US Norplant Batches May Be Ineffectivegreenspun.com : LUSENET : Grassroots Information Coordination Center (GICC) : One Thread
Thursday, August 17, 2000
Norplant batches might be ineffective
MILWAUKEE (AP) -- The maker of Norplant birth control implants is warning doctors not to use implants shipped since last October and is urging women using them to use backup contraception methods.
Wyeth-Ayerst Pharmaceuticals mailed letters last week to 9,100 Norplant providers and wholesalers asking that packages shipped beginning Oct. 7, 1999, not be used until further testing can settle questions about the product's effectiveness, the Milwaukee Journal Sentinel reported Thursday.
"We recommend taking this precaution while we further evaluate the shelf life stability of these lots of Norplant and any potential clinical relevance of these findings," Philip J. de Vane, vice president of clinical affairs and North American medical director for Wyeth-Ayerst, said in the letter.
About 1 million American women and 5 million women worldwide have used Norplant, which consists of six capsules inserted into the arm that release a synthetic hormone into the bloodstream to prevent pregnancy. It is supposed to be effective for up to five years.
Routine testing found the implants in question were not as effective as expected, although they still met U.S. Food and Drug Administration standards.
The company is unsure why the tested implants were not as potent as expected and has advised women to use alternative methods of contraception, said Audrey Ashby, spokeswoman for the company.
"We don't want women to feel that they should worry about pregnancy," she said.
The company said it will do additional testing and analysis and should be able to provide more information in a month or two.
The Planned Parenthood Federation of American received the company's letter Wednesday.
"While we don't want to be alarmists, we do want to make sure patients have all of the information they need to make decisions which guard their health," said Bonnie McEwin, vice president of communications for Planned Parenthood Federation of America.
Women using Norplant should contact the doctor who inserted the implants to determine whether further action is necessary, said Lon Newman, president of Wisconsin Family Planning and Reproductive Health Association.
Last year, the company agreed to pay a reported $54 million to more than 36,000 women to settle claims that the implants caused headaches, irregular menstrual bleeding, nausea and depression. It said the settlement was "purely a business decision" and did not admit any wrongdoing.
-- Rachel Gibson (email@example.com), August 18, 2000