FDA Looking Into Blindness-ED Drug Link

FDA Investigating Rare Reports Of Blindness Amoung Men

Using Impotence Drugs Like Viagra, Cialis, Levitra

Associated Press

WASHINGTON, DC May 27, 2005 1:00pm EDT - Federal health officials are investigating rare reports of blindness among some men using Viagra and other impotence drugs but caution that this type of vision loss also is linked to the same illnesses that lead to impotence.

The questions about the impotence drugs come at a time when federal regulators and the drug industry are facing criticism about what they do to ensure the safety of drugs already on the market.

The Food and Drug Administration has 43 reports of varying degrees of vision loss, including blindness, among users of the drugs: 38 among Viagra users, four among Cialis users and one among Levitra users, said spokeswoman Susan Cruzan.

The FDA now is in discussions with the makers of the drugs about whether the labels should contain a disclosure that in very rare cases, users had developed blindness.

"We take this seriously," Cruzan said.

The makers of Cialis, Eli Lilly & Co. and ICOS Corp., already have voluntarily added a single-line notice to that drug's label.

At issue is NAION, or non-arteritic anterior ischemic optic neuropathy, which causes sudden vision loss when blood flow to the optic nerve is blocked.

NAION is considered one of the most common causes of sudden vision loss in older Americans, and estimates suggest there are anywhere from 1,000 to 6,000 cases a year. Risk factors include diabetes and heart disease two of the leading causes of impotence.

The routine NAION cases plus overlapping risk factors means it may be impossible for FDA to tease out whether the drugs really increase risk for this eye problem.

Viagra maker Pfizer Inc. says about 23 million men worldwide have taken Viagra since its approval in 1998. There is no proof that the drug caused the blindness, stressed Pfizer spokesman Daniel Watts.

But the possibility of a link was raised publicly earlier this year, when Dr. Howard Pomeranz of the University of Minnesota reported in an opthalomology journal seven patients who reported NAION vision loss occurring within 36 hours of a Viagra dose.

So Mom was right when she said that doing it alone will cause blindness?