Morning Sickness Drug May Return to US Market

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 so much more than others—and while there are a few therapies, many people are reluctant to treat a condition considered, well, normal.

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

The company already sells Canadians a generic version of Bendectin, a drug that experts say dozens of studies have exonerated as very safe. And if sold here, obstetricians say it could do more than treat some women—it could spread awareness that 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 medicine chief who co-chaired a recent National Institutes of Health meeting on better understanding and treatment of morning sickness.

“Paradoxically, the safety data is overwhelming” because the Bendectin lawsuits of the late 1970s and early ’80s prompted so much medical research, he explains. “It doesn’t cause birth defects.”

“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 are sold here without a prescription—vitamin B6 and the antihistamine doxylamine, found in Unisom—so they routinely tell nauseated women how to mix up the right dose.

Some 80 percent of pregnant women experience at least some nausea and vomiting. About 1 percent have dangerously severe vomiting called hyperemesis gravidarum that can require hospitalization.

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

Hormone Surge Link?

The surge of hormones necessary for pregnancy is believed the underlying cause. Indeed, morning sickness has been linked to less miscarriage presumably for that reason.

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

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

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

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

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

Meanwhile, Americans do have some options. Doctors’ first advice: Eat protein snacks before bed. Nibble crackers before getting out of bed. Eat frequent small meals. Avoid nausea-triggering odors. Try acupressure wristbands that help some people fight seasickness.

For worse cases, Niebyl advises taking half a Unisom tablet plus 10 milligrams of vitamin B6, almost the same medication dose as Bendectin. Obstetricians also try B6 alone and certain other antinausea medicines like promethazine, although none has as much safety 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 women they have to suffer.”