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Parlodel no longer to be sold for lactation suppression - safety concerns lead to withdrawal of drug by Sandoz Pharmaceuticals Corp

FDA Consumer, Nov, 1994

A drug manufacturer voluntarily stopped marketing a product for lactation suppression last August, shortly after FDA initiated action to withdraw the drug's approval for that use because of safety concerns.

The agency had received numerous reports of deaths and other serious adverse reactions to Parlodel (bromocriptine) in women taking the drug to stop their milk production. The reports included 31 women suffering strokes--9 fatal--and 63 women with seizures. Of these, 40 percent reported no other cause of the event.

There were also seven reports of heart attack--one fatal--and 16 hospitalizations for headache, severe high blood pressure, and other conditions. Other reports of such reactions have appeared in the medical literature.

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Sandoz Pharmaceuticals Corp., which manufactures Parlodel, will continue to sell the drug for its other approved uses--to treat Parkinson's disease and acromegaly (enlargement of the bones of the nose, jaws, fingers, and toes caused by excess growth hormone). It is also approved for conditions associated with excess blood levels of the hormone prolactin, such as spontaneous flow of milk often accompanied by amenorrhea.

Parlodel no longer to be sold for lactation suppression - safety concerns lead to withdrawal of drug by Sandoz Pharmaceuticals Corp

FDA Consumer, Nov, 1994

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