US: urgence dune analyse pour étudier les effets secondaires de la contraception
Manufacturers should collect more data on the potential side effects of birth control pills and other hormonal contraceptives after they reach the market, a advisory panel said on Wednesday.
But panel members said drugmakers were unlikely to initiate such studies because of high costs and the potential to uncover negative effects.
The panel of gynecologists, obstetricians and others told the Food and Drug Administration that while serious side effects such as blood clots are rarely seen with contraceptives, they are tough to predict and poorly understood.
Most studies used to approve contraceptive pills, patches and other devices do not include overweight women, smokers and others, making their safety among actual users unclear, the FDA's outside advisors said during a two-day meeting.
"I can't imagine the pharmaceutical companies are going to want to pay for something that may make their companies look worse," said Dr. Julia Johnson of the
Others expressed concern that the cost of collecting comprehensive data after a product is already approved could dissuade some companies.
"These are clearly going to be expensive studies," Dr. Herbert Peterson of the
The need for more safety data is increasingly important as more innovative contraceptives are being introduced, including some that limit bleeding with more frequent doses, the panel said. While such products are not a cause for special concern, their long-term effects are still unclear, they added.
"If you're going to use a (year-round) pill, is that the same as what we use now?" questioned Dr. Maria Bustillo of the South Florida Institute for Reproductive Medicine.
Traditional pills include 21 daily medicated doses followed by seven placebo doses to allow monthly bleeding.
FDA officials called for the meeting as they reevaluate how to weigh data on most hormonal contraceptives. The panel did not discuss implanted or injected hormonal products or other contraceptives such as condoms.
The panel comes as Wyeth awaits FDA approval to sell the first birth control pill that aims to do away with a menstrual bleeding through continual dosing.
Other pills, including some made by Barr Pharmaceuticals Inc., already limit bleeding to a few times a year.
Makers of other birth control pills include Johnson & Johnson and Bayer AG. J&J also markets a contraceptive skin patch, while Akzo
Some panelists questioned whether post-approval studies would truly burden drugmakers. Some companies could benefit from the results -- marketing their product as safer than others as well as discovering other potential benefits.
Dr. Scott Monroe, acting director of FDA's division of reproductive and urological products, said while the agency's power to order such studies may be unclear, it can usually collaborate with drugmakers.
"It's a negotiation process," he said.
Panelists also told the FDA that products with a slightly higher risk of pregnancy but fewer complications are acceptable as long as patients and doctors are informed.
Several women's groups also urged flexibility when evaluating new products since they can offer variety.
Additionally, the panel urged the agency to simplify product labels while exercising caution with warnings that could scare women away from contraception altogether. 20070124 lifeissues