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U.S. Department of Health and Human Services

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Norplant (levonorgestrel implants) Dear Healthcare Professional Letter Sep 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.


September 13, 2000

Important Norplant® System (levonorgestrel implants) Update

Dear Health Care Provider:

This letter is an update to our August 10, 2000 letter that advised health care providers who had purchased Norplant® System to discontinue insertion of kits from specific lots due to low levonorgestrel release-rate testing. This letter provides an important update to you on this issue and the actions you should take to counsel your Norplant® patients.

Update and Recommendations

  • Wyeth-Ayerst continues to conduct additional testing and analyses of the lots in question and continues to share the results of these analyses with the Food and Drug Administration. Until we can come to definitive conclusions, however, the contraceptive efficacy of Norplant® Systems from these specified lots cannot be assured.
  • Therefore, any patient who has received a Norplant® System from the lots listed below should use a back-up, barrier or other nonhormonal method of contraception, such as a condom, spermicide, a diaphragm, or IUD.
  • We also continue to recommend that there should be no new insertions of Norplant® Systems from these lots.

Specified Norplant® System lot numbers and expiration dates

3990729 [Exp 01/04] 3990775 [Exp 01/04] 3990776 [Exp 01/04]

3993006 [Exp 01/04] 3003127 [Exp 01/04] 3003166 [Exp 02/04]

3003355 [Exp 01/04]

These lots were distributed beginning October 20, 1999* and have expiration dates during 2004. Women who had Norplant® System insertions before October 20, 1999 are not affected.

* The original letter gave a distribution date of October 7, 1999. Upon further investigation we have confirmed that none of the specified lots were distributed to customers prior to October 20, 1999.

It is important that you communicate to women using Norplant® System (levonorgestrel implants) from these lots that contraceptive efficacy cannot be assured. We request your continued assistance in identifying and counseling these patients and strongly urge you to take the following actions:

1. Identify Norplant® System patients

  • Please check your patient files for any records of Norplant® System insertions beginning October 20, 1999 to determine if any women in your practice received a kit from the specified lots. Enclosed is a letter template that you may wish to use to inform these patients.
  • If you do not have access to lot number information for a particular patient, assume that any insertions performed on or after October 20, 1999 are from these specified lots.
  • If you have patients who had the Norplant® System inserted by another provider, please contact the provider for the lot number and insertion date.

2. Counsel your Norplant® System patients

  • Please notify the appropriate patients that they need to use a back-up, barrier or other nonhormonal method of contraception until our ongoing investigation is complete. Women who wish to receive financial assistance for this should call the Norplant® System Information Line at 1-800-364-9809.
  • If, in the interim, patients wish to have any of these specified lots of Norplant® System removed, Wyeth-Ayerst will cover costs associated with the removal of the Norplant® System.
  • Please be aware that there are no further Norplant® System kits available for insertion while our investigation continues.

We are also enclosing a diagram of the Norplant® System package to illustrate the location of the lot number and its expiration date. If you or your patients want more information on Norplant® System, please call the Norplant® System Information Line at 1-800-364-9809. You can also call this number if you wish to return your inventory of Norplant® System kits from the specified lots.

For your background information, and as noted in our previous letter of August 10, 2000, this issue arose when routine quality assurance testing revealed atypical shelf-life stability results for the specified lots. Wyeth-Ayerst must perform additional tests in an effort to definitively determine the clinical significance of these findings.

We recognize that this ongoing situation may cause inconvenience for you and your patients. Please be assured that we are doing everything we can to resolve this situation as quickly as possible. We will update you as more information becomes available later next month. We appreciate your cooperation and assistance with this important matter. If you have any further questions, please call the Norplant® System Information Line at 1-800-364-9809.

Please see accompanying Prescribing Information.

Sincerely,

Philip J. de Vane, M.D.
Enclosures

 

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