Morning Sickness Drug May Return to US Market

W A S H I N G T O N, Oct. 10 -- Every year, millions of women undergo that rite of passage morning sickness. For thousands, it’s more than a nuisance of pregnancy, it’s a life-disrupting illness that, despite its common name, can last all day for weeks.

Yet doctors know amazingly little about why some women suffer somuch more than others—and while there are a few therapies, manypeople are reluctant to treat a condition considered, well, normal.

Now a Canadian company is working with the Food and DrugAdministration to bring back a morning-sickness drug thatobstetricians say was wrongly driven off the U.S. market 17 yearsago by hundreds of lawsuits claiming it caused birth defects.

The company already sells Canadians a generic version ofBendectin, a drug that experts say dozens of studies haveexonerated as very safe. And if sold here, obstetricians say itcould do more than treat some women—it could spread awarenessthat many suffer in silence.

Overwhelming Safety Data

The drug “would have a big role,” says Dr. T. Murphy Goodwin,the University of Southern California’s maternal-fetal medicinechief who co-chaired a recent National Institutes of Health meetingon better understanding and treatment of morning sickness.

“Paradoxically, the safety data is overwhelming” because theBendectin lawsuits of the late 1970s and early ’80s prompted somuch medical research, he explains. “It doesn’t cause birthdefects.”

“It would be wonderful” if the drug returned, adds Dr.Jennifer Niebyl, the University of Iowa’s obstetrics chief.

But many doctors aren’t waiting: Bendectin’s ingredients aresold here without a prescription—vitamin B6 and the antihistaminedoxylamine, found in Unisom—so they routinely tell nauseatedwomen how to mix up the right dose.

Some 80 percent of pregnant women experience at least somenausea and vomiting. About 1 percent have dangerously severevomiting called hyperemesis gravidarum that can requirehospitalization.