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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

Transient Global Amnesia and ED Drugs

Caplan, a transient global amnesia expert, has seen many TGA patients, but only one man who had TGA after taking an ED drug.

The patient, a 51-year-old man with a history of hypertension and migraines, had played golf in the morning. After returning home with his girlfriend, he took Viagra.

"After 30 minutes, as he was about to engage in sexual intercourse, the patient reported that he 'felt weird'... [and] could not remember that he had played golf that morning," Caplan and colleagues wrote in Neurology's Sept. 10, 2002, issue.

The man was hospitalized for a day. His memory gradually improved during that time, though he hadn't regained his lost memories when he was discharged from the hospital.

Few other cases of transient global amnesia in men taking ED drugs have been published in medical journals. Those cases include a German man who experienced TGA after he apparently took Cialis, his doctors wrote in the International Journal of Impotence Research's July/August 2005 issue.

None of the case reports confirm that ED drugs prompted transient global amnesia.

Cialis, Viagra: No Label Changes

The three erectile dysfunction drugs -- Cialis, Levitra, and Viagra -- belong to a class of drugs called phosphodiesterase type 5 (PDE-5) inhibitors. None has been shown to cause transient global amnesia.

Only Levitra is changing its label to note reports of transient global amnesia. The FDA tells WebMD it can't comment on whether the makers of Cialis and Viagra have been asked to make similar label changes.

Pfizer makes Viagra. "We can't really speculate whether the Viagra label will be updated, but we certainly do believe that the current label accurately reflects the safety and efficacy of Viagra," Pfizer spokeswoman Jennifer Jacob tells WebMD in an email.

Eli Lilly & Co. makes Cialis. "Lilly typically doesn't discuss potential label changes or regulatory action," Stephanie Kenney-Andrzejewski, senior vice president for communications firm MS&L Global Health, tells WebMD on behalf of Lilly in an email. Kenney adds that "Cialis continues to be a generally well-tolerated and effective treatment for ED," with a safety profile backed by clinical research in more than 16,000 patients and more than 11.5 million men worldwide who have been prescribed Cialis.

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