Wyeth Contraceptive Approved

The Food and Drug Administration has approved Wyeth's(WYE) Lybrel, the first oral contraceptive that eliminates a woman's monthly periods.

Clearance had been expected after the FDA recently said Wyeth's Puerto Rico manufacturing plant had corrected problems cited by the agency 12 months ago. Without the FDA signing off on the plant, Wyeth had been blocked from making new drugs there.

"The risks of using Lybrel are similar to the risks of other conventional oral contraceptives and include an increased risk of blood clots, heart attacks and strokes," the FDA said Tuesday afternoon.

Wyeth will conduct a post-marketing survey to determine if Lybrel causes any side effects that are different from those caused by other contraceptives, said Dr. Daniel Shames, a deputy director at the FDA's office of drug evaluation. "We don't expect any surprises," Shames told reporters during a telephone press conference.

Because Lybrel eliminates regular periods, Shames said "it may be difficult for women to recognize if they have become pregnant." He recommended that they take a pregnancy test if they believe they may be pregnant. Lybrel will be available in July. Barr Pharmaceuticals(BRL) makes two contraceptives that reduce the number of periods to four per year.

Lybrel contains levonorgestrel and ethinyl estradiol, which are active ingredients available in other approved oral contraceptives. The drug was cleared after the FDA evaluated a pair of 12-month clinical trials involving 2,400 women ages 18 to 49.

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