Shelf-life stability in question.
Norplant users affected by a recently reported problem with some of the devices should consider using a barrier method of contraception pending further investigation, according to the company that manufactures the contraceptive implant.
On August 10, the manufacturer, Wyeth-Ayerst Pharmaceuticals, issued a letter to Norplant providers advising them to stop inserting implants from kits with package expiration dates in the year 2004. During regular quality assurance monitoring, representative samples of these product lots "tested within product specifications, but at the lower end of the release rate specification for shelf-life stability," according to the letter.
Wyeth-Ayerst is currently conducting additional tests; until more information is available, the kits should be retained, the letter advised. The additional testing should be completed by October 10. In the meantime, the company has suspended all shipments of Norplant kits.
The letter advised that while additional testing is underway, the use of a concurrent barrier method of contraception should be considered for those patients "in whom the avoidance of pregnancy is of great importance." However, citing the 5-year cumulative pregnancy rate of Norplant as 3.9%, the company said that "at this time, we do not believe that there is an incremental risk of pregnancy with these lots."
Providers and patients should understand that this is "a very precautionary measure on the part of Wyeth and that they should remain calm" during the 2-month period the company is investigating the problem, Dr. Kate Thomsen, medical director of the Planned Parenthood Federation of America, said in an interview.
Planned Parenthood affiliates have advised patients affected by the advisory to use a barrier method of contraception during the investigation. Removal of the implants is not recommended, she added.
The affected kits were distributed beginning Oct. 7, 1999. Their lot numbers are: 3990729, 3990775, 3990776, 3993006, 3003127, 3003166, 3003544, and 3003355.
This warning does not apply to products shipped before October 7, 1999. These have an expiration date of 2002 and have consistently tested within specifications.
More information on this alert can be obtained by calling Wyeth-Ayerst at 1-800-934-5556. A copy of the Wyeth-Ayerst letter can be found at: wwwfda.gov/ medwatch/safety/2000/norpla.htm.
COPYRIGHT 2000 International Medical News Group
COPYRIGHT 2001 Gale Group