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Levitra to Add Amnesia to Label

Erectile Dysfunction Drug Levitra to Get Label Change Noting Rare Reports of Transient Global Amnesia
By
WebMD Health News
Reviewed by Louise Chang, MD

May 29, 2008 -- The erectile dysfunction drug Levitra is getting a label change noting rare reports of transient global amnesia in men taking the drug.

Transient global amnesia, or TGA, is a brief bout of amnesia, not lasting longer than a day, without causing other problems.

Levitra's label change isn't a warning or a precaution, and it doesn't mean that the drug causes memory problems. The reported cases of transient global amnesia in men taking Levitra may have been spurred by something else, even by sex.

"Sex can trigger TGA," says Harvard neurology professor Louis R. Caplan, MD. He likens TGA to a tape recorder that's not working.

"People otherwise can walk and talk and read and do high-level things, but they're not recording the information, as if their tape recorder is off," Caplan explains.

Transient global amnesia "scares people" but it doesn't affect function, long-term memory, or other aspects of health, Caplan says. "It isn't a reason not to take the drug."

Still, men who experience transient global amnesia should see a doctor to rule out illness or injury, says Caplan, who is also an attending physician in the Comprehensive Center for Stroke and Cerebrovascular Diseases at Beth Israel Deaconess Medical Center in Boston.

Not a "Warning" or "Precaution"

Transient global amnesia will join a list of other rare, reported adverse events -- including vision problems and sudden hearing loss, which are noted for all ED drugs -- in the "Post-Marketing" section of Levitra's label.

Levitra's label got the transient global amnesia note "because of a limited number of post-marketing reports of men who experienced TGA" around the time they took Levitra, the FDA tells WebMD in an email.

But those reports don't prove that Levitra was to blame.

Bayer Pharmaceuticals and the FDA have agreed on the wording of Levitra's label change, Bayer Pharmaceuticals spokesman Mark C. Burnett tells WebMD by email. Bayer "constantly monitors product safety reports and works closely together with worldwide regulatory authorities, including the FDA, to ensure that appropriate product information is shared with physicians and with their patients," Burnett says.

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