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U.S. Department of Health and Human Services

Safety

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Norplant (levonorgestrel implants) Dear Healthcare Professional Letter Aug 2000

FDA posts safety alerts, public health advisories, press releases and other notices from companies as a service to health professionals, consumers and other interested parties. Although FDA approves medical products, FDA does not endorse either the product or the company.


This is the retyped text of a letter from Wyeth-Ayerst Pharmaceuticals, Division of American Home Products Corporation. Contact the company for a copy of any referenced enclosures.


August 10, 2000

Dear Norplant Provider:

We are writing to advise you to discontinue insertion of Norplant® System (levonorgestrel implants) from kits with a package expiration date that includes the year 2004 (lot numbers #3990729, #3990775, #3990776, #3993006, #3003127, #3003166, #3003544 and #3003355). These lots were distributed beginning October 7, 1999. We have enclosed a diagram of the Norplant System package to illustrate the location of the expiration date and lot number.

During regular quality assurance monitoring, representative samples of the above product lots tested within product specifications, but at the lower end of the release rate specification for shelf life stability. While the test in question is designed to evaluate only shelf life stability, Wyeth-Ayerst is asking you to retain packages of the Norplant System with the 2004 expiration date but not to insert the implant into patients during this period of additional testing. We recommend taking this precaution while we further evaluate the shelf life stability of these lots of Norplant and any potential clinical relevance of these findings.

Product shipped before October 7, 1999 has an expiration date of 2002 and has consistently tested within specifications. Therefore, there is no reason for concern about kits shipped before October 7, 1999. This notification refers only to product from the lots referenced above.

The product label describes a five-year cumulative pregnancy rate of 3.9 percent. While, at this time, we do not believe that there is an incremental risk of pregnancy with these lots, during this period of additional testing, for patients in whom the avoidance of pregnancy is of great importance, use of a concurrent nonhormonal (barrier) method can be considered. If the lot number used in a specific patient is not known, patients who had their Norplant System inserted after October 7, 1999 may need to be advised regarding this issue.

The additional testing and analysis should be completed in approximately one to two months and we should be able to provide additional information at that time. Wyeth-Ayerst is working with the U.S. Food and Drug Administration, physicians and scientists to review available data.

In the meantime, all shipments of the Norplant System have been suspended.

Because Wyeth-Ayerst is committed to providing safe and effective products, the company is undertaking a complete evaluation of this situation. If you have further questions, contact Wyeth-Ayerst Global Product Information at 1-800-934-5556.

Sincerely,

Philip J. deVane, M.D.
Vice President Clinical Affairs, and
North American Medical Director

Enclosure:

Wyeth-Ayerst Pharmaceuticals
Division of American Home Products Corporation
P.O. Box 8299
Philadelphia, PA 19101-8299