Emergency contraceptive backed.
An FDA advisory panel unanimously agreed that the selective progesterone receptor modulator ulipristal acetate is an effective emergency contraceptive with an acceptable safety profile, when used within 5 days of unprotected intercourse or a known or suspected contraceptive failure.
The FDA's Reproductive Health Drugs Advisory Committee voted 11-0 that the manufacturer, HRA Pharma, had provided enough information to conclude that micronized ulipristal reduces the likelihood of pregnancy when taken within 120 hours after unprotected intercourse or a known or suspected contraceptive failure.
If approved by the FDA, the company plans to market it as a prescription-only product under the trade name ella. Currently, the levonorgestrel-based agent marketed as Plan B or Next Choice is the only emergency contraceptive available in the United States.
The most common side effects reported were headache, nausea, dysmenorrhea, and abdominal pain, according to the company.
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|Title Annotation:||NEWS FROM THE FDA|
|Publication:||Internal Medicine News|
|Article Type:||Brief article|
|Date:||Jul 1, 2010|
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