Drug manufacturer stops marketing Parlodel to new mothers.

Under a barrage of consumer criticism and a lawsuit, the manufacturer of Parlodel said it will no longer market the drug as a lactation suppresant. The drug has been blamed for the deaths of at least 32 new mothers and medical problems in hundreds of women since it received U.S. Food and Drug Administration (FDA) approval in 1980.

The August 18 announcement comes five years after the FDA first asked Swissbased Sandoz Pharmaceuticals Corp. to voluntarily stop marketing the drug. Two days before the announcement, Public Citizen Health Research Group and the National Women's Health Network filed a lawsuit in federal court in Washington, D.C., seeking to bar postpartum use of the drug, generically known as bromocryptine mesylate. (In re Public Citizen Health Research Group, No. 94-1565 (D.C. Cir. filed Aug. 16, 1994).)

"More has happened in the past week than in the past five or six years with Parlodel," Sidney Wolfe, director of the Public Citizen consumer health group, said following Sandoz's announcement. "There's nothing like a lawsuit to get things moving."

Parlodel dries up breast milk in women who decide not to nurse their newborns. This suppression process occurs naturally but can be very uncomfortable due to breast engorgement. Some doctors prescribe the drug for about two weeks shortly after childbirth to alleviate the mother's pain.

In their lawsuit, the consumer groups quoted FDA reports from 1980 to June 1994 finding that 531 adverse reactions, such as heart attacks, seizures, and strokes, have occurred in postpartum women using Parlodel. Of that number, 32 deaths were reported. Parlodel is prescribed to as many as 600,000 women a year, according to Sandoz.

In 1989, Sandoz refused the FDA request to stop marketing the drug for lactation suppression, and it still contends the product is safe and effective. Timothy Rothwell, president and chief executive officer of the company, said he announced the decision to "end unwarranted criticism" over Parlodel's postpartum use.

The drug, howeve,r will continue to be prescribed to treat Parkinson's disease, overactive pituitary glands, and other disorders, according to Rothwell. Consumer complaints were not directed toward those uses.

A few days after its suit was filed, Public Citizen announced the creation of a clearinghouse of information for attorneys seeking data on the drug and related lawsuits.

For information, write to Wolfe at 2000 P St., N.W., Washington, DC 20036.