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Sandoz retreats.

SHORTLY AFTER PUBLIC CITIZEN filed an August 1994 lawsuit against the Food and Drug Administration (FDA) to force the federal agency to ban Sandoz Pharmaceuticals Corporation's widely-used drug Parlodel (bromocriptine mesylate), the company advised the FDA that it was withdrawing the indication of the drug for post-partum lactation suppression from the U.S. market.

Timothy Rothwell, president and chief executive officer of Sandoz, says the decision was intended to end unwarranted criticism over the indication. "Parlodel is widely used to treat Parkinson's Disease and endocrine disorders," Rothwell says. "It would be unfortunate if the medical benefits that this product provides in those areas are overshadowed by attacks on Parlodel's use in the post-partum indication that have no scientific foundation."

Public Citizen argued that a ban was needed because of "an ever-increasing number of serious injures such as strokes and heart attacks including many deaths in otherwise healthy young women associated with the use of Parlodel." Public Citizen said that from Parlodel's approval as a lactation suppressing drug in 1980 to June 1994, there have been 531 adverse reaction reports in women aged 15 through 45 who have used the drug, including 32 deaths.

"Although Sandoz, the manufacturer of Parlodel, must bear primary responsibility for this tragedy," wrote Public Citizen Heath Research Group Director Dr. Sidney Wolfe, "the FDA has clearly been complicit in allowing these deaths and injuries to continue."

But Rothwell said that the safety of Parlodel as a lactation suppression product has been demonstrated by independent studies and a review of data from millions of patients. "The post-partum lactation indication has never generated significant revenues for Sandoz, but we felt that women who needed this product should, in consultation with their doctors, have the choice available," Rothwell said.

Each year at least 300,000 women take Parlodel for treatment of post-partum breast engorgement, at a return to Sandoz of approximately $12.5 million a year.
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Title Annotation:Sandoz Pharmaceuticals Corp.
Publication:Multinational Monitor
Date:Sep 1, 1994
Words:317
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