Senator continues push for better disclosure of blindness risk with ED drugs

September 7, 2005

Sen. Chuck Grassley (R-IA) has sent a second strongly worded letter to the FDA pushing for better disclosure of the blindness risk associated with phosphodiesterase type-5 inhibitors for erectile dysfunction.

Sen. Chuck Grassley (R-IA) has sent a second strongly worded letter to the FDA pushing for better disclosure of the blindness risk associated with phosphodiesterase type-5 inhibitors for erectile dysfunction.

In response to a letter written in June requesting FDA documentation of the risk of nonarteric ischemic optic neuropathy (NAION) and the use of these drugs, the FDA indicated that information was provided about the risk on the FDA web site and was sent to more than 50,000 prescribers through the MedWatch program. Grassley's more recent letter, sent to the FDA Aug. 24, indicated that prescriptions for ED drugs topped 18 million last year, and "there are millions more who remain in the dark."

"It seems likely that many millions of men with ED drugs sitting in their medicine cabinets have not visited the FDA's web site and/or seen the media reports about the risk of permanent vision loss. In addition, it is unlikely that these millions of men have followed up with the physicians who prescribed them the medication because ED drugs are typically used on an as-needed basis," Grassley wrote.

Grassley also asked the FDA to explain why it took so long to negotiate label changes for the drugs and to notify the public about the risk of NAION, according to a statement from the Committee on Finance, which Grassley chairs.