2005P-0423 Immediately add a black box warning regarding the risks of drug-induced blindness for the three phosphodiesterase 5 inhibitors that are prescribed for the treatment of erectile dysfuntion
FDA Comment Number : EC1
Submitter : Mr. Rev Richard Wolberg Date & Time: 10/27/2005 03:10:00
Organization : IRB
Category : Health Care Association
Issue Areas/Comments
GENERAL
GENERAL
With a risk as serious as a drug induced blindness, there should definitely be an indication of how many people have been affected and what percentage it is. If the percentage of occurences of this very serious adverse event is less than a hundreth of one percent, one might feel quite differently than if there have been more than one in ten thousand. I would think other interested parties would also want and be entitled to this information. Also, is there any attempt at finding out why there has been this drug induced blindness, and if those who get it, have a good chance for recovery?