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| |  Norplant Users Urged to Use Back-up Contraception MADISON, NJ -- September 13, 2000 -- Wyeth-Ayerst Laboratories, a division of American Home Products Corporation, has sent an update to health care providers regarding the Norplant® System (levonorgestrel implants), a five-year contraceptive. Women who have received Norplant System from lots distributed on or after October 20, 1999 are advised to use a back-up, barrier or other non-hormonal method of contraception because the contraceptive effectiveness of these specified lots cannot be assured at this time. Laboratory stability testing showed the product from certain specified lots may not release enough of the hormone, levonorgestrel, to deliver effective, ongoing contraception. This is the second letter to inform health care providers about stability testing results involving seven specific manufacturing lots of the Norplant System that were distributed in the United States beginning October 20, 1999. These lots contained approximately 22,000 kits with expiration dates during 2004, and included lot numbers #3990729, #3990775, #3990776, #3993006, #3003127, #3003166, and #3003355. Wyeth-Ayerst continues to conduct additional testing and analyses of the specified lots. Until this evaluation is complete, Wyeth-Ayerst is urging the following actions: - Women who began using Norplant on or after October 20, 1999 should contact their health care provider to see if their Norplant is from these affected lots. "Wyeth-Ayerst has been working with the FDA to determine the clinical significance of our original findings," says Philip de Vane, M.D., Vice President, Clinical Affairs and North American Medical Director, Wyeth-Ayerst Laboratories. "Because we do not yet have definite answers, we feel it is important to advise women using Norplant from these specified lots to use back-up, non-hormonal birth control. We expect to have additional information by the end of next month." Women who began using Norplant before October 20, 1999 are not affected and their Norplant System remains an effective, long-term contraceptive. Upon request, the Company will cover the costs of back-up birth control during the interim. Wyeth-Ayerst will also reimburse women who wish to have the affected Norplant System removed at this time. The concern about ongoing contraceptive protection in these specific lots arises from lower than expected release rates of levonorgestrel, the hormone in Norplant, found during routine laboratory testing of the shelf-life stability of the product. The effect of this lower release rate on contraceptive protection is not known at this time. The Norplant System is a five-year contraceptive implant. Norplant capsules are purchased from Leiras Oy of Finland and distributed in the Norplant System by Wyeth-Ayerst Laboratories. The most common side effects of Norplant are menstrual bleeding irregularities. These vary from woman to woman and diminish over time. Other commonly reported side effects include headache, nausea, nervousness, dizziness, and removal difficulties. Norplant System does not protect against HIV and other sexually transmitted diseases. Related Links: Norplant System (levonorgestrel implants), Wyeth-Ayerst Laboratories and American Home Products Corporation.
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