Company To Pay Some Norplant Users
Wednesday, September 13th 2000, 12:00 am
By: News On 6
WASHINGTON (AP) â€” The maker of Norplant said Wednesday that it cannot guarantee certain batches of the birth-control implants are effective, and announced it will reimburse women who have questionable implants for the cost of backup birth control.
Women who have received Norplant implants from batches that were shipped to doctors on or after Oct. 20 should use a nonhormone form of birth control as a backup, Wyeth-Ayerst Laboratories said.
``The contraceptive effectiveness of these specified lots cannot be assured at this time,'' the company said.
Wyeth-Ayerst first wrote doctors last month telling them to stop inserting those implants, because laboratory testing for shelf-life stability suggested some might release less contraceptive hormone than they should, raising questions about effectiveness.
In a second letter to thousands of doctors Wednesday, the company insisted additional tests still must be done to prove if those lower hormone levels really put women at risk of pregnancy â€” yet it still urged physicians to search their records and immediately notify patients who should use a backup.
The Food and Drug Administration advised women Wednesday not to wait to be notified, but to call their doctors if they had Norplant inserted since Oct. 20 and specifically ask about backup birth control.
Women who have Norplant should not use hormonal contraceptives, such as birth control pills or injected contraceptives, because Norplant itself contains the hormone levonorgestrel, the FDA said. Instead, women should consider condoms, spermicide, a diaphragm or an IUD.
Wyeth-Ayerst said it will pay up to $100 to women who request financial assistance for the backup contraception. In addition, Wyeth-Ayerst will reimburse women $700 if they wish to have the questionable Norplant removed â€” although the company is not recommending that yet, saying it has no reports of increased pregnancy rates among Norplant users.
Women and doctors may call the company at 1-800-364-9809 for information or financial assistance.
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.
Wyeth-Ayerst said it expects additional testing by the end of next month to settle questions about seven batches of Norplant shipped starting Oct. 20, 1999. Women who began using Norplant before Oct. 20 are not affected, because those implants contain the proper hormone amount.
On the Net:
Food and Drug Administration: http://www.fda.gov