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Bendectin and pyloric stenosis in infants
980
December Am. J. Obstet.
Correspondence
We agree that their Fig. 1, b, c, and d depict artifacts but believe they bear no resemblence to our Figs. 1, A to D, 4,5,6, A, 11, and 12. This requires further study. They make no comment on the sperm-like form since they have not studied it extensively. Ultimately we agree with Papoutsis and associates that the probability exists that some viable agent was present in the inoculate in the beagle experiment since the pregnant animals developed clinical signs consistent with human preeclampsia-eclampsia. We are delighted to learn of their efforts to clarify this issue and appreciate the opportunity to answer their letter. J. Lueck J. I. Brewer, M.D., Ph.D. S. Aladjem, M.D. M. Novotny, M.S. Loyola Stritch School of Medicine 2160 South First Ave. Muywood, Illinois 60153 Northwestern University School 303 East Chicago Avenue Chicago, Il1inoi.c 60611
Bendectin
Daniel Department Graduate
University Pittsburgh,
of Epidemiology School of Public of Pittsburgh
Pennsylvania
R. Newpiel,
M.D.
Health 15261
REFERENCE
of Medicine
To the Editors:
Johnson, J. R., Baker, E. A., Potter, P., and Schmidt, R. T. F.: H-y&toxi lualba: Organism or artifact? (AM. J. OBSTET.
Thus, these groups are not comparable, and data obtained retrospectively (by apparently nonblinded interviewers) are subject to possible recall and selection biases. (The investigators assessed possible bias in home interviews of control subjects, and found none, but this is not a situation comparable to the problem mentioned above.) Further investigation of the possible teratogenic effects of this drug is indicated before the conclusions of these authors can be accepted.
1. Vaughan, V. C., McKay, R. J.. and Behrman, R. E.: Nelson’s Textbook of Pediatrics, Philadelphia, 1979, W. B. Saunders.
REFERENCE 1.
15, 1983 Gynecol.
GYNECOL.
146:743,
and pyloric
1983.
stenosis
in infants
To the Editors:
In the article “Bendectin (Debendox) as a risk factor GYNECOL. 144: for pyloric stenosis” (AM. J. OBSTET. 919, 1982), Eskenazi and Bracken reported a casecontrol study of birth defects associated with maternal use of Bendertin during the first trimester of pregnancy. They noted a significant association between maternal use of Bendectin and pyloric stenosis in infants. However, this conclusion is difficult to accept from this study in view of certain characteristics of pyloric stenosis which are distinct from other defects. This lesion, which is rarely symptomatic in the first week of life, usually manifests with vomiting in the second or third weeks, followed by progressive nutritional deterioration. Infants are often sick for several days to a week or more before diagnosis, and may be significantly dehydrated. Once hospitalized, they are stabilized and offered surgical correction, which is relatively safe and successful.’ The control subjects in this study were mothers who had apparently normal infants, and who were almost all interviewed in the hospital before postpartum discharge. The mothers of infants with pyloric stenosis, however, were presumptively all interviewed at home at some time after experiencing up to a week or more of major illness, hospitalization, and surgical correction for their babies.
Eskenazi and Bracken’ reoorted an association between Bendectin usage in the first trimester of pregnancy and subsequent pyloric stenosis in the offspring, although they pointed out that the nature of that association was unclear. Among their findings were 48 (3.4%) sets of twins among Bendectin-exposed women and 11 (0.4%) among a control group almost 70% larger. There is, of course, no need to consider that Bendectin causes twins, and, in any case, the increased likelihood of nausea in a twin pregnancy would be acknowledged by many, even if never actually demonstrated. It may be that nausea itself is associated with pyloric stenosis. In 1975, we reported 21 cases of pyloric stenosis in the English Outcome of Pregnancy Study undertaken by the College of General Practitioners.’ There were 16 males and five females, for an incidence rate of approximately three per 1,000 live births. Included in this total were two cases in which the diagnosis was uncertain (“pylorospasm” and “mild pyloric stenosis”). Eleven of the 2 1 women received an antiemetic or antacid preparation during the total study period (Table I), which ended at 22 weeks’ gestation. Comparable information was provided for women in other abnormal outcome groups in which the offspring survived a minimum of 6 weeks and for a random sample of 500 normal outcomes. The amount of medication given in the pyloric stenosis group (52.4%) was significantly greater than that given in all other groups. Details of the 11 cases (none of which involved the two with uncertain diagnosis) are listed in Table II, in which the first relevant medication is given with the gestational age (days from first day of the last menstrual period). The conclusion drawn is that pyloric stenosis was associated with nausea and vomiting in pregnancy rather than with any specific drug. Whether the pyloric hyper-
December Am. J. Obstet.
Correspondence
We agree that their Fig. 1, b, c, and d depict artifacts but believe they bear no resemblence to our Figs. 1, A to D, 4,5,6, A, 11, and 12. This requires further study. They make no comment on the sperm-like form since they have not studied it extensively. Ultimately we agree with Papoutsis and associates that the probability exists that some viable agent was present in the inoculate in the beagle experiment since the pregnant animals developed clinical signs consistent with human preeclampsia-eclampsia. We are delighted to learn of their efforts to clarify this issue and appreciate the opportunity to answer their letter. J. Lueck J. I. Brewer, M.D., Ph.D. S. Aladjem, M.D. M. Novotny, M.S. Loyola Stritch School of Medicine 2160 South First Ave. Muywood, Illinois 60153 Northwestern University School 303 East Chicago Avenue Chicago, Il1inoi.c 60611
Bendectin
Daniel Department Graduate
University Pittsburgh,
of Epidemiology School of Public of Pittsburgh
Pennsylvania
R. Newpiel,
M.D.
Health 15261
REFERENCE
of Medicine
To the Editors:
Johnson, J. R., Baker, E. A., Potter, P., and Schmidt, R. T. F.: H-y&toxi lualba: Organism or artifact? (AM. J. OBSTET.
Thus, these groups are not comparable, and data obtained retrospectively (by apparently nonblinded interviewers) are subject to possible recall and selection biases. (The investigators assessed possible bias in home interviews of control subjects, and found none, but this is not a situation comparable to the problem mentioned above.) Further investigation of the possible teratogenic effects of this drug is indicated before the conclusions of these authors can be accepted.
1. Vaughan, V. C., McKay, R. J.. and Behrman, R. E.: Nelson’s Textbook of Pediatrics, Philadelphia, 1979, W. B. Saunders.
REFERENCE 1.
15, 1983 Gynecol.
GYNECOL.
146:743,
and pyloric
1983.
stenosis
in infants
To the Editors:
In the article “Bendectin (Debendox) as a risk factor GYNECOL. 144: for pyloric stenosis” (AM. J. OBSTET. 919, 1982), Eskenazi and Bracken reported a casecontrol study of birth defects associated with maternal use of Bendertin during the first trimester of pregnancy. They noted a significant association between maternal use of Bendectin and pyloric stenosis in infants. However, this conclusion is difficult to accept from this study in view of certain characteristics of pyloric stenosis which are distinct from other defects. This lesion, which is rarely symptomatic in the first week of life, usually manifests with vomiting in the second or third weeks, followed by progressive nutritional deterioration. Infants are often sick for several days to a week or more before diagnosis, and may be significantly dehydrated. Once hospitalized, they are stabilized and offered surgical correction, which is relatively safe and successful.’ The control subjects in this study were mothers who had apparently normal infants, and who were almost all interviewed in the hospital before postpartum discharge. The mothers of infants with pyloric stenosis, however, were presumptively all interviewed at home at some time after experiencing up to a week or more of major illness, hospitalization, and surgical correction for their babies.
Eskenazi and Bracken’ reoorted an association between Bendectin usage in the first trimester of pregnancy and subsequent pyloric stenosis in the offspring, although they pointed out that the nature of that association was unclear. Among their findings were 48 (3.4%) sets of twins among Bendectin-exposed women and 11 (0.4%) among a control group almost 70% larger. There is, of course, no need to consider that Bendectin causes twins, and, in any case, the increased likelihood of nausea in a twin pregnancy would be acknowledged by many, even if never actually demonstrated. It may be that nausea itself is associated with pyloric stenosis. In 1975, we reported 21 cases of pyloric stenosis in the English Outcome of Pregnancy Study undertaken by the College of General Practitioners.’ There were 16 males and five females, for an incidence rate of approximately three per 1,000 live births. Included in this total were two cases in which the diagnosis was uncertain (“pylorospasm” and “mild pyloric stenosis”). Eleven of the 2 1 women received an antiemetic or antacid preparation during the total study period (Table I), which ended at 22 weeks’ gestation. Comparable information was provided for women in other abnormal outcome groups in which the offspring survived a minimum of 6 weeks and for a random sample of 500 normal outcomes. The amount of medication given in the pyloric stenosis group (52.4%) was significantly greater than that given in all other groups. Details of the 11 cases (none of which involved the two with uncertain diagnosis) are listed in Table II, in which the first relevant medication is given with the gestational age (days from first day of the last menstrual period). The conclusion drawn is that pyloric stenosis was associated with nausea and vomiting in pregnancy rather than with any specific drug. Whether the pyloric hyper-