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In 1983, the morning sickness drug Bendectin was withdrawn from
the market by the drug's manufacturer, Merrell Dow, due to a barrage
of lawsuits claiming that it caused birth defects.
The drug's reversal of fortune was swift. In
1980, just 3 years prior, it is estimated that 10 to 20 percent
of pregnant women in the United States were taking Bendectin.
Now, a small privately held Canadian company, Duchesnay Inc., is
working with the Food and Drug Administration (FDA) to gain permission
to market a generic version of Bendectin, which it calls Diclectin.
The company is already selling the drug, its only product, in Canada,
labeling and marketing it specifically for pregnant women.
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The company says, and medical experts agree, that the many
studies done have failed to find that Bendectin poses any dangers
to pregnant women or their fetuses.
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The FDA says that since Bendectin was withdrawn by its maker,
and was not withdrawn for reasons of safety or efficacy, it
might not be difficult to bring it back.
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According to the FDA, all Duchesnay has to do is to show that
its generic Bendectin is chemically the same as the original
drug. No clinical studies or research are required.
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Bendectin is the only drug withdrawn from the US market solely
because of litigation, said Jeffrey Trewhitt, a spokesman for
the Pharmaceutical Research and Manufacturers of America.
Women who took Bendectin and had babies with birth defects, found
it hard to believe scientists who said that such things simply happen
by chance and that the millions of women who took Bendectin had
no more children with birth defects than those who did not take
the drug.
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One out of every 2,000 American babies born each year has a
limb defect and about 2.5 percent of babies have some form of
birth defect.
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Currently, Duchesnay sells 70,000 bottles of Diclectin annually
in Canada, each one containing 100 pills.
According to Dr. Anthony Scialli, a professor of obstetrics and
gynecology at Georgetown University School of Medicine, "There's
a huge amount of safety data on Bendectin," Dr. Scialli said.
"It was the best studied medication in pregnancy of all time
- not just for nausea and vomiting, but the best studied, period."
When Bendectin's maker, Merrell Dow, removed the drug from the
market, it said it was doing so simply because the cost of defending
itself against an avalanche of lawsuits was too great, despite the
fact that the company claims that it never ultimately lost a single
case.
Some legal experts say that due to its prior history in the courts,
that Duchesnay may be the drug manufacturer least likely to be sued,
since many judges have made it clear that they will no longer allow
Bendectin cases in their courts.
Barry Nace, a Washington lawyer who has represented close to 200
Bendectin families, said the lawsuits were generally hopeless. "You
might say that this is the safest drug in terms of litigation,"
Mr. Nace said. "It's judicial door-slamming - they make it
so hard for plaintiffs to win these cases that it almost doesn't
matter what you say."
As for the drug's safety, Mr. Nace is still unconvinced, saying,
"In my mind, there is no question that Bendectin causes birth
defects."
Dr. Charles Lockwood, chairman of the department of obstetrics
and gynecology at New York University School of Medicine, said he
sometimes prescribes the aggressive psychoactive drug Reglan for
women with nausea and vomiting. The drug controls nausea but also
makes women very drowsy. "The amount you have to give to have
an effect tends to make them sleepy all day long," he said.
Some doctors say they tell women essentially
to make their own Bendectin, by simply taking an antihistamine and
vitamin B6, which are available over the counter.
One doctor says he tells women to take one vitamin B6 pill in
the morning and two at night and to take a half pill of the antihistamine
Unisom twice a day.
The NY Times' Gina Kolata interviewed a mother who claims that
the Bendectin-like combination was a lifesaver for her during her
first pregnancy, when nothing else helped. She even took the antidepressant
Zoloft intravenously, with no results.
Last year, when she became pregnant again, the mother did not want
to wait before taking the antihistamine and vitamin B6. She told
her doctors "'Give it to me', the minute I started throwing
up."
New York Times September 26,
2000
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