Sandoz Pharmaceuticals said Thursday that it will stop selling its Parlodel drug for the purpose of suppressing lactose in women who have just given birth.
Used widely for treating symptoms of Parkinson's disease and various endocrine disorders, Parlodel had been blamed in consumer lawsuits for fatal strokes and seizures in women who took it after giving birth.
With pressure mounting from consumer advocates, Sandoz agreed to end sales for lactose suppression one day after the Food and Drug Administration said it would seek to withdraw approval of Parlodel for that use.
Parlodel will remain on the market for its other approved uses.
The controversy erupted just three months after Sandoz bought Gerber Products Co., the nation's leading maker of baby food, for $3.7 billion. But Sandoz discounted speculation that its decision on Parlodel was partly due to a desire by the company to avoid an unfavorable reputation among the baby food-buying population.
Even as it announced its action, Sandoz officials--and some doctors--defended Parlodel as a safe and effective treatment for pain and engorgement experienced by some 600,000 women each year who cannot or choose not to breast-feed after childbirth.
"What we're basically doing here is making a business decision," said Larry Bauer, a spokesman for Sandoz Pharmaceuticals in East Hanover, N.J., a unit of Swiss-based Sandoz Ltd.
"There is no scientific evidence (that Parlodel is unsafe) and there will not be," he said, "just as there is no causal relationship that driving a Chevy or a Ford (after childbirth) increases the risks of these same kind of problems."
Physicians can legally prescribe any drug on the market. But given the safety questions with Parlodel, doctors would face a considerable liability risk if they continued to prescribe it for lactation suppression, doctors said.
On Tuesday, two consumer watchdog groups, the Public Citizen Health Research Group and the National Women's Health Network, filed a lawsuit in federal appeals court in Washington, accusing the FDA of "unreasonable delay" in acting to block use of Parlodel for lactose suppression.
The FDA said five years ago that lactation suppressants posed a health risk and asked companies to stop marketing them. Every manufacturer except Sandoz voluntarily pulled their drugs off the market. But consumer advocates said the FDA never acted--until Wednesday--to force Sandoz to comply with its request.
Dr. Sidney Wolfe, head of the health research group of Public Citizen, said his group repeatedly called on the FDA to take action on Parlodel. "We finally decided to sue them because they don't seem to understand anything other than that," he said.
The FDA said it is aware of 31 strokes, seven heart attacks and 63 seizures by women who took bromocriptine--the generic name for Parlodel. Ten of the strokes and heart attacks were fatal. Another 16 patients were hospitalized for severe hypertension, headaches or other reactions, the agency said.
But Public Citizen said its review of FDA records from 1980 through mid-1994 showed 32 fatalities associated with the use of Parlodel.
With Sandoz's withdrawal of Parlodel for lactation suppression, there is no prescription drug available for new mothers to alleviate pain related to not breast-feeding.
"In situations like this, women have fewer choices," said Dr. Mary Lake Polan, chairwoman of Stanford University's gynecology and obstetrics department. "Parlodel is clearly (effective) and I think it's safe."
But Dr. Naomi Baumslag, a professor at Georgetown University Medical School and an expert in breast-feeding issues, said the drug "should have been taken off the market in 1985. It's outrageous."
Baumslag recommended other methods for reducing discomfort from lactation, including binding the breasts by wearing a tight bra, ice packs, hot baths or certain over-the-counter pain relievers.
Parlodel sales for lactose suppression totaled about $12 million annually, Sandoz's Bauer said. The firm last year had worldwide revenue of $10.3 billion.
Sandoz recently settled lawsuits involving the drug with seven plaintiffs, although at least six more cases are pending. Last month, the company was ordered to pay $2 million to a woman who suffered a stroke while taking the drug.