FDA To Consider Withdrawing Use Of Drug To Suppress Milk Production
RICHARD L. VERNACI
Sep. 02, 1993
WASHINGTON (AP) _ The Food and Drug Administration agreed Thursday to hold hearings on a consumer group's request it ban the use of a drug for treating postpartum breast soreness and engorgement in women who don't breast feed.
The FDA said it would move quickly on the request by Public Citizen's Health Research Group.
The group just hours earlier that the drug is ineffective, unnecessary and dangerous as a treatment for breast soreness. It accused Sandoz Pharmaceuticals Corp. of keeping it on the market simply to make money.
Sandoz rejected that contention.
FDA spokeswoman June Wyman said the FDA was moving ''expeditiously'' on holding a hearing on the issue. Such a proceeding would be the first step in a process that could compel the company to stop selling the drug for that use.
In a letter to FDA Commissioner David Kessler, Public Citizen said that since 1989 the government received 220 reports of adverse reactions to the drug by women under age 50. That included 13 deaths.
An FDA advisory panel four years ago recommended that the drug not be sold for that use an y more. The drug, which Sandoz markets under the brand name Parlodel, also is used to treat Parkinson's disease and other conditions.
The consumer group said it had no objections to the drug's other uses but complained that using it to halt milk production in women who have given birth exposed them to unnecessary risk.
The FDA asked the company voluntarily to stop promoting the drug for that use, and Sandoz refused. Public Citizen said the motive was money: The company makes about $12 million a year on sales of the drug for that use. About 300,000 women are prescribed the drug in a year.
''The FDA has inexcusably failed to follow through, abdicating its responsibility to assure that women are not given this unnecessary and potentially dangerous drug,'' Dr. Sidney Wolfe, director of the health research group, said in his letter to Kessler Thursday.
Sandoz spokesman Bill O'Donnell said the company is not profiteering on an unsafe drug and considers the health of its customers ''paramount.''
O'Donnell said no scientific analysis of the drug has linked it to health problems, and the company believes it is ''an effective and safe medication.''
O'Donnell said that the drug should not be used routinely to suppress milk production but the decision on when or whether to use it should be left up to women and their doctors.
Wolfe said if women do not breast feed after giving birth, their breasts are likely to become sore and leaky, but that condition goes away in a week or two. He suggested women could treat the discomfort with over-the-counter painkillers.