Sandoz Stops Parlodel Anti-Lactation Sales

Sandoz is voluntarily withdrawing the lactation suppression indication for its drug Parlodel (bromocriptine), five years after it was first requested to do so by the US Food and Drug Administration. The company still maintains that the drug is safe and effective when used in these patients, and the withdrawal does not affect the drug's other indications, Parkinson's disease, acromegaly and hyperprolactinemia-associated dysfunctions.

Sandoz' move came just two days after the FDA said that it would be proposing withdrawal of the lactation suppression indication (Marketletter August 22). There have been reports that women who chose not to breastfeed after childbirth, and received the drug to dry up their milk, may have suffered serious adverse reactions, including seizures, strokes and myocardial infarction. Several women have started litigation against Sandoz, seeking millions of dollars in damages after the alleged reactions.

According to the FDA, there have been 531 adverse reaction reports in women who have received Parlodel for the withdrawn indication, including 32 deaths (14 with strokes, five with heart attacks and eight with hypertensive crises). There has been pressure on Sandoz to withdraw the indication for some time, from the FDA and also from patient action groups. On August 16, Public Citizen's Health research group and the National Women's Health Network filed a petition with the aim of compelling the FDA to take measures towards withdrawing the lactation suppression indication, especially as the number of women who benefit from the treatment appears to be small (the FDA estimates around 10%).