Sandoz Stops Selling Controversial Drug to Postpartum Women
Aug. 19, 1994
WASHINGTON (AP) _ A major pharmaceutical company, under pressure from the government and consumer advocates, has agreed to stop selling women a controversial drug to help them stop lactating after childbirth.
Critics blamed the drug Parlodel for killing new mothers as well as causing heart attacks, strokes and seizures, and the Food and Drug Administration this week began preparing to block sales of the drug.
But Thursday, Sandoz Pharmaceuticals told the FDA it would voluntarily stop marketing Parlodel as a lactation suppressant.
However, Parlodel is an effective treatment for Parkinson's disease and several endocrine disorders, and will remain on the market for those patients.
In a statement from the company's East Hanover, N.J., headquarters, Sandoz said it hoped ''to end unwarranted criticism'' of Parlodel, which it insists is safe.
''It would be unfortunate if the medical benefits that this product provides'' to Parkinson's and endocrine patients ''are overshadowed by attacks on Parlodel's use'' by postpartum women, said Sandoz President Timothy Rothwell.
Although it is legal for obstetricians to prescribe any drug on the market, FDA pledged to warn them that safety questions prompted the Sandoz move. ''We will make sure that is clearly understood,'' said spokesman Jim O'Hara.
''The critical thing is for doctors to immediately stop using it,'' said Dr. Sidney Wolfe of Public Citizen.
The controversy began five years ago when the FDA declared lactation suppressants dangerous, and all makers of those drugs - except Sandoz - voluntarily withdrew them from the market.
The FDA at the time said it would force Sandoz to comply as well, but never did. Some 300,000 to 600,000 postpartum women use Parlodel every year, earning Sandoz over $12.5 million.
Tuesday, Public Citizen and the National Women's Health Network sued FDA, accusing regulators of dragging their feet over Parlodel. The suit cites FDA records that show 531 postpartum women reported serious adverse reactions to Parlodel since 1980, including 32 deaths, 36 strokes and 14 heart attacks.
And several women have sued over the drug, including a Kentucky stroke victim who last month was awarded $2.1 million.
Women who don't breast feed can experience very painful breast engorgement shortly after childbirth. The milk dries up on its own in about two weeks, and women often take painkillers, bind their breasts and use cold compresses in the meantime.
Sandoz contended that women should be able to choose a drug to help speed up the process and said it reviewed medical records of millions of patients to conclude the drug was safe.
FDA says that study was in fact inconclusive but acknowledged there is no definitive proof Parlodel is harmful. Still, it said it would block Parlodel sales because too few women benefit to take the risk. Doctors say the drug may have no effect on some 40 percent of the thousands who take it.