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Norplant effective but won't be back on market: Users can stop backup contraception. (Called 'a Real Loss' for Women).

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| September 01, 2002 | MacReady, Norra | COPYRIGHT 2002 International Medical News Group. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan.  All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)Copyright

Norplant has gotten a reprieve--and an execution.

In a recent letter to health care professionals, Wyeth Pharmaceuticals announced that women using Norplant from batches distributed on or after October 20, 1999, can discontinue their backup methods of contraception, thanks to evidence indicating no loss of contraceptive effectiveness in those lots.

Wyeth suspended shipment of Norplant kits in August of 2000, when questions about their efficacy were first raised. But despite the findings that efficacy was unimpaired, the company also said that it will not reintroduce the Norplant system, which contains six implantable capsules, because of "limitations in product component supplies." Repeated calls to Wyeth seeking comment on the action were not returned by press time.

The latest Norplant kits still in use were made in 1999. Since they expire within 5 years, users will have to consider other methods of contraception by 2004. Wyeth will continue to pay for implant removal or for backup, barrier, or other nonhormonal methods of contraception until December 31, 2002.

Wyeth had sent letters to doctors in August and September 2000, warning that the batches had atypically low levels of levonorgestrel release on routine shelf-life stability tests. The letters advised doctors to stop inserting new implants and to have current Norplant users employ backup contraception. An investigation has revealed that those implants are as effective as the ones distributed earlier.

Clinicians were disappointed to hear that Norplant will not be reintroduced.

"I think it would be worthwhile to have an implantable ...

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