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Return of the Morning Sickness Pill
C O N V E R S A T I O N S
W I T H
C O L L E A Q U E S
Return of the
Morning Sickness Pill Could Bendectin Be
Coming Back to Market?
Q
Is it true that the FDA is poised to approve the return of the “morning sickness” drug, Bendectin, to the market after the manufacturer pulled it from the shelves in 1983 for potentially causing deformities in babies? I I
A
At the time of this writing, the Los Angeles Times (December 7, 2000) and the Kaiser Daily Reproductive Health Report were both reporting that Merrell Dow Pharmaceuticals indeed may be able to once again market the drug. This is based on information from the FDA and new studies debunking fears regarding its effects on fetuses. I I
The Times reported that FDA officials claimed that it’s extremely rare for a drug to be removed from the market and then to be “exonerated and returned for its original purpose,” but added that the panic surrounding the drug may now have been unwarranted. While the manufacturer lost a number of lawsuits, which were later overturned on appeal, the incident is more noted for raising issues regarding “junk science” o r the practice of using unsubstantiated studies for efficacy. At issue within discussion about the drug is the fact that many so-called experts now say the drug doesn’t carry an elevated risk for either pregnant women or their unborn babies-either way the relative risk of a birth defect is approximately 4 percent. Still, scares associated with drugs like Bendectin bring to mind other drug approvals that proved to be devastating, such as was the case with thalidomide. Meantime, researchers and pregnant women alike are hesitant to undergo additional risks for drug testing unless conditions are so serious that the additional risk
22
AWHONN Lifelines
may be warranted o r more easily accepted. For now, Bendectin remains off-market. To track the possible reintroduction of this drug, or others, into the marketplace, surf to www.fda.gov.
Q.
I had recently heard that new guidelines on managing high blood pressure in pregnancy have been published for clinicians. Can you tell me about these new guidelines and where I might be able to obtain them? a
A
Absolutely! In fact, the National High Blood Pressure Education Program (NHBPEP) Coordinating Committee has issued the “2000 Working Group Report on High Pressure in Pregnancy,” which clarifies how to monitor and treat pregnant women who have hypertension prior to pregnancy and those who develop hypertension gestation. Hypertensive disorders occur in 6 to 8 percent of pregnancies and contribute significantly to serious complications for both the fetus and the mother, including severe fetal growth restriction and death (still-birth). Also, hypertensive disorders account for I I
nearly 15 percent of maternal deaths in the U.S., ranking second only to embolism as a leading cause. The new report covers the pathophysiology of hypertensive disorders in pregnancy, patient counseling for future pregnancies, and recommendations for future research. Treatments of women with related conditions, such as renal disease, are also addressed. The report expands upon the NHBPEP’s 1997 high blood pressure treatment guidelines and updates its 1990 report on hypertension in pregnancy. The report stresses the need for clinicians to differentiate between hypertension (blood pressure equal to or greater than 140 mm H g systolic o r 90 mm Hg diastolic) and hypertension with proteinuria (protein in the urine)-the strongest indicator of preeclampsia. The report also adds the category “gestational hypertension” to its classifications of hypertensive disorders of pregnancy. This term is used on an interim basis to describe women with elevated blood pressure that first appears during midpregnancy without proteinuria; the diagnosis is updated postpartum to either transient hypertension of pregnancy (blood pressure has returned to normal) or chronic hypertension (blood pressure remains elevated). The report updates a recommendation on measuring diastolic blood pressure during pregnancy, suggesting that clinicians use K5 (disappearance)
Volume 5, Issue I
February/March 2001
A W H O N N Lifelines
23
W I T H
C O L L E A Q U E S
Return of the
Morning Sickness Pill Could Bendectin Be
Coming Back to Market?
Q
Is it true that the FDA is poised to approve the return of the “morning sickness” drug, Bendectin, to the market after the manufacturer pulled it from the shelves in 1983 for potentially causing deformities in babies? I I
A
At the time of this writing, the Los Angeles Times (December 7, 2000) and the Kaiser Daily Reproductive Health Report were both reporting that Merrell Dow Pharmaceuticals indeed may be able to once again market the drug. This is based on information from the FDA and new studies debunking fears regarding its effects on fetuses. I I
The Times reported that FDA officials claimed that it’s extremely rare for a drug to be removed from the market and then to be “exonerated and returned for its original purpose,” but added that the panic surrounding the drug may now have been unwarranted. While the manufacturer lost a number of lawsuits, which were later overturned on appeal, the incident is more noted for raising issues regarding “junk science” o r the practice of using unsubstantiated studies for efficacy. At issue within discussion about the drug is the fact that many so-called experts now say the drug doesn’t carry an elevated risk for either pregnant women or their unborn babies-either way the relative risk of a birth defect is approximately 4 percent. Still, scares associated with drugs like Bendectin bring to mind other drug approvals that proved to be devastating, such as was the case with thalidomide. Meantime, researchers and pregnant women alike are hesitant to undergo additional risks for drug testing unless conditions are so serious that the additional risk
22
AWHONN Lifelines
may be warranted o r more easily accepted. For now, Bendectin remains off-market. To track the possible reintroduction of this drug, or others, into the marketplace, surf to www.fda.gov.
Q.
I had recently heard that new guidelines on managing high blood pressure in pregnancy have been published for clinicians. Can you tell me about these new guidelines and where I might be able to obtain them? a
A
Absolutely! In fact, the National High Blood Pressure Education Program (NHBPEP) Coordinating Committee has issued the “2000 Working Group Report on High Pressure in Pregnancy,” which clarifies how to monitor and treat pregnant women who have hypertension prior to pregnancy and those who develop hypertension gestation. Hypertensive disorders occur in 6 to 8 percent of pregnancies and contribute significantly to serious complications for both the fetus and the mother, including severe fetal growth restriction and death (still-birth). Also, hypertensive disorders account for I I
nearly 15 percent of maternal deaths in the U.S., ranking second only to embolism as a leading cause. The new report covers the pathophysiology of hypertensive disorders in pregnancy, patient counseling for future pregnancies, and recommendations for future research. Treatments of women with related conditions, such as renal disease, are also addressed. The report expands upon the NHBPEP’s 1997 high blood pressure treatment guidelines and updates its 1990 report on hypertension in pregnancy. The report stresses the need for clinicians to differentiate between hypertension (blood pressure equal to or greater than 140 mm H g systolic o r 90 mm Hg diastolic) and hypertension with proteinuria (protein in the urine)-the strongest indicator of preeclampsia. The report also adds the category “gestational hypertension” to its classifications of hypertensive disorders of pregnancy. This term is used on an interim basis to describe women with elevated blood pressure that first appears during midpregnancy without proteinuria; the diagnosis is updated postpartum to either transient hypertension of pregnancy (blood pressure has returned to normal) or chronic hypertension (blood pressure remains elevated). The report updates a recommendation on measuring diastolic blood pressure during pregnancy, suggesting that clinicians use K5 (disappearance)
Volume 5, Issue I
February/March 2001
A W H O N N Lifelines
23