Sandoz Faces Parlodel Lawsuits In USA

Sandoz Pharmaceuticals Corp is facing at least six lawsuits in the USA, seeking millions of dollars in damages over claims that its lactation suppressant Parlodel (bromocriptine mesylate) has caused serious side effects including strokes, heart attacks and seizures, in women who take the drug after pregnancy and childbirth. According to the Wall Street Journal, at least seven other suits have been settled out of court.

The Food and Drug Administration has initiated hearings on the drug's safety, but has been aware of possible problems with the drug for some time. In 1989, the FDA asked Sandoz to stop selling the drug voluntarily as a lactation suppressant. At that time, the FDA noted that for this indication, the risks of the drug outweigh its benefits. Parlodel is also indicated for treating the symptoms of Parkinson's disease and certain endocrine disorders, but these uses are not being challenged.

It is estimated that around 600,000 women who choose not to breastfeed each year receive Parlodel, which is the only approved lactation suppressant on the US market. Labeling for the drug makes reference to cases of these side effects and notes that the drug is contraindicated in hypertensive women.