Morning Sickness Drug May Return to US Market

W A S H I N G T O N, Oct. 10, 2000 -- 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.

Goodwin says another third are nauseated enough to disrupt dailyactivities, nausea so incapacitating it’s sometimes compared tothat caused by chemotherapy. Yet it’s often trivialized, saysGoodwin, who has seen health workers accuse sufferers of “beingcrazy” or not wanting the baby.

Hormone Surge Link?

The surge of hormones necessary for pregnancy is believed theunderlying cause. Indeed, morning sickness has been linked to lessmiscarriage presumably for that reason.

But nobody knows just why hormones cause nausea. One trendy,although not widely accepted, theory contends it’s evolution-causedprotection from food toxins. Nor does anyone know why some womenget sicker than others. It’s so baffling that the NIH last monthteamed obstetricians with experts on chemotherapy, motion sicknessand other stomach-churning disorders to hunt new clues.

Bendectin was once a wildly popular prescription treatment. Soldsince 1956, 33 million women took it here and abroad.

Then women whose babies were born missing fingers or bones intheir limbs sued. While appeals courts ruled in the manufacturer’sfavor—and a U.S. Supreme Court decision ultimately would renderfuture suits unlikely—Merrill Dow Pharmaceuticals declared thelitigation cost too high and quit making Bendectin in 1983.

What was happening? Three out of every 100 newborns has a majordefect whether their mothers took any drug during pregnancy or not,Goodwin says. Studies eventually concluded Bendectin didn’tincrease that baseline risk.

While some lawyers and families still blame Bendectin, the FDAreexamined the data last year and again called the drug safe -opening the door for Canada’s Duchesnay Inc. to seek approval tosell its generic Bendectin here. FDA’s main requirement: ProveDuchesnay’s drug, named Diclectin and sold in Canada since 1975, ischemically the same as Bendectin, which the company is working todo.

Meanwhile, Americans do have some options. Doctors’ firstadvice: Eat protein snacks before bed. Nibble crackers beforegetting out of bed. Eat frequent small meals. Avoidnausea-triggering odors. Try acupressure wristbands that help somepeople fight seasickness.

For worse cases, Niebyl advises taking half a Unisom tablet plus10 milligrams of vitamin B6, almost the same medication dose asBendectin. Obstetricians also try B6 alone and certain otherantinausea medicines like promethazine, although none has as muchsafety data as Bendectin, she says.

Key is for more doctors, and patients, to consider treatment,says Georgetown University’s Dr. Anthony Scialli. “Interpreting(morning sickness) as normal should not be equated as telling womenthey have to suffer.”