Washington (H24N). A month after sending a letter to doctors recalling about 22,000 kits of the contraceptive Norplant, Wyeth-Ayerst is warning women who possess the affected kits to use other methods of protection against pregnancy.

The drug company’s original warning advised only women who would be considered at a high risk if they became pregnant to use back-up contraception. In a statement released yesterday, however, Wyeth-Ayerst cautions all women who received Norplant on or after Oct. 20, 1999, to consider back-up methods.

After testing Norplant lot numbers 3990729, 3990775, 3990776, 3993006, 3003127, 3003166 and 3003355, the pharmaceutical company found that they didn’t contain enough of the hormone levonorgestrel to be effective as a contraceptive. The company then sent a letter to doctors asking them to discontinue using the affected Norplant lots with expiration dates in 2004.

Wyeth-Ayerst, a division of American Home Products, is still testing those lots with the help of the Food and Drug Administration (FDA) to understand how the kits were compromised.

"Wyeth-Ayerst has been working with the FDA to determine the clinical significance of our original findings," said Philip de Vane, MD, Wyeth-Ayerst’s vice president of clinical affairs. "Because we do not yet have definite answers, we feel it is important to advise women using Norplant from these specified lots to use back-up, nonhormonal birth control. We expect to have additional information by the end of next month."

Norplant is a five-year contraceptive implant. About the size of a matchstick, it is surgically inserted in a woman’s arm, where it gradually releases hormones that prevent pregnancy. Common side effects reported from Norplant use include nausea, headache, irregular menstrual bleeding, dizziness and difficulties removing the implants.

Wyeth-Ayerst said it is willing to cover the costs of back-up birth control and the cost of removing implants from women who want to have their Norplant System removed. The company will not be distributing any additional Norplant kits while testing continues.

Norplant users and their doctors who have any questions may call the Norplant System Information Line at 800-346-9809.

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