Norplant Maker: Better Use Backup

A drug company will pay for thousands of women with the birth-control implant Norplant to buy backup contraception because it cannot guarantee the effectiveness of certain Norplant batches.

In a strongly worded warning Wednesday, Wyeth-Ayerst Laboratories urged women who have received Norplant since Oct. 20 to use a non-hormone form of birth control such as condoms or a diaphragm as a backup. The company also asked doctors to check their records and notify these Norplant recipients.

Wyeth-Ayerst did not recall the questionable Norplant, stressing that tests so far have not proved that the batches contain hormone levels so low as to truly risk pregnancy. The company said it wanted to err on the side of caution.

The company said it will pay $100 toward the cost of backup birth control and offered to reimburse women $700 if they choose to have the implant removed.

"The aim here is to do the right thing for people, recognizing there are still unanswered questions but saying we don't want people to be unduly anxious and we don't want them to be out of pocket," said Dr. Philip de Vane, Wyeth-Ayerst's assistant medical director.

Laboratory testing suggests about 22,000 Norplant kits shipped to doctors on Oct. 20, with the expiration date 2004, may release less contraceptive hormone than they should. Most of those kits were implanted.

Although the hormone levels are within the Food and Drug Administration's requirements, they are on the low end and lower than any other batches of Norplant. Thus, "the contraceptive effectiveness of these specified lots cannot be assured at this time," Wyeth-Ayerst said.

Additional testing due by the end of next month may prove whether the questionable Norplant's hormone levels are too low to work properly.

The FDA said it has no reports that pregnancy rates have increased among Norplant users. The agency said the company's decision to warn women about backup birth control was appropriate.

The FDA advised women who had Norplant inserted since October 20th to call their doctors about backup birth control. Norplant recipients should not use hormonal contraceptives, such as birth control pills or injected contraceptives, but should consider condoms, spermicide, a diaphragm or an intrauterine device (IUD), the FDA said.

About 1 million American women and 5 million women worldwide have used Norplant, which consists of six hormone-filled capsules that are implanted in a woman's upper arm and slowly release enough hormone to provide contraception for five years.

Women who began using Norplant before October 20th are not affected by Wednesday's warning because those implants contain the proper hormone amount.

Women and doctors can call Wyeth-Ayerst at 1-800-364-9809 for information or financial assistance.

By Lauran Neergaard