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Update on Advisory for Norplant Contraceptive Kits

Wyeth Pharmaceuticals of Madison, NJ, is announcing that patients who have received the Norplant System and who were using backup contraception may safely stop using backup methods for contraception. Previously, patients had been advised to use backup contraception due to concerns about lower than expected release of the hormone levonorgestrel from several specific lots. Wyeth also announced that it does not plan to resume distribution or marketing of the six-capsule Norplant System (levonorgestrel implants), which provides contraception for five years. The following may be used to respond to inquiries.

Wyeth issued letters (on July 26) to health care professionals and patients, advising patients who have Norplant System capsules from specified lots that backup contraception may safely be discontinued. The company also notified health care professionals that testing of the specified lots has not shown the effectiveness of the Norplant implants to be different from that seen in the clinical trials and product labeling. This information follows two alerts issued by Wyeth in September and October 2000 that advised doctors to discontinue insertion of Norplant system from lots distributed beginning in October 1999 due to concerns about lower than expected release of the hormone levonorgestrel from the implants.

In its letters, Wyeth said that after further evaluation, FDA and Wyeth have determined that patients do not need to use any backup, non-hormonal method of birth control. However, women who are using condoms for protection against sexually transmitted diseases should continue to use them.

Wyeth also said that, due to limitations in component supplies, the company would no longer distribute the six-implant system. Patients are also being advised that after the five-year expiration date of their Norplant system, those who want to continue using contraceptives will need to consider other contraceptive options. FDA advises patients to contact their doctors about their options. Wyeth also advises patients who would prefer to have the Norplant capsules removed that the company will pay for removal until December 31, 2002. Patients with further questions can contact the Norplant System Information Line at 1-800-364-9809.

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Wyeth Pharmaceuticals Letter to Health Care Professionals (July 26, 2002)

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