NurseWeek

Drug revived to fight morning sickness

By Astara March
Health24News
October 11, 2000


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Washington (H24N). Bendectin, a popular anti-morning sickness drug that was taken by millions of pregnant women in the United States and Europe from 1956 to the early 1980s when it was accused of causing birth defects, has now been declared safe by the Food and Drug Administration (FDA).

Bendectin was the subject of hundreds of lawsuits in the late 1970s and early 80s by women whose infants were born without fingers or missing bones in their limbs. Although appeals courts ruled in the manufacturer’s favor, the drug was taken off the market by its maker, Merrill Dow Pharmaceuticals, in 1983 because litigation costs were getting too high.

After 17 years of medical research, the FDA has again declared the drug safe. Canada’s Duchesnay Inc., which has marketed a generic version of Bendectin called Diclectin in Canada since 1975, has asked the FDA for permission to market Diclectin in the United States. If the company can prove that the drugs are chemically identical, Duchesnay will be allowed to market Diclectin.

Ironically, it was the lawsuits that have led to Bendectin’s return. The furor inspired so much medical research that the safety evidence is overwhelming, according to T. Murphy Goodwin, MD, chief of maternal-fetal medicine at the University of Southern California and co-chair of a recent meeting at the National Institutes of Health on understanding and treating morning sickness. Speaking to USA Today Health Oct. 9, Goodwin was glad to welcome the drug back, predicting that it "would have a big role" in obstetrical practice in the future.

Morning sickness is thought to be caused by the increased levels of hormones needed to sustain a healthy pregnancy. Progesterone, particularly, is known to cause digestive upsets. It causes nausea and vomiting that are usually most pronounced in the morning when the stomach is emptiest, and symptoms can range from mild to debilitating enough to warrant hospitalization.

The FDA has not yet issued a statement on when Diclectin will be available in the United States, nor has Merrill Dow Pharmaceuticals indicated whether it will manufacture Bendectin again.