. Ital. Cardiol., 21, 377-386. 20. Curro Dossi B, Cirafisi C, Ravasio A, Nardeli E, Pasquinelli M, Lorusso S, Anzini P, Rizzuto N (1991) Chronic inflammatory polyradiculoneuropathy with antiganglioside antibodies: possible trigger action of exogenous gangliosides. Case report. Riv. Neurobiol. 37, 243-245. 21. Kram HB, Reuben BI, Fleming AW (1988) Using of fibrin glue in hepatic trauma. J. Trauma, 28, 1195-1201. 22. Spotnitz WD, Dalton S, Baker JW (1987) Reduction of perioperative hemorrhage by anterior mediastinal spray application of fibrin glue during cardiac operations. Ann. Thorae. Surg., 44, 529531. 23. Jessen C, Sharma P (1985) Use of fibrin glue in thoracic surgery. Ann. Thorac. Surg., 39, 522524. 24. Berguer R, Staerkel RL, Moore EE, Moore FA, Galloway WB, Mockus MB (1991) Warning: Fatal reaction due to the use of fibrin glue in deep hepatic wounds. Case reports. J. Trauma, 31, 408411. 25. Duel PB, Chesnut CH (1991) Exacerbation of rheumatoid arthritis by sodium fluoride treatment of osteoporosis. Arch. Intern. Med., 151, 783-784. 26. Gips S, Cohen L, Hardoff R (1991) Stress fracture in osteoporosis treated with sodium fluo-
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ride. Clin. Nucl. Med, 16, 183 184. 27. Weingrad TR, Eymontt MJ, Martin JH (1991) Periostitis due to low dose fluoride intoxication demonstrated by bone scanning. Clin. Nuel. Med., 16, 59-60. 28. Weryha G, Aghassian C, Morel J, Leclerc J, Hartemann P (1990) Complications osseuses de la fluorotherapie: influence de la carence en androgenes. Ann. Endocrinol., 51, 218-221. 29. Dyer JE (1991) ~'-Hydroxybutyrate: a healthfood product producing coma and seizure-like activity. Am. J. Emerg. Med., 9, 321-324. 30. Pritchard JA (1955) The use of the magnesium ion in the management of eclamptogenic toxemias. Surg. Gynecol. Obstet., 100, 131-140. 31. Spital A, Greenwell R (1991) Severe hyperkalemia during magnesium sulfate therapy in two pregnant drug abusers. South. Med. J., 84, 919-921. 32. Feldstedt M, Boesgaard S, Bouchelouche P, Svenningsen A, Brooks L, Lech Y, Skagen K (1991) Magnesium substitution in acute ischaemic heart syndromes. Eur. Heart J., 12, 1215-1218. 33. Versteegh FGA, Van-Vught AS, Vande Walle JGS, Rademaker CMA ( 199 I) M agnesiumintoxicatie bij een zuigeling. Ned. Tijdschr. Geneeskd., 135, 11861188. 34. Tonnesen P, Norregaard J, Simonsen K, Sawe U (1991) A double-blind trial of a 16-hour transdermal nicotine patch in smoking cessation. New Engl. J. Med., 325, 311 315. 35. Editorial (1992) Pamidronate. Med. Lett., 34, 12. 36. Ignoffo RJ, Tseng A (1991) Focus on pamidronate: A biphosphonate compound for the treatment of hypercalcemia in malignancy. Hosp. Formul., 26, 774-786. 37. Scharla SH, Graner A, Ziegler R (1991) Therapie des morbus Paget mit dem biphosphonat pamidronat (AHPrBP, fruher APD). Klin. Wochenschr., 69, 25-30. 38. Morrison JE, Matthews D, Washington R, Fennessey PV, Harrison LM (1991) Phenol motor point blocks in children: plasma concentrations and cardiac dysrhythmias. Anesthesiology, 73, 359-362. 39. FDA Medical Bulletin (1992) Severe allergic reactions associated with dialysis and ACE inhibitors. Vol. 22, No. 1, p. 4. 40. Zeller FA, Cannan CR, Prakash UBS (1991) Thoracic manifestations after esophageal variceal sclerotherapy. Mayo Clin. Proe., 66, 727-732. 41. Korula J, Yellin A, Kanel GC, Nickols P (1991) Portal vein thrombosis complicating endoscopic variceal sclerotherapy. Convincing further evidence. Dig. Dis. Sci., 36, 1164-1167. 42. Dell Abate P, Spaggiari L, Carboynani P, Soliani P, Karake I, Foggi E (1991) An unusual complication of sclerotherapy. Endoscopy, 23, 352353. 43. Savrin RA, Martin EW Jr, Ruberg RL (1979)
Miscellaneous drugs and agents
Chapter 51
Mass lesion of the breast after augmentation mammoplasty. Arch. Surg., 114, 1423-1424. 44. Sergott TJ, Limoli JP, Baldwin CM (1986) Human adjuvant disease, possible autoimmune disease after silicone implantation: a review of the literature, case studies and speculation for the future. Plast. Reconstr. Surg., 78, 104-114. 45. Warner E, Lipa M, Pearson D, Pearson D, Wizel HA (1991) Silicone mastopathy mimicking malignant disease of the breast in S.E. Asian patients. Can. Med. Assoc. J., 144, 569-571. 46. Vasey FB, Espinoza LR, Osuna PM, Seleznick M J, Brozena SJ, Penske NA (1991) Silicone and rheumatic disease: replace implant or not. Arch. Dermatol., 127, 907. 47. Maturri L, Azzolini A, Campiglio GL, Tardito E (1991) Are synthetic prostheses really inert? Preliminary results of a study on the biocompatibility of dacron vascular prostheses and silicone skin expanders. Int. Surg., 76, 115-118. 48. White MI, Smart RM, Macgregor DM, Macgregor DM, Rayner CRW, Smith FW (1991) Recurrent facial oedema associated with a siliconerubber implant. Br J. Dermatol., 125, 183 185. 49. Gerstaman BB, Kirkman R, Platt R (1992) Intestinal necrosis associated with postoperative orally administered sodium polystyrene sulfonate in sorbitol. Am. J. Kidney Dis., 20, 159 161. 50. Perovic S, Smoljanic D, Scepanovic D, Vukodinovic V (1991) Ureteral obstruction caused by subureteral Teflon injection. Pediatr. Surg. Int., 6, 283 286. 51. Sauvage P, Geiss S, Dhaoui R, Marcellin L, Becmeur F, Nieva H (1991) Analysis and technical refinements of endoscopic treatment of vesicoureteral reflux in children with a 40-month follow up. Pediatr. Surg. Int., 6, 277-280. 52. Claes H, Stroobants D, van Meerbeek J, Verbeken E, Knockaert D (1991) Re: Pulmonary migration following periurethral polytetrafluoroethylene injection for urinary incontinence. J. Urol., 145, 839 840. 53. Kilbourne EM, Swygert LA, Philen RM, Sun RK, Anerbach RB, Miller L, Nelson DE, Falk H (1991) Interstitial pneumonitis and pulmonary vasculitis in a patient taking an L-tryptophan preparation. Eur. Respir. J., 4, 1033-1036. 54. Bogaerts Y, Van Renterghem D, Vanvuchelen J, Praet M, Michielssen P, Blaton V, Willemot JP (1991) Interstitial pneumonitis and pulmonary vasculitis in a patient taking an L-tryptophan preparation. Eur. Respir. J., 4, 1033-1036. 55. Potgieter A, Opsomer L (1992) Acamprosate as cause of erythema multiforme contested. Lancet, 340, 856 857. 56. Papadakis JT, Patrikarea A, Saradi S, Papakostas K, Leondi A, Vafiadis S (1991) Hypersensitivity reactions during hemodialysis related to the use of acetate dialysate. A case report. Clin. Nephrol.,
559 35, 224-226. 57. Moreno A, Domingnez P, Domingnez C, Ballabriga A (1991) High serum aluminum levels and acute reversible encephalopathy in a 4-year-old boy with acute renal failure. Eur J. Pediatr., 150, 513 514. 58. Givens T, Holloway M, Wason S (1992) Pulmonary aspiration of activated charcoal: a complication of its misuse in overdose management. Pediatr Emerg. Care. 8, 137-140. 59. Del Castillio CF, Harringer W, Warshaw AL, Vlachakes G, Koski G, Rattner DW (1991) Risk factors for pancreatic cellular injury after cardiopulmonary by pass. New Engl. J. Med., 325, 382-387. 60. Bell T (1991) Colourants and drug reactions. Lancet, 338, July 6, 55-56. 61. Lepore L, Pennesi M, Barbi E, Pozzi R (1991) Treatment and prevention of osteoporosis in juvenile chronic arthritis with disodium clodronate. Clin. Exp. Rheumatol., 9, (Suppl. 6), 33 35. 62. Bierbaum C, Neef J, Damaschke H J, Linde J (1991) Arzneimittelhepatitis durch Disulfiram. Z Klin. Med., 46, 275-278. 63. Larson EW, Olincy A, Rummans TA, Morse RM (1992) Disutfiram treatment of patients with both alcohol dependence and other psychiatric disorders: a review. Alcohol Clin. Exp. Res., 16, 125-130. 64. Gallacher SJ, Boyle IT, Capell HA (1991) Pseudogout associated with the use of cyclical etidronate therapy. Scott. Med. J., 36, 49. 65. Gomez-Ulla F, Gutierrez C, Seoane I (1991) Severe anaphylactic reactions to orally administered fluorescein. Am. J. Ophthalmol., 109, 94. 66. Fioravanti A, Franci A, Anselmi F, Fattorini L, Marcolongo R (1991) Clinical efficacy and tolerance of galactosoaminoglucuronoglycon sulfate in the treatment of osteoarthritis. Drugs Exp. Clin. Res. XVII, 41-44. 67. Warrell RP, Murphy WK, Schulman P, O'Dwyer P J, Heller G ( 1991) A randomized d o ubleblind study of gallium nitrate compared with etidronate for acute control of cancer related hypercalcemia. J. Clin. Oncol., 9, 1467 1475. 68. Harris MJ (1991) Gentian violet. Med. J. Austr., 154, 782. 69. Thomassen A, Nielsen TT, Bagger JP, Pedersen AK, Henningsen P (1991) Antiischemic and metabolic effects of glutamate during pacing in patients with stable angina pectoris secondary to either coronary artery disease or syndrome X. Am_ J. Cardiol., 68, 291 295. 70. Lemagne JM, Liu C (1990) Complications of frontalis suspension using polytetrafluoroethylene (Gore-Tex). Orbit, 10, 2%31. 71. Singh N, Asopa L (1990) Changes in plasma fibrinogen level with hypertonic saline amnioinfusion. J. Inst. Med., 12, 125-132. 72. Bush HS, Woolbert SC, Taylor RW (1990)
560 Bradycardia in a patient exposed to insecticide. Prim. Cardiol., 16, 21-23. 73. Gaignon I, Veyckemans F, Gribomont BF (1991) Latex allergy in a child: report of a case. Acta Anaesth. Belgica, 42, 219 223. 74. Valle-Jones JC, Walsh H, O'Hara J, O'Hara H, Davey NB, Richards HH (1992) Controlled trial of a back support (Lumbotrain) in patients with non-specific low back pain. Curt. Meal Res. Opin., 12. 604-613. 75. Oliviero U, Sorrentino GP, De Paola P, Tranfaglia E, D'Alessandro A, Carifi S, Porfido FA, Cerio R (1991) Effects of the treatment with matrix on elderly people with acute articular degeneration. Drugs Exp. Clin. Res., XVII, 45-51. 76. Dolk H (1991) Methylene blue and atresia or stenosis of ileum and jejunum. Lancet, 338, 10211022. 77. Esemenli T, Toker K, Lawrence R (1991) Hypotension associated with methylmethacrylate in partial hip arthroplasties. Orthoped Rev., XX, 619623. 78. Kreiss J, Ngugi E, Holmes K, Ndinya-Achola J, Waiyaki P, Roberts PL, Kimata J, Fleming TR, Plummer F (1992) Efficacy of Nonoxynol 9 contraceptive sponge use in preventing heterosexual acquisition of HIV in Nairobi prostitutes. J. Am. Med. Assoc., 268, 477482. 79. Nyberg SL, Cerra FB (1991) Treatment of severe anaemia with perfluorocarbon blood substitutes: a clinical overview. Clin. Intensive Care, 2, 226-232. 80. Goldman M (1991) Phosphate enemas in childhood. Br. Med. J., 302, 1273-1274.
Chapter 51
N.H. Choulis
81. Venkataraman BV, Nagarani MA (1991) Precautionary note on use of polyethylene glycol as a drug solvent. Indian J. Phys. Pharmacol., 35, 207 208. 82. Smart RF (1991) Polytef paste for urinary incontinence. Aust. New Zealand .L Surg., 61, 663-666. 83. Z u k o f M (1991) Patient preference study of two potassium chloride supplements: Slow-K R and Micro-K R 10 Extencaps R. Clin. Then., 13, 425429. 84. Shear MK, Feyer AJ, Ball G, Josephson S, Fitzpatrick M, Gitlin B, Frances A, Liebowitz M, Klein D F (1991) Vulnerability to sodium lactate in panic disorder patients given cognitive-behavioral therapy. Am. J. Psych., 148, 795 797. 85. Aradhye S, Brensilver JM (1991) Sodium phosphate-induced hypernatremia in an elderly patient: a complex pathophysiologic state. Am. J. Kidney Dis., XVIII, 609-611. 86. Bodiga MS, Jain NK, Casanova C, Pitchumoni CS (1990) Diarrhea in diabetics: the role of sorbitol. J. Am. Coll. Nutr., 9, 578-582. 87. Frick WE, Lemanske RF (1991) Oral sulfite sensitivity and provocative challenge in a 2 year old. J. Asthma, 28, 221-224. 88. Tewari A, Shukla NP (1991) Air pollution adverse effects of sulfur dioxide. Rev. Environ. Health, 9, 3946. 89. Sparrow SA, Hallam LA (1991) Talc granulomas. Br. Meal J., 303, 58. 90. Bergmann M, Silling-Engelhardt G, Schnabel R, Glucotta F (1991) Therapiebedingte zerebrorenale oxalose? Z. Gesamte Inn. Med., 46, Suppl., 101-106.
51
Miscellaneous drugs and agents
Aminohydroxypropylidenebisphosphonate (APD) Two middle-aged women with stapedial otosclerosis and sensorineural hearing loss were treated with APD. There was no effect on the Schwartze sign either during or after therapy. There were no changes in audiometry during the first year, but a few weeks after this, both patients complained of sudden deterioration of their pre-existing hearing losses in both ears, with an alteration of tinnitus. One patient became totally bilaterally deaf, while the other retained minimal auditory function in the low frequencies (lCr). It is recommended that sensorineural deafness in selected patients with otosclerosis should be treated with sodium fluoride. Also, patients with Paget's disease treated with A P D must be closely monitored and the drug should be withdrawn if hearing deterioration is found. In another study in which A P D was used intravenously for the treatment of hypercalcemia in malignancies in 104 patients, 13% developed transient fever (2r
On occasions he also ingested other aspartamecontaining products. After discontinuation of aspartame-containing products all the nodules resolved within 12 days. The mechanism by which aspartame induces panniculitis is uncertain, but it may represent a hypersensitivity reaction to aspartame or one of its breakdown products (4 r, 5r). Finally, there has been a report of a 64-yearold man who complained of moderate frontal headache and slight depression on 2 occasions the day after taking aspartame, which was thereafter avoided (6r). On resuming aspartame a few years later he developed unusual daytime drowsiness, sleeping for up to 18 hours a day, followed by frontal non-throbbing headache, shaking chills, lethargy, miM confusion, and myalgia. The symptoms began to abate the day after he stopped taking aspartame. Calcium (SEDA-15, 532)
The question of whether a high calcium intake might increase the risk of nephrolithiasis has been discussed (7r). It was concluded that in patients who are at risk of developing Aspartame (SED-1, 913; SED-11, 1038; SEDA- nephrolithiasis or even in patients with a 8, 450; SEDA-IO, 437; SEDA-11, 432) positive history of nephrolithiasis, calcium can be administered for the treatment of osteopoThere are previous reports that aspartame rosis, provided that these patients are carefully can cause urticaria, angioedema, and granulo- monitored (8c). Concomitant therapy with matus septal panniculitis. There is now a report thiazides and dietary counselling can reduce that it can also induce lobular panniculitis (3c). the risk of nephrolithiasis associated with calThis happened in a 57-year-old diabetic cium. white man who developed several tender subA case of cutaneous calcium deposition, has cutaneous nodules on his back and arms. He been reported after extravasation of intravehad been taking 6-7 packs of aspartame as a nously infused 10% calcium gluconate, used for sugar substitute (35 mg per pack) and 3 6 4 8 the treatment of hypocalcemic tetany in a oz of aspartame-containing soft drinks per day. 1-month-old neonate (9c). After extravasation of the infused solution, marked swelling and erythema rapidly developed over the right 9 1994 Elsevier Science B.V. All rights reserved lateral malleolus. Histopathological examinaSide Effects of Drugs Annual 17 J.K. Aronson and C.J. van Boxtel, eds. tion of a nodule taken from the scalp showed 551
552 amorphous masses throughout the dermis and around the vein, identified as calcium with von Kossa's stain. Of 91 hyperphosphatemic dialysis patients taking calcium edetate 16 developed mild transient hypercalcemia (10CR). Oral administration of a calcium chloride-containing product caused minor to severe damage to the mucosa of the upper gastro-intestinal tract (llC). The gel solution of the drug was highly caustic, while the oil emulsion appeared to be relatively safe.
Collagen (SED-IO, 909; SED-11, 1035; SEDA9, 431; SEDA-IO, 432,- SEDA-13, 474) The incidence, clinical presentation, pathophysiology, and possible treatment of 2 rare but clinically important complications of tissue augmentation with Zyderm and Zyplast collagen implants have been described (12r). Abscesses as a manifestation of hypersensitivity to bovine collagen occur rarely (4 in 10 000 cases) and may persist for weeks. Localized tissue necrosis also occurs rarely (9 in 10 000 cases) after implantation and is probably the result of local vascular interruption and not a hypersensitivity reaction. The incidence varies greatly between the anatomic sites of implantation, but more than half of the cases involve the glabellar region, because of its unique vascular distribution. Lipsky (13 c) gave submucosal injections of bovine collagen to 1 boy, 41 girls, and 9 women. One child in whom pretreatment collagen testing had been negative developed anaphylactic shock, which was controlled by the administration of adrenergic agents and corticosteroids. In another girl an allergic rash appeared after collagen injection.
Dextran-70 (SEDA-16, 406; see also Chapter 36) Dextran-70 is a high molecular weight dextran, widely used as a distending medium for hysteroscopy. The use of large volumes of dextran during this procedure has been associated with adverse effects, including adult respiratory distress syndrome, pulmonary edema, bleeding coagulopathy and anaphylactic reactions (14 r, 15r). Detailed clinical observations in 3 patients with severe anaphylactic reactions
Chapter 51 N.H. Choulis after hysteroscopy made the diagnosis of dextran-induced anaphylactic reactions quite certain (16c). In all the patients the reaction occurred about 10 minutes after exposure to dextran. Presumably this is the period of time required for absorption from the uterine circulation.
Dipyridamole (SEDA-15, 533; SEDA-16, 412, see also Chapter 37) Dipyridamole, a potent coronary arteriolar vasolidator, is used with 201 thallium imaging for the detection of coronary artery disease. However, about two-thirds of patients experienced some adverse effects, e.g. nausea, facial flushing, headache, after dipyridamole infusion and some required nitrates for angina (17R). In another study, it has been reported that 13 of 16 patients developed chest pain, 1 had prolonged ischemia, and in 3 cases there was hypotension associated in 1 case with sinus bradycardia (18CR). Casanova et al. (19c) detected 1 case of ischemic ventricular dysfunction.
Exogenous gangliosides Exogenous gangliosides offer partial protection in experimental allergic neuritis. However, Guillain-Barr6 syndrome has been observed during ganglioside treatment. A case has been reported of chronic inflammatory polyradiculoneuropathy during ganglioside therapy (20c). A 58-year-old man with signs of vertebral spondylosis, was treated with a ganglioside mixture (100 mg daily intramuscularly). After 10 days he complained of tingling sensations in all limbs and some days later of weakness. He had intense sweating, a flaccid distal tetraparesis, mild sensory loss, and hyporeflexia with ankle areflexia. Electrophysiology showed a prevalent motor neuropathy with conduction block and delay or absence of F responses in all limbs. Cerebrospinal fluid (CSF) protein content was high (0.92 g/l) with oligoclonal bands and a normal cell count. Antibody investigation showed IgG to among others GM1 in both serum and CSF. Serum antiGM1 antibody titer was very high: 1:1280 (normal value less than 1:20). The patient was treated with intravenous human immunoglobulin with benefit.
Miscellaneous drugs and agents Chapter 51 The chronological relation between ganglioside administration and the onset of symptoms as well as high anti-GM1 serum antibodies justify concerns about a possible trigger action of exogenous gangliosides in this immune neuropathy.
Fibrin glue Fibrin glue is a physiological epoxy glue used in a variety of clinical situations including bleeding, following organ injury (21c), cardiac surgery (22c), and dural defects (2Y). Two cases of severe hypotension after the use of fibrin glue for hemostasis in hepatic injuries have been reported (24c). A 36-year-old black man was brought to the hospital emergency department after sustaining a gunshot wound to the left lower chest. Emergency laparotomy revealed a bullet track in the left lobe of the liver. Because of the length and depth of the hepatic wound a decision was made to use fibrin glue and balloon tamponade of the bullet track. Within 15 seconds the patient developed severe hypotension with diffuse bleeding from all cut surfaces, followed by fatal cardiac arrest. The second case refers to a 30-year-old white man with a 2-cm stab wound in the right lower chest. An exploratory laparotomy revealed an 8-cm penetrating injury of the liver. Fibrin glue was placed in the laceration and the bleeding stopped immediately. Within 20 sec of introducing the fibrin glue, the patient's systolic blood pressure dropped and remained very tow for several minutes, gradually returning to normal with the administration of fluid and vasopressors. These clinical findings could be explained by an anaphylactic reaction to one or more components of the fibrin glue. Of the three ingredients used to prepare fibrin glue, only cryoprecipitate and bovine thrombin are antigenic and could potentially cause an anaphylactic reaction.
Fluoride (SEDA-11, 1043; SEDA-15, 534) Several recent studies have suggested that sodium fluoride may be effective in vertebral osteoporosis, although the high frequency of adverse effects may limit its use. Exacerbation of rheumatoid arthritis" has been seen on 3
553 occasions after the start of sodium fluoride therapy (25cr). The authors suggested that the apparent complication during treatment may be mediated by stimulation of leukocyte production of reactive oxygen species and other mediators of the acute inflammatory response. Women taking sodium fluoride for postmenopausal osteoporosis complained of extremity pain (26cr). In a patient with severe upper and lower extremity pain, bone scanning showed markedly increased activity along the long bones. After low-dose sodium fluoride therapy for the treatment of osteoporosis was discontinued, the patient promptly became asymptomatic, and the bone scan improved at 10 weeks (27r). Osteomalacia and cortical bone fractures enhanced by pre-existing bone disease have been reported in the case of a 55-year-old woman with autoimmune Addison's disease for 10 years (28c). After 18 month's treatment with sodium fluoride for osteoporosis she developed radiographic, and scintigraphic evidence of unexpected stress fractures of several ribs and of left sacroiliac and the symphyseal joint. According to the investigators, the sodium fluoride together with the lack of adrenal androgens, was responsible for the onset of pelvic stress fractures, which usually occur in older subjects.
T-Hydroxybutyrate Sixteen cases of adverse effects due to a new health-food product, ~,-hydroxybutyrate, have been reported to the San Francisco Bay Area Regional Poison Control Center in a 5-month period (29c). Cases have also been reported in 8 other states. Adverse effects included coma (4 patients) and tonic-clonic seizure-like activity (2 patients). Doses ranged from 1/4 teaspoon to 4 tablespoons. Acute symptoms resolved within 7 hours. The use of y-hydroxybutyrate as an anesthetic agent was investigated during the 1960s until seizures and lack of analgesia precluded its use. It was recently introduced in the health-food market as a food supplement for body builders, with claims of anabolic effects as a result of stimulation of growth hormone release. It remains under investigational new drug status with the Food and Drug Administration and is illegal for over-thecounter sale. The Food and Drug Branch of
554 the California Department of Health Services has prohibited further sales in California, as have health departments in Florida and South Carolina.
Magnesium (SED-11, 1043; SEDA-IO, 433; SEDA-15, 535) Magnesium sulfate has long been safely used in obstetric practice for the treatment of toxemia (30R). TWO cases of severe hyperkalemia have been reported in pregnant intravenous drug abusers during prolonged parenteral magnesium sulfate therapy, in the absence of any obvious cause (31c). The serum potassium concentration was returned to normal after magnesium was discontinued. Hypermagnesemia was probably responsible for the reversible hyperkalemia. Other adverse effects of magnesium salts have been reported in 150 patients with suspected acute myocardial infarction who received magnesium infusions (32c). There was a significantly increased incidence of atrioventricular conduction disturbances. The results suggested that patients with acute ischemic heart syndromes do not benefit from intravenous magnesium supplementation. In the case of a 3-week-old girl extreme hypermagnesemia, was caused by an overdose of magnesium oxide, prescribed as a laxative. The patient was treated with a combination of hyperhydration, forced diuresis and natriuresis and the administration of intravenous calcium and insulin (33c).
Nicotine transdermal patch Tonnesen and co-workers (34 a) studied the safety and efficacy of a transdermal nicotine patch used in support of smoking cessation. During the treatment period 21% of the 145 subjects in the nicotine group reported one or more adverse effects, compared with 15% in the placebo group of 144. The most frequent symptoms with nicotine compared with placebo were headache (4%), nausea (4%), and vertigo (4%). One subject had to stop treatment permanently after 4 days because of nausea. Mild itching under the nicotine patch for 15-30 minutes was observed in 14% of the subjects, as well as erythema (7.3%) and acute eczema, which persisted for several days after with-
Chapter 51 N.H. Choulis drawal (1.4%).
Pamidronate Disodium pamidronate, an aminohydroxypropylidene bisphosphonate has been approved by the F D A for intravenous use in the treatment of hypercalcemia associated with malignancy, with or without bone metastases (35r). The most common adverse effects are transient fever and leukopenia, occurring typically during the first 2 days of the first course of treatment. Nausea was observed with doses of more than 90 mg. Mild thrombophlebitis may occur at the infusion site. Two patients with otosclerosis developed severe hearing loss after treatment. In another study (36 R) the reported adverse effects were fever (12%), lymphopenia (33%), and phlebitis (7%). After oral administration developed gastrointestinal upsets. Scharla et al. (37 r) reported hyperthermia and headache as the predominant adverse effects.
Phenol Cardiac dysrhythmias in children, associated with the administration of phenol (5% in water) during halothane anesthesia occurred in 3 of 16 patients (19%). Three other patients also had dysrhythmias, but those were not attributable to phenol (38c). The use of 5% phenol in water for motor point blocks in children with cerebral palsy anesthetized with halothane was not known to be associated with an increased incidence of cardiac dysrhythmias when administered in the doses and over the duration now reported. However, the safe dose, the duration of administration or absorption of phenol, and the threshold blood concentration at which dysrhythmias may become more pronounced have not been established. In the current small series, 2 patients with phenol blood concentrations greater than 20 ,ug/ml had dysrhythmias attributable to phenol, whereas only 1 patient with a concentration of less than 20 pg/ml had a dysrhythmia. ECG monitoring, particularly with the larger dosages of phenol, may identify a greater incidence of dysrhythmias and is recommended regardless of the anesthetic administered. All dysrhythmias in this study occurred within 30 min of the completion of phenol administration and would have been noticed while the
Miscellaneous drugs and agents Chapter 51 patient was in the operating room or postanesthetic care unit. Thus the procedure appears suitable for day surgery.
Polyacrylonitrile dialyzers The F D A has issued a safety alert about possible life-threatening anaphylactoid reactions associated with the concurrent use of angiotensin coverting-enzyme (ACE) inhibitors and polyacrylonitrile (PAN) dialyzers (39c). The warning was followed by increased reports of this problem in the medical literature, as well as reports to the F D A of severe, sudden, sometimes fatal reactions. Symptoms have included nausea, abdominal cramps, burning, angioedema, and shortness of breath, leading rapidly to severe hypotension. When these symptoms are recognized, dialysis must be stopped immediately and aggressive treatment for anaphylactoid reactions should begin. Antihistamines will not relieve the symptoms. Physicians should not consider this warning as a recommendation to stop prescribing ACE inhibitors when patients are being dialyzed with PAN membranes. The mechanism of the interaction between ACE inhibitors and PAN membrane dialyzers has not been established, and the incidence and scope of the problem are still unknown.
Sclerotherapy Endoscopic esophageal variceal sclerotherapy (EVS) is often used in the treatment of upper gastrointestinal hemorrhage due to esophageal varices. Fever, chest pain, and odynophagia are frequent findings after EVS endoscopy, but tend to be of short duration (40r). Local complications at the site of injection, such as esophageal perforation (1%) and abscess formation (0.3%), are infrequent but associated with substantial mortality. There has been a report of a 59-year-old man with quiescent alcoholic cirrhosis and portal hypertension who developed portal vein thrombosis (41~ Bleeding from gastric varices developed after obliteration of esophageal varices by endoscopic sclerotherapy. At histopathology, there was amorphous, eosinophilic material within the clot staining negatively for fibrin and with an appearance similar to the sclerosant injected at sclerotherapy. This finding, not
555 reported previously, provides convincing evidence for the causal relation between portal vein thrombosis and endoscopic sclerotherapy. An unusual complication of sclerotherapy, has been reported (42c). A 72-year-old man was admitted as an emergency case with hematemesis and melena. He received endoscopic sclerotherapy for a bleeding duodenal ulcer with fatal outcome.
Silicone (SED-IO, 909; SED-11, 1034; SEDA11, 434; SEDA-12, 419; SEDA-13, 478; SEDA15, 536) Silicone, has become one of the most commonly used biomaterials in medicine over the past 40 years, breast augmentation being one of its main uses. This is generally performed by the insertion of a prosthesis consisting of a silicone rubber bag filled with silicone gel or saline. However, silicone that is in direct contact with tissues can lead to granuloma formation after weeks or years (43 R) while it may occasionally, migrate to regional lymph nodes or remote areas and produce palpable granulomatous reactions. In addition benign tissue reactions to silicone, especially in the breast, may clinically and radiologically mimic cancer and can create problems in diagnosis and management (44r). Two Oriental women who had had silicone injected into their breasts 20 and 22 years previously, presented with breast masses interpreted as being malignant on physical, mammographic, and surgical examination (45c). In both cases lack of familiarity with the benign tissue reaction to silicone led to unnecessary surgery. Silicone implants can also provoke systemic adverse effects. Vasey and co-workers (46 c) have seen more than 20 women with muscle pain, joint pain, swelling, pulmonary disease (including plural effusions, infiltrates, and reduced diffusing capacity), dry eyes and mouth dysphagia, bladder dysfunction, neurological abnormalities, and skin disease (including localized and diffuse scleroderma-like changes). It is assumed that the rupture of a gel-filled prosthesis is the most likely cause of these systemic symptoms. According to the authors, the gel-filled prosthesis in some of their patients was intact, but amorphous material characteristic of silicone was identified by light microscopy in surgically removed fibrous tissue.
556
Chapter 51
N.H. Choulis
Table 1 Miscellaneous reports Drug/product
Complication
Ref. no.
Acamprosate Acetate dialysate Aluminum Activated charcoal Cardiopulmonary bypass Colorants Disodium clodronate Disulfiram Etidronate Fluorescein Galactosoaminoglucuronoglycan sulfate Gallium nitrate Gentian violet Glutamate
Multiform erythema Hypersensitivity reaction Acute aluminum poisoning Pulmonary aspiration Pancreatitis (300 cases) Urticaria Gastrointestinal effects (7 cases) Hepatitis, psychiatric effects Pseudogout (1 case) Severe anaphylactic reaction Gastrointestinal diseases (40 cases) Asymptomatic hypophosphatemia Tissue discoloration Facial pressure and burning sensations (1 case) Granuloma, sterile discharge Hemorrhagic complications Nausea, dyspnea, bradycardia Anaphylactic shock Minor discomfort, skin irritation (216 cases) Nausea (200 cases) Stenosis of the ileum/jejunum, atresia Hypotension Genital ulcers and vulvitis (138 cases) Transient leukopenia, pulmonary distress, death Rectal necrosis Renal failure, CNS depression Microembolization (28 cases) Nausea, diarrhea, stomach irritation Panic disorders Hypernatremia (1 case) Diarrhea (35 cases) Wheezing, urticaria, bronchospasm, anaphylaxis Bronchoconstriction Respiratory difficulties, umbilical granulomas Cerebrorenal oxalosis (3 cases)
55c 56c 57c 58c 59 R 60c 61 r 62c, 63 R 64r 65c 66 R 67 R 68 ~ 69~
Gore-Tex (Polytetrafluoroethylene) Hypertonic saline amnioinfusion Insecticide (Organophosphate) Latex Lumbotrain (back support) Matrix Methylene blue Methylmethacrylate Nonoxynal-9 contraceptive sponge Perfluorocarbon Phosphate enemas Polyethylene glycol Polytetrafluoroethylene paste Potassium chloride Sodium lactate Sodium phosphate Sorbitol Sulfite (oral) Sulfur dioxide Talc Xylit infusion (calcium oxalate)
In a n o t h e r study (47 c) similar g r a n u l o m a t o u s i n f l a m m a t o r y reactions developed w h e n silicone elastomers were used as skin expanders. This was a t t r i b u t e d to leakage o f particles of the plastic material t h r o u g h the e x p a n d e r wall. Finally W h i t e et al. (48 c) presented the case of a 40-year-old m a n with f a c i a l edema resulting from a n i n f l a m m a t o r y reaction to a silic o n e - r u b b e r implant, inserted 16 years previously for a n a u g m e n t a t i o n rhinoplasty.
70r 71 r 7T 73~ 74~ 75 ~ 76c 77r 78c 79 R 80r 8V 82~ 83c 84r 85c 86~ 87c 88 R 89c 90c
Sodium polystyrene sulfonate The incidence of intestinal necrosis in 752 hospitalized patients w h o h a d received sodium polystyrene sulfonate (SPS) has been reported (49r O f these patients, t17 were exposed within 1 week of surgery. Two cases o f intestinal necrosis were discovered, b o t h in patients w h o h a d received oral SPS in sorbitol within 1 week of surgery. Based o n these 2 cases the postoperative incidence of intestinal necrosis associated with SPS was 1.8%. F o r c o m p a r a -
Miscellaneous drugs and agents
557
Chapter 51
tive purposes, 862 patients were identified who had undergone hemodialysis, renal transplantation, or cardiac transplantation, but did not receive SPS; no cases of idiopathic intestinal necrosis were found. These data suggest that intestinal complications due to SPS in sorbitol may be relatively common postoperatively.
Teflon (SED-11, 1034; SEDA-14, 455) Subureteral injection of Teflon or the Sting procedure, for the management of vesicoureteral reflux has increased in popularity. In a study of 167 children (127 girls, 40 boys) who underwent the Sting procedure, the most significant complication was complete obstruction o f the ureter in 2 patients with third- and fourth-degree reflux, following injection of 1.5 and 2 ml of Teflon (50CR). Percutaneous nephrostomy was used as the initial treatment followed by ureterocystostomy. Also transient post-Sting problems of urinary stasis were seen in 16 of the children. However, in another study, of the treatment of 676 ureters with vesicoureteral reflux by submucosal injection of Teflon, there were 7 non-pathological Teflon granuloma calcifications that had no influence on the results (51~). Finally, a case of pulmonary migration of Teflon in a young woman who was injected 3 times with polytetrafluoroethylene (Teflon) paste has
been reported (52c).
L-Tryptophan L-Tryptophan, an amino acid which has enjoyed increasing popularity as an antidepressant and hypnotic, has recently been held responsible for an epidemic of the eosinophilic myalgia syndrome (53r). However, this syndrome appears to be only part of a spectrum of adverse effects associated with tryptophan. In a case of interstitial pneumonitis and pulmonary vasculitis ascribed to L-tryptophan, unintended rechallenge supported a causal relation (54c). There was neither myalgia nor peripheral eosinophilia. Bronchoalveolar lavage fluid contained 12% eosinophils, but few were present in the surgical lung biopsy specimen. Lung infiltrates receded after withdrawal and treatment with steroids, but dyspnea and pulmonary hypertension persisted. Cyclophosphamide had no effect. Sclerodermiform skin lesions appeared as a late sequel. Chromatographic analysis of the L-tryptophan revealed no suspect impurities.
Miscellaneous Other reports on miscellaneous drugs and their effects are listed in Table 1.
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