FDA approves first drug for rare erection disorder

December 6, 2013

The Food and Drug Administration has approved the first drug to treat an unusual condition that causes painful, curved erections in men.

The agency says it approved the biotech drug Xiaflex (ZEE'-a-fleks) to treat Peyronie's (PEHR'-oh-nees) disease, which causes an abnormal bend in the penis during erection. The disease is caused by and can lead to pain and other difficulties during sex.

FDA says the is the first non-surgical treatment for the disease.

Drugmaker Auxilium Pharmaceuticals estimates 5 percent of U.S. men are affected.

The FDA said it is limiting distribution of the drug to certified physicians and health care centers due to serious potential side effects, including injury of the penis. Health care professionals must enroll and complete a before prescribing the drug.

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