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HIGH DOSES OF EPINEPHRINE MAY NOT BE BENEFICIAL
NEWS SAFER DRUGS FOR CHILDREN
Final regulations to provide health care practitioners with specific information on the safe and appropriate use of new drugs and biological agents in children were announced Nov. 27 by the U.S. Food and Drug Administration. The regulations require that labels for new drugs and biological agents that are therapeutically important for children or that will be used commonly in children contain information on safe pediatric use. Each year, more than onehalf of newly approved drugs and biological agents that are likely to be used in children do not include information that permits safe and effective use. Without this information, physicians and dentists may be reluctant to prescribe certain drugs for their pediatric patients, or they may prescribe the drugs inappropriately. The new regulations make it more likely that children will receive improved treatment because physicians and dentists will have more complete information on how drugs affect children and what age-appropriate doses are needed. These regulations also will allow the FDA to require pediatric testing of already-marketed products in certain compelling circumstances, such as when a drug commonly is prescribed for use in children, but the absence of adequate labeling could pose significant risks. Pediatric data also can be submitted after a drug already has been approved if the FDA has safety concerns about test-
ing the drug on children before testing it on adults. The FDA will not delay the approval of drugs for adults if the pediatric studies are not yet completed. The pediatric study requirement can be waived for one of the following reasons: dthe FDA finds that the product is likely to be unsafe or ineffective in pediatric patients; dpediatric studies are impossible or highly impractical; dreasonable efforts to develop a pediatric formulation have failed. “These regulations are a very positive step forward in patient care that the Association will monitor very carefully,” said Dr. Daniel Meyer, associate executive director, ADA Division of Science. “Specific patients, patient populations or age groups may respond quite differently to medications than will the general adult population. Even relatively safe and common drugs, such as aspirin, have different indications and contraindications for children. Simply moderating the dosage based on a patient’s size or weight may not be sufficient to ensure appropriate and effective use of drugs or new biological agents. These new regulations appear to greatly benefit providers and patients by improving the quality of care.” NEW PATHOGEN CAUSES INVASIVE INFECTIONS
Candida dubliniensis, a newly described pathogen primarily responsible for localized oral infections in people infected with HIV, has caused more serious systemic infections in three people not infected with HIV, says an article in the
January-February issue of Emerging Infectious Diseases. Yeast infections are common in patients with AIDS and other patients with weakened immune systems. This new disease-causing yeast—C. dubliniensis—is phenotypically very similar to Candida albicans. It was first isolated from oropharyngeal lesions in patients with AIDS living in Dublin, Ireland. It since has been recovered from the oral washings of patients throughout the world who were both infected and not infected with HIV. The role of C. dubliniensis as a pathogen has been limited to oral candidiasis, and no clinically documented invasive infections related to this disease were reported. Recently, however, researchers from The Netherlands, Belgium and Germany found three cases of candidemia—an invasive infection of the blood— caused by the new yeast in patients not infected with HIV whose immune systems had been weakened by chemotherapy or bone marrow transplants. According to the researchers, these may not be the first cases of invasive disease caused by this yeast. The identification and differentiation from other similar yeast has been problematic. Therefore, the incidence and prevalence of this organism and its role in invasive disease have been difficult to establish in the past. HIGH DOSES OF EPINEPHRINE MAY NOT BE BENEFICIAL
Administering high doses of epinephrine is no more effective Continued on page 34
JADA, Vol. 130, January 1999 Copyright ©1998-2001 American Dental Association. All rights reserved.
33
NEWS
Continued from page 33 than administering standard doses during resuscitation efforts in patients with cardiac arrest, say French researchers in the Nov. 26 issue of The New England Journal of Medicine. Researchers conducted a prospective, multicenter study, comparing the use of repeated high doses of epinephrine with repeated standard doses of epinephrine in cases of out-ofhospital cardiac arrest. The research team, led by Pierre-Yves Gueugniaud, M.D., Ph.D., found that patients in the high-dose group were more likely to return to spontaneous circulation and were less likely to die before arriving at the hospital than were patients in a standard-dose group. Patients in the high-dose group, however, were less likely to survive to be discharged from the hospital. Researchers also found that the high-dose regimen improved the rate of successful resuscitation in patients with asystole (no heartbeat), but not in patients with ventricular fibrillation (wildly irregular heartbeat). Overall, the researchers concluded that high doses of epinephrine resulted in a significant improvement in the rate of successful resuscitation, but did not have beneficial effects on long-term survival. The team recommends the continued use of standard doses of epinephrine, especially in cases of ventricular fibrillation, although high doses may be considered when managing prolonged out-of-hospital cardiac arrest cases. OMISSION
A note was omitted from the article “Affordable Implant Prosthetics Using a Screwless
Implant System” by Norman J. Shepherd, D.M.D., which appeared in the December issue of JADA. Dr. Shepherd holds an equity interest in Bicon Implant System, a fact that should have been acknowledged at the end of the article. CORRECTIONS
dThe September JADA article “Dental Procedures Fees 1975 Through 1995: How Much Have They Changed?” by L. Jackson Brown, D.D.S., Ph.D., and Vickie Lazar, M.A., M.S., contained an error. The blue bars in Figure 1 represent the year 1990. dThe November JADA article “Using a Biological Indicator to Detect Potential Sources of Cross-Contamination in the Dental Operatory,” by Raymond W. Hackney Jr., Dr.P.H., and colleagues, contained some errors. First, several numbers that should have been set in superscript were not. Therefore, the first paragraph under the subhead “Results” on page 1571 should read as follows: “Survey of dental patients’ saliva for AHS. The average number of AHS CFUs counted in the survey was 6 × 107 per mL of saliva, ranging from 4 × 106 to 4 × 108. There was an average of 3 × 107 nonhemolytic colony-forming units per mL of saliva, ranging from 1 × 106 to 1 × 108.” On page 1573, under the subhead “Discussion,” the paragraph in the third column should read as follows: “Presence in saliva. AHS were found in high numbers in saliva. The survey of saliva from patients who visited the dental school clinics showed that AHS averaged about 6 × 107 organisms per mL of saliva, ranging
from 4 × 106 to 4 × 108. The nonhemolytic colonies of the various species of the viridans streptococci averaged about half the number of the AHS colonies, although there were some patients with more nonhemolytic than AHS colonies.” In addition, the following sentence at the top of the second column on page 1574 appeared with an incorrect definition of the term “D value.” It should read as follows: “At 75 percent RH, the death rate constant, or D value—the time for 90 percent to die, or one logarithm reduction—was demonstrated to be only two hours, whereas at lower relative humidities of 53 percent and 33 percent, the D value was 12 hours and 60 hours, respectively.10” dIn December JADA, the first footnote in the table of the article “Inhibiting Interspecies Coaggregation of Plaque Bacteria With a Cranberry Juice Constituent,” by Ervin I. Weiss and colleagues, contained an error. The second sentence should read as follows: “Each experiment was performed at least twice.” Compiled by Amy E. Lund, editorial coordinator. MEETINGS
Meeting dates are subject to change. Dentists interested in attending any of the listed meetings should contact the sponsoring organization for more information. dThe 50th annual meeting of the New Orleans Dental Association will be held Sept. 15-18 at the Ernest N. Morial Convention Center in New Orleans. For more information, contact Normalee Ward by
JADA, Vol. 130, January 1999 Copyright ©1998-2001 American Dental Association. All rights reserved.
35
Final regulations to provide health care practitioners with specific information on the safe and appropriate use of new drugs and biological agents in children were announced Nov. 27 by the U.S. Food and Drug Administration. The regulations require that labels for new drugs and biological agents that are therapeutically important for children or that will be used commonly in children contain information on safe pediatric use. Each year, more than onehalf of newly approved drugs and biological agents that are likely to be used in children do not include information that permits safe and effective use. Without this information, physicians and dentists may be reluctant to prescribe certain drugs for their pediatric patients, or they may prescribe the drugs inappropriately. The new regulations make it more likely that children will receive improved treatment because physicians and dentists will have more complete information on how drugs affect children and what age-appropriate doses are needed. These regulations also will allow the FDA to require pediatric testing of already-marketed products in certain compelling circumstances, such as when a drug commonly is prescribed for use in children, but the absence of adequate labeling could pose significant risks. Pediatric data also can be submitted after a drug already has been approved if the FDA has safety concerns about test-
ing the drug on children before testing it on adults. The FDA will not delay the approval of drugs for adults if the pediatric studies are not yet completed. The pediatric study requirement can be waived for one of the following reasons: dthe FDA finds that the product is likely to be unsafe or ineffective in pediatric patients; dpediatric studies are impossible or highly impractical; dreasonable efforts to develop a pediatric formulation have failed. “These regulations are a very positive step forward in patient care that the Association will monitor very carefully,” said Dr. Daniel Meyer, associate executive director, ADA Division of Science. “Specific patients, patient populations or age groups may respond quite differently to medications than will the general adult population. Even relatively safe and common drugs, such as aspirin, have different indications and contraindications for children. Simply moderating the dosage based on a patient’s size or weight may not be sufficient to ensure appropriate and effective use of drugs or new biological agents. These new regulations appear to greatly benefit providers and patients by improving the quality of care.” NEW PATHOGEN CAUSES INVASIVE INFECTIONS
Candida dubliniensis, a newly described pathogen primarily responsible for localized oral infections in people infected with HIV, has caused more serious systemic infections in three people not infected with HIV, says an article in the
January-February issue of Emerging Infectious Diseases. Yeast infections are common in patients with AIDS and other patients with weakened immune systems. This new disease-causing yeast—C. dubliniensis—is phenotypically very similar to Candida albicans. It was first isolated from oropharyngeal lesions in patients with AIDS living in Dublin, Ireland. It since has been recovered from the oral washings of patients throughout the world who were both infected and not infected with HIV. The role of C. dubliniensis as a pathogen has been limited to oral candidiasis, and no clinically documented invasive infections related to this disease were reported. Recently, however, researchers from The Netherlands, Belgium and Germany found three cases of candidemia—an invasive infection of the blood— caused by the new yeast in patients not infected with HIV whose immune systems had been weakened by chemotherapy or bone marrow transplants. According to the researchers, these may not be the first cases of invasive disease caused by this yeast. The identification and differentiation from other similar yeast has been problematic. Therefore, the incidence and prevalence of this organism and its role in invasive disease have been difficult to establish in the past. HIGH DOSES OF EPINEPHRINE MAY NOT BE BENEFICIAL
Administering high doses of epinephrine is no more effective Continued on page 34
JADA, Vol. 130, January 1999 Copyright ©1998-2001 American Dental Association. All rights reserved.
33
NEWS
Continued from page 33 than administering standard doses during resuscitation efforts in patients with cardiac arrest, say French researchers in the Nov. 26 issue of The New England Journal of Medicine. Researchers conducted a prospective, multicenter study, comparing the use of repeated high doses of epinephrine with repeated standard doses of epinephrine in cases of out-ofhospital cardiac arrest. The research team, led by Pierre-Yves Gueugniaud, M.D., Ph.D., found that patients in the high-dose group were more likely to return to spontaneous circulation and were less likely to die before arriving at the hospital than were patients in a standard-dose group. Patients in the high-dose group, however, were less likely to survive to be discharged from the hospital. Researchers also found that the high-dose regimen improved the rate of successful resuscitation in patients with asystole (no heartbeat), but not in patients with ventricular fibrillation (wildly irregular heartbeat). Overall, the researchers concluded that high doses of epinephrine resulted in a significant improvement in the rate of successful resuscitation, but did not have beneficial effects on long-term survival. The team recommends the continued use of standard doses of epinephrine, especially in cases of ventricular fibrillation, although high doses may be considered when managing prolonged out-of-hospital cardiac arrest cases. OMISSION
A note was omitted from the article “Affordable Implant Prosthetics Using a Screwless
Implant System” by Norman J. Shepherd, D.M.D., which appeared in the December issue of JADA. Dr. Shepherd holds an equity interest in Bicon Implant System, a fact that should have been acknowledged at the end of the article. CORRECTIONS
dThe September JADA article “Dental Procedures Fees 1975 Through 1995: How Much Have They Changed?” by L. Jackson Brown, D.D.S., Ph.D., and Vickie Lazar, M.A., M.S., contained an error. The blue bars in Figure 1 represent the year 1990. dThe November JADA article “Using a Biological Indicator to Detect Potential Sources of Cross-Contamination in the Dental Operatory,” by Raymond W. Hackney Jr., Dr.P.H., and colleagues, contained some errors. First, several numbers that should have been set in superscript were not. Therefore, the first paragraph under the subhead “Results” on page 1571 should read as follows: “Survey of dental patients’ saliva for AHS. The average number of AHS CFUs counted in the survey was 6 × 107 per mL of saliva, ranging from 4 × 106 to 4 × 108. There was an average of 3 × 107 nonhemolytic colony-forming units per mL of saliva, ranging from 1 × 106 to 1 × 108.” On page 1573, under the subhead “Discussion,” the paragraph in the third column should read as follows: “Presence in saliva. AHS were found in high numbers in saliva. The survey of saliva from patients who visited the dental school clinics showed that AHS averaged about 6 × 107 organisms per mL of saliva, ranging
from 4 × 106 to 4 × 108. The nonhemolytic colonies of the various species of the viridans streptococci averaged about half the number of the AHS colonies, although there were some patients with more nonhemolytic than AHS colonies.” In addition, the following sentence at the top of the second column on page 1574 appeared with an incorrect definition of the term “D value.” It should read as follows: “At 75 percent RH, the death rate constant, or D value—the time for 90 percent to die, or one logarithm reduction—was demonstrated to be only two hours, whereas at lower relative humidities of 53 percent and 33 percent, the D value was 12 hours and 60 hours, respectively.10” dIn December JADA, the first footnote in the table of the article “Inhibiting Interspecies Coaggregation of Plaque Bacteria With a Cranberry Juice Constituent,” by Ervin I. Weiss and colleagues, contained an error. The second sentence should read as follows: “Each experiment was performed at least twice.” Compiled by Amy E. Lund, editorial coordinator. MEETINGS
Meeting dates are subject to change. Dentists interested in attending any of the listed meetings should contact the sponsoring organization for more information. dThe 50th annual meeting of the New Orleans Dental Association will be held Sept. 15-18 at the Ernest N. Morial Convention Center in New Orleans. For more information, contact Normalee Ward by
JADA, Vol. 130, January 1999 Copyright ©1998-2001 American Dental Association. All rights reserved.
35