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
"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
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