Serious adverse events in Norplant users related to the Food and Drug Administration's MedWatch Spontaneous Reporting System.

Abstract

OBJECTIVE: To describe serious adverse events in Norplant users from reports submitted to the Food and Drug Administration's (FDA) MedWatch Spontaneous Reporting System. METHODS: Reports of certain serious adverse events in Norplant users in the United States from February 1991 to December 1993 were reviewed and analyzed. RESULTS: From the introduction of Norplant in the United States in February 1991 to December 1993, the FDA received reports of 24 women hospitalized for infections at the insertion site, 14 hospitalized or disabled because of difficulties removing the capsules, 14 hospitalized for stroke, three for thrombotic thrombocytopenia purpura, six for thrombocytopenia, and 39 for pseudotumor cerebri. The comparison of reported rates with expected rates and the relationship of some of these disorders with oral contraceptives raises the suspicion of a causal association with Norplant. CONCLUSIONS: The FDA has received reports of hospitalization or disability for infections, capsule removal difficulties, stroke, thrombotic thrombocytopenia purpura, thrombocytopenia, and pseudotumor cerebri in Norplant users. Health care professionals need to be trained in Norplant insertion and removal to ensure the proper technique. Studies are needed to determine if stroke, thrombocytopenia, and pseudotumor cerebri are causally related to Norplant use.