FDA approves hormone-releasing IUD

WASHINGTON - A contraceptive IUD that releases tiny amounts of a hormone won Food and Drug Administration approval late Wednesday.

Called Mirena, the device prevents pregnancy for five years. It has long been popular in Europe.

While the FDA called it just another option for birth control, some women's advocates call Mirena a more modern IUD that may help re-ignite Americans' interest in intrauterine devices.

IUDs sit in the uterus to block conception. Worldwide, they are the most popular birth control device. But Americans were largely scared away from IUDs by the Dalkon Shield, which was blamed for painful infections, miscarriages and some deaths before it was banned in 1975.

Americans can already buy the Paragard IUD, also known as a ''copper-T'' IUD, which provides 10 years of birth control.

Mirena works through the traditional IUD design and by releasing tiny amounts of the hormone levonorgestrel into the uterus. It's about 99 percent effective at preventing pregnancy, but the ability to become pregnant quickly returns when Mirena is removed, said manufacturer Berlex Laboratories.

The FDA cautioned that women should not use Mirena if they have a history of pelvic inflammatory disease or a previous ectopic pregnancy. Nor does Mirena prevent sexually transmitted diseases.

Berlex said other side effects include breast tenderness, nausea, headaches and mood changes, which generally disappear within four months of the IUD's insertion.

In the first few months after Mirena's insertion, women may experience bleeding between menstrual cycles - but after that, many women's periods become shorter and lighter or even disappear, something the FDA listed as a side effect but that some women may call a benefit.

Berlex said Mirena will begin selling early next year but did not disclose a price.


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