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U.S. Department of Health and Human Services

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Norplant (levonorgestrel implants) Dear Healthcare Professional Letter Jul 2002

 

This is the retyped text of a letter from Wyeth. Contact the company for a copy of any referenced enclosures.


July 26, 2002

Important NorplantĀ® System (levonorgestrel implants) Update

Back-up Contraception No Longer Required on Specified Lots

 

Dear Health Care Professional:

This letter is an update to both the August 10, 2000 and the September 13, 2000 letters from Wyeth that advised health care professionals to discontinue insertion of Norplant System kits from lots distributed beginning October 20, 1999 with expiration dates during 2004. These lots had atypically low levels of levonorgestrel release in routine shelf-life stability tests. Wyeth also advised that any patient who had received product from one of these specified lots should use back-up, nonhormonal contraception until the results of further testing could be evaluated. Women who had Norplant System insertions before October 20, 1999 were not affected.

After further evaluation, in conjunction with the Food and Drug Administration (FDA), we are very pleased to inform you that back-up contraception is no longer required in those patients who had previously been advised to use back-up, barrier, or other nonhormonal methods of contraception. Please communicate this information to women in your practice who may have been affected. A Patient Letter template is enclosed to assist you. Women who use barrier methods for other purposes, such as protection against STDs, should continue to use them.


Update

To address the problem of atypically low levels of levonorgestrel release, investigations were conducted by Wyeth in women with Norplant capsules from the specified lots. The data from these lots do not suggest less contraceptive effectiveness than that reported in clinical trials. Because of this new information, patients will no longer need to incur the inconvenience and expense of the back-up methods of contraception mentioned above. Wyeth will continue to pay for back-up, barrier, or other nonhormonal methods of contraception until December 31, 2002.


Norplant System Availability

Due to limitations in product component supplies, Wyeth does not plan to reintroduce the six-capsule NorplantĀ® System (levonorgestrel implants). Therefore, your patients will need to consider other contraceptive options as they approach the five-year expiration dates of their Norplant Systems. If your patients would prefer to have the Norplant capsules removed, Wyeth will pay for removal procedures until December 31, 2002.

We sincerely appreciate your continued understanding and cooperation in this matter and realize that it may have caused inconvenience to you and your patients. If you or your patients want further information, please call the Norplant System Information Line at
1-800-364-9809.

Wyeth is committed to being a leader in women's health care and will continue to research and develop other contraceptive options, including implants, in the future.


Side Effects of Norplant System Use

The Norplant System is a reversible 5-year contraceptive. Commonly reported side effects include menstrual-bleeding irregularities, insertion site complications, weight gain, headache, nausea, nervousness, dizziness, and removal difficulties. These vary from woman to woman. The Norplant System does not protect against HIV and other STDs.

As part of the usual spontaneous reporting program, Wyeth requests that health care professionals continue to report pregnancy and adverse events that occur during Norplant System use.

Please see accompanying Prescribing Information.


Sincerely,
Victoria Kusiak, M.D.

Enclosures

Wyeth Pharmaceuticals
PO Box 8299
Philadelphia, PA 19101-8299