ROCKVILLE, Md. -- An FDA advisory panel has recommended that the agency expand post-marketing surveillance of oral contraceptives and require that their manufacturers study safety and efficacy in wide-ranging populations.
ROCKVILLE, Md., Jan. 25 -- An FDA advisory panel has recommended that the agency expand post-marketing surveillance of oral contraceptives and require that their manufacturers study safety and efficacy in wide-ranging populations.
Moreover, the Reproductive Health Drugs Advisory Committee declined to endorse a single standard for contraceptives, noting that while some hormonal formulations might be less effective at preventing pregnancy, they were also less likely to increase the risk of stroke and deep vein thrombosis.
The FDA itself criticized news service reports about the meeting, claiming they "created misperceptions about the effectiveness of new hormonal contraceptives." Those news stories "inaccurately" reported that newer-generation contraceptives were significantly less effective than earlier birth control pills, the FDA asserted.
"In fact, the newer generation products are highly effective in preventing pregnancy," the FDA said.
The FDA also claimed that the meeting had not been convened to discuss the need for higher standards of efficacy for new contraceptives, but rather "to discuss clinical trial designs that reflect the diversity of users of hormonal contraceptives, expectations for efficacy and safety, and user acceptability of the newer generation products, including cycle control."
The panel did not discuss implanted or injected hormonal products or other contraceptives such as condoms.
The timing of the panel was also the subject of speculation because Wyeth has asked the FDA to approve the first birth control pill designed to completely eliminate normal menstrual bleeding through continuous dosing.
Other approved pills are used to limit bleeding to a few times a year.