August 24,2005

Grassley Pushes FDA to Disclose Blindness Risk of Erectile Dysfunction Drugs to Consumers

WASHINGTON – Sen. Chuck Grassley, chairman of the Committee on Finance, today continued to push the Food and Drug Administration for better disclosure to consumers of the blindness risk with erectile dysfunction prescription drugs. Grassley today sent his second strongly worded letter on the issue to FDA Commissioner Lester Crawford.

The text of his letter follows.

August 24, 2005

The Honorable Lester M. Crawford, D.V.M., Ph.D.
U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

Dear Commissioner Crawford:

Thank you for the Food and Drug Administration’s (FDA) timely response to my letter dated June 24, 2005. I requested that the FDA address questions and provide documents related to non-arteritic anterior ischemic optic neuropathy (NAION) and the use of drugs prescribed by physicians to treat erectile dysfunction (ED), including Viagra, Cialis and Levitra,.

In particular, I asked the FDA to describe, in detail, any actions that will be taken to ensure that patients are informed of NAION and its association with ED drugs. The FDA stated in a letter dated July 20, 2005, that Patient Information Sheets for each ED drug have been posted on the FDA’s website that include information about possible vision loss and patients who may be at risk for NAION. That letter also stated that information was provided to over 50,000 individualsubscribers by e-mail through MedWatch, the FDA’s safety information and adverse event reportingprogram.

According to IMS Health, a company that monitors prescription drug sales across the nation,prescriptions for ED drugs in 2004 totaled more than 18 million, including 13.9 million prescriptionsfor Viagra, 2.6 million prescriptions for Cialis, and 2.1 million for Levitra. Although there is apossibility that the 50,000 subscribers to the MedWatch e-mail list and individuals who haveaccessed the Patient Information Sheets may now be aware of the NAION risks associated with EDdrug use, there are millions more who remain in the dark. It seems likely that many millions of menwith ED drugs sitting in their medicine cabinets have not visited the FDA’s website and/or seen themedia reports about the risk of permanent vision loss. In addition, it is unlikely that these millionsof men have followed up with the physicians who prescribed them the medication because ED drugsare typically used on an as-needed basis. Dr. Crawford, who will inform these patients andconsumers of the concerns that have come to light with regard to the use of ED drugs? Has the FDAconsidered initiating other action(s) to inform adequately these millions of patients about NAIONand its association with ED drug use? More importantly, in the future, how will the FDA attempt toinform patients who do not require regularly scheduled physician follow-up about important safetyinformation regarding their medications?

Finally, the FDA has still not addressed two issues that concern me. Why did it take so longfor the FDA to negotiate the label changes for ED drugs and to notify the public of the NAION risk associated with ED drugs? The FDA has a duty to notify the public promptly about a serious risk associated with a drug and identified in the post-market. Permanent blindness surely is such a serious risk.

In closing, I look forward to hearing from you regarding this important matter by no later than September 14, 2005.


Charles E. Grassley