November 26, 2024
BANGOR DAILY NEWS (BANGOR, MAINE

FDA sued over drug to suppress lactation

WASHINGTON — A drug that suppresses lactation after childbirth is killing and disabling healthy women and the government is ignoring the problem, a consumer advocate contended in a lawsuit Tuesday.

The Food and Drug Administration said five years ago that lactation suppressants were dangerous, and every manufacturer but one — Sandoz Pharmaceuticals — voluntarily took their drugs off the market.

FDA has said it would force Sandoz to comply but never has, and 300,000 to 600,000 U.S. women continue to take the drug Parlodel every year.

Public Citizen’s Health Research Group sued FDA asking the U.S. Court of Appeals to force the agency to act.

“You and the FDA have recklessly allowed Sandoz to continue selling this drug, which keeps killing and maiming more and more women,” Public Citizen’s Sidney Wolfe wrote FDA Commissioner David Kessler.

At least 19 women have died and numerous others have suffered strokes, heart attacks and seizures after taking Parlodel since FDA began wrestling with the drug in 1989, Wolfe said.

FDA soon will issue a legal notice to Sandoz that it will block use of Parlodel for lactation suppression, said agency spokesman Don McLearn.

“We are doing it as we now speak,” he said, although he didn’t provide a date.

The drug would still be available for people with Parkinson’s disease and a few other disorders, so obstetricians would still have access to it.

Dr. Donnica Moore of Sandoz said, “We stand behind the safety of this drug 100 percent.”

Women who don’t breast feed 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.

But Sandoz and many obstetricians say women should be free to choose to take a drug to speed the process.

“We don’t need people like Sidney Wolfe, who just want women to bite the bullet and deal with two weeks of pain,” said Moore, who recalled pain so intense she couldn’t lift her new baby. “When men have a vasectomy, an office procedure that takes 10 minutes, they’re on pain medication.”

Sandoz earns at least $12.5 million a year from postpartum women.

But at least six lawsuits have been filed against Parlodel. Last month, a jury awarded $2.1 million to a Kentucky women who suffered a severe stroke after taking the drug in 1988.

Wolfe said FDA records show that 531 women have reported serious adverse reactions to Parlodel since 1980, including 32 deaths, 36 strokes and 14 heart attacks.


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