Obstetrician-gynecologists eager to see return of morning sickness drug Bendectin

A Canadian firm may bring back a version of Bendectin. While doctors are pleased, consumer advocates are skeptical about safety.

By Victoria Stagg Elliott, amednews staff. Nov. 6, 2000.

Doctors who care for pregnant women are expressing relief that a version of Bendectin, an anti-morning sickness drug withdrawn from the U.S. market in 1983, soon may be available again. The drug was pulled from pharmacy shelves by its manufacturer Merrell Dow Pharmaceuticals because it was associated with mounting lawsuits alleging its liability in connection with birth defects.

"The disappearance of Bendectin was a terrible tragedy based on very bad science," said David Grimes, MD, clinical professor at the University of North Carolina School of Medicine in Chapel Hill. "In the past I used it widely, as did all of us. It was an extremely popular drug. It worked for a common and very devastating problem. The fact that it disappeared from the market is a travesty of epidemiology."

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The drug, generically known as doxylamine succinate, continued to be available in Canada under the name Diclectin. The Canadian manufacturer, Duchesnay Inc., based in Laval, Quebec, recently sought Food and Drug Administration approval to sell the drug in the United States. The FDA has asked the firm to prove that Diclectin is chemically the same as Bendectin. This process is under way.

But consumer advocates remain skeptical. "Thalidomide is back, too, but not for morning sickness," said Arthur Levin, MPH, director of the national nonprofit Center for Medical Consumers in New York. "The question really is, how good is the evidence that it is safe? ... Does the benefit outweigh the risk? Do you really want to put women at risk to treat morning sickness?"

Lacking other options

Few physicians would disagree that the majority of pregnant women experience some morning sickness. There also have been complaints that the withdrawal of Bendectin left doctors with few treatment options.

"Women are hospitalized often for this because they're so dehydrated," Dr. Grimes said. "It's a real medical issue for which we have very poor management choices."

For example, the first-line treatment usually recommends dietary changes, such as eating small bland meals. Some physicians also suggest that patients take vitamin B6 supplements, one of the original ingredients in Bendectin. Acupressure bands to ward off motion sickness also have offered some relief. In addition, some physicians instruct their patients on how to mix a homemade version of Bendectin using B6 and doxylamine, an antihistamine available in over-the-counter sleep aids.

But if these solutions don't work, doctors say they often end up prescribing anti-nausea medications, although none now on the market has been specifically tested on pregnant women. "So, we're jumping from the frying pan into the fire because Bendectin, which had been studied extensively in pregnant women and found safe, was pulled from the market because of legal problems," said Michael Greene, MD, director of maternal fetal medicine at Massachusetts General Hospital in Boston. He is also chair of the FDA's advisory committee on reproductive drugs. "What that leaves us with is lots of other drugs that have never been studied in pregnant women that we're just forced to use." And among those currently available, some are very expensive, costing as much as $25 a pill. Still, the medications are sometimes a necessity. "That's the only thing that kept my wife from ending up in the hospital," said Bradley Goldberg, MD, an ob-gyn with the Coffee Clinic in Douglas, Ga.

Morning sickness is a poorly understood condition, but the possible return of Bendectin is one sign of increasing interest in the problem. The first international conference on the ailment was held two years ago. The National Institute of Child Health and Human Development recently held a two-day meeting to review the latest studies and debate solutions.

The most controversial area of current research focuses on its evolutionary origins -- questioning whether mild to moderate morning sickness should be treated at all.

Paul W. Sherman, PhD, an evolutionary biology professor at Cornell University in Ithaca, N.Y., published a study this summer concluding that morning sickness was Mother Nature's way of protecting mothers and their unborn babies. There was no question that women with severe morning sickness should be treated, but there is less certainty about mild or moderate cases, he said.

"If you suppress the symptoms, what happens?" Dr. Sherman said. "Well, that would presumably leave the mother and the offspring more vulnerable to parasites and pathogens in food. But our food supply in this country -- due to the use of refrigeration and preservatives -- is probably much safer than the food supply [was] when this phenomenon evolved. It's not an easy answer."

But his research also indicated that morning sickness may still be necessary. "Women who do experience nausea and vomiting in pregnancy have fewer miscarriages. That suggests that the phenomenon still has some use," he said.