Serious adverse events in norplant users related to the food and drug administration's medWatch spontaneous reporting system

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It seems to me that the FDA has had a long history of viewing reversible methods of contraception along the lines that the glass is always half empty and never half full. How much nicer it would have been to say that there is no increased risk of stroke in Norplant users and we can all be reassured.

Letters

4 Columbia Driae Tampa, FL 33602

References 1. Wysowski DK, Green L. Serious advrrse events in Korplant reported to the Food and Drug Administration’s MedWatch taneous Reporting System. Obstet Gynecol 1995;85:538-42. 2. Robins M, Baum HM. liational survey of stroke/incidence. lYX1;12(suppI~:45-55.

SERIOUS NORIJLANT

ADVERSE EVENTS IN USERS RELATED

TO THE FOOD AND DRUG ADMINISTRATION’S SPONTANEOUS

MEDWATCH REPORTING

SYSTEM

I do not understand why Wysowski and Green’ state that I should inform patients who are considering Norplant as their contraceptive method of the possibility of stroke. As 1 understand the data in their article, hospitalization for stroke with Norplant may occur in 1:50,000 users. This compares with a 1992 estimated hospital discharge rate of first-listed diagnosis of stroke in reproductive age women of 1:4000 (personal communication: Elaine Wood, National Center for Health Statistics) and 1:25,000 for women younger than 35 years of age during 1975 and 1976.’ I recognize that the authors, who are employed by the Food and Drug Administration (FDA), have stated their own views, which are “not necessarily those of the FDA.” 1 also understand their equivocation regarding the FDA’s MedWatch Spontaneous Reporting System. However, neither makes me more sanguine about their belief that 1 now have a requirement to tell someone about an event that, by all indications in the medical literature, is rare.

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users SponStroke

We understand Chez’s reluctance to inform patients about a potential risk of stroke in Norplant users when that risk is based on case reports and on reporting rates lower than those expected for women of childbearing age. However, substantial underreporting of adverse drug reactions is likely and, therefore, reporting rates based on complete incidence may well be higher than those presented in our article. We suggest that physicians convey information about the potential risk of stroke when they ask Norplant candidates if they smoke cigarettes or have had any blood-clotting problems because the current labeling states that women who use Norplant should not smoke and that thrombophlebitis and thromboembolism are contraindications. Physicians could explain the following to their patients: 1) Oral contraceptive (OC) pills and cigarette smoking separately increase the risk of heart attacks and strokes. 2) When women smoke and take OC pills, there is a synergistic effect on the risks of developing heart attacks and strokes. 3) Because Norplant contains one of the hormones in OC pills, it is possible that the risks of heart attack and stroke are increased in Norplant users who smoke. It is also possible that Norplant by itself increases these risks. 4) Strokes and other clotting disorders have been reported in Norplant users, but the number of cases is relatively small. Alternatively, information on potential adverse reactions in Norplant users (including the mention of stroke and other clotting disorders) could be conveyed by asking the patient to read the Norplant patient package