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Wyeth-Ayerst urges Norplant users to use back-up contraception
MADISON, New Jersey (CNN) -- Wyeth-Ayerst Laboratories, maker of the Norplant contraceptive, is advising all women who have received the contraceptive from lots distributed on or after October 20, 1999 to use a back-up contraceptive.
Laboratory testing showed the product from specific lots may not release enough hormone to deliver effective, ongoing protection against pregnancy.
Last month Wyeth-Ayerst alerted physicians to the problem and asked them to discontinue using Norplant with expiration dates in 2004. At that time, the pharmaceutical company recommended back-up contraception only for women who would be considered at high risk if they became pregnant.
Wyeth-Ayerst continues to work with the U.S. Food and Drug Administration to determine the clinical significance of the laboratory findings.
"There is no cause for panic," said Dr. Philip de Vane, vice president of clinical affairs and North American medical director for Wyeth-Ayerst Laboratories. "But since our evaluation is taking longer than expected and we can't be assured of what the results will mean, we think precautionary steps are needed."
The affected lots contain approximately 22,000 Norplant kits. According to Wyeth-Ayerst, the majority have been implanted. There are approximately 106,000 Norplant users in the United States, who account for 1 percent of all contraceptive users in the country.
The drug maker said it is willing to cover the costs of back-up birth control at this time and will also reimburse women who wish to have the affected Norplant removed.
Doctors are urged to review their patient files and contact women who've received a kit from the specified lots.
"However, we are not recommending removal at this time," said Dr. de Vane "although we would understand it if a woman felt more comfortable having it removed. We have no evidence of any women becoming pregnant with the effected contraceptives."
The company said it will not distribute any additional Norplant kits while its investigation continues. A limited number of kits are available in the community from other lot numbers, but availability will vary by region.
Norplant is a 5-year contraceptive implant that consists of matchstick size sticks that are surgically implanted in the underside of a woman's upper arm. The capsules continuously release hormones over the five years to prevent pregnancy. The most common side effect is irregular menstrual bleeding. Other reported side effects include headache, nausea, nervousness, dizziness and removal difficulties.
Wyeth-Ayerst warns doctors of possible problems with Norplant implants
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