Worldwide production of Bendectin, for a quarter century the only medicine approved by the Food and Drug Administration for the "morning sickness" of early pregnancy, has been ended "for compelling nonmedical reasons," the manufacturer said in a surprise announcement yesterday.
"The burdens of marketing Bendectin have become just too heavy," David B. Sharrock, president of Merrell Dow Pharmaceuticals, U.S.A., said. The annual cost of premiums for insurance against lawsuits by Bendectin users has topped $10 million, or only about $3 million less than the revenues from U.S. sales in 1982, Sharrock told a news conference at the Washington Hotel.
The Cincinnati firm acted 13 days after a D.C. Superior Court jury awarded $750,000 to the family of Mary Oxendine, 12, who was born with serious deformities of the right arm and hand after her mother had taken Bendectin.
The family also is seeking $1 million in punitive damages. Merrell is appealing the compensatory award, which was based on alleged negligence in dealing with animal and human data on birth defects.
The company, which Dow Chemical bought from Richardson-Merrell Inc. in 1981, faces about 300 other lawsuits in federal and state courts. The drug is "a victim of these litigious times," Sharrock said. Despite two "extraordinary price increases" since March, 1982, he said, "we anticipate that we will lose money on Bendectin in 1983."
Sharrock and Dr. Charles E. Flowers Jr. of the University of Alabama, who is vice president of the American College of Obstetricians and Gynecologists, cited numerous studies in rejecting evidence that the drug has caused any of a wide variety of birth defects.
Some of the studies favorable to Bendectin have been faulted by FDA scientists and others, but Flowers termed the evidence of hazard "a small molehill" and said that Bendectin has been thoroughly tested.
"It is our foremost concern that patients who have taken or are taking Bendectin during a current pregnancy should not be alarmed by our action," Sharrock said.
Added Flowers: "This drug is safe," and women using it should know that "there is no danger to your unborn fetus."
Both urged Bendectin users not to be panicked into seeking abortions. That plea was endorsed by the Public Citizen Health Research Group (HRG), which petitioned the FDA in 1981 to stop sales of the drug.
Bendectin was available in this country only by prescription but was sometimes sold over the counter in other countries under such names as Debendox, Lenotan and Merbental.
The company estimates that 33 million women received the drug.
Sharrock said Merrell has set up a toll-free information number for physicians and pharmacists and is advising them that supplies of the drug will be sufficient for present users.
Women not now getting Bendectin should not start to use it because no new shipments will be made, he said.
The HRG said Merrell was "irresponsible" to recommend continued use by anyone.
Flowers was asked if Merrell was paying him to attend yesterday's news conference.
"If Merrell would like to pay me, I would be glad to accept it," he said.
Flowers appeared for Merrell at an FDA advisory panel hearing on Bendectin in 1980. He was paid $2,000 for his appearance, company records show.
The panel found no cause-effect relationship between Bendectin and birth defects but cited a "residual uncertainty" about some types of defects.
Since then, Sharrock said, inconclusive research on birth defects has been reported, causing some women to be "frightened by publicity."
By contrast, the HRG said that "hundreds of thousands of pregnant women and their unborn children will be spared the risk of exposure to this questionably effective and unsafe drug."
The group, founded by consumer advocate Ralph Nader, also protested that for about a year, Merrell's labeling for doctors--but not its information sheet for users--has warned that Bendectin had been found to cause a serious birth defect called diphragmatic hernia in animals.
Rep. Doug Walgren (D-Pa.), Bendectin's leading critic in Congress, said "it's about time" Merrell stopped making the drug.
Renewing his longstanding criticism of the FDA, he said its performance has been "dismally lacking in the assurance of safety which the public assumes" from its approval of a medicine.
In 1956, Merrell applied for permission to sell Bendectin without submitting animal test data on possible toxicity or peril to the fetus, and with limited human tests focusing mainly on the short-term safety of the woman and the drug's efficacy.
The FDA approved the application four weeks later.
A panel of plaintiffs' counsel praised Merrell's action yesterday but expressed disappointment that the company is not recalling existing supplies of Bendectin.
The current FDA-approved labeling recommends Bendectin only in cases of severe nausea and vomiting that is unresponsive to conservative therapy, such as hot or cold drinks and dry toast or crackers.