SANDOZ PARLODEL IS EFFECTIVE IN LACTATION SUPPRESSION, FDA's

Executive Summary

SANDOZ PARLODEL IS EFFECTIVE IN LACTATION SUPPRESSION, FDA's Fertility & Maternal Health Drugs Advisory Committee agreed at its June 2 meeting. The committee, which met to review the validity of the indication and consider adverse reaction reports, postponed an in-depth discussion of safety considerations related to Parlodel (bromocritpine) pending further epidemiological study. Deferring to the 1980 FDA approval of the lactation suppression indication for Parlodel, committee member James Schlesselman, PhD, remarked: "There is no reason for me to doubt the previous statement of the FDA" on the matter of efficacy. The committee voted five to zero in favor of preserving the indication. "Why give a drug for two weeks for a condition which without intervention basically resolves in two to three days?" FDA Fertility & Maternal Health Group Medical Officer Vanja Ragavan, MD, asked. She pointed out that while Parlodel is effective during the 14 days of prescribed use, a rebound effect of lactation has been reported in some studies of up to 50% of the non-breast-feeding women upon cessation of Parlodel therapy. The committee also noted reports that Parlodel has been associated with strokes, myocardial infarctions, seizures, hypertension and psychosis. Since the drug's approval in 1980, Sandoz has received approximately 50 adverse reaction reports, including 2 deaths, from women who took Parlodel for lactation suppression. The panel agreed unanimously that "there is insufficient data to state a causal relationship between Parlodel and stroke and/or seizure, but there is sufficient data to suggest awaiting the results of the analytic studies which should be forthcoming." Sandoz said its epidemiological study assessing the risks of Parlodel will be complete in September 1988. Since its initial marketing, the drug has undergone more restrictive labeling changes in 1983 and again in 1985, the result of FDA concern with adverse reaction reports. The Sandoz study, being conducted by Epidemiolgical Resources Inc. is a case control study analyzing 10 cases of stroke and 38 cases of seizure from three computerized data bases in the US and Canada. Some committee members questioned the accuracy of such a small study. ERI Senior Epidemiologist Kenneth Rothman, PhD, maintained that a larger study was not possible given FDA's request to expedite the matter.