Labels on Viagra, Cialis and Levitra are Changed to Address Blindness Issue

On July 8, 2005 the FDA ordered warnings be put on the package insert labels of Viagra, Cialis, and Levitra to the effect that some users of these impotence drugs — or erectile dysfunction (ED) drugs — have developed NAION, a form of blindness.  At the same time, however, the FDA stated that it is impossible at present to know if NAION is a side effect of these ED drugs, or an unrelated medical condition.

NAION, or non-arteritic anterior ischemic optic neuropathy, manifests as a sudden vision loss when there is an interruption of blood flow to the optic nerve.  NAION is considered one of the most common causes of sudden vision loss in older people, with anywhere from 1,000 to 6,000 cases a year.  The difficulty for the FDA and others in ascertaining whether NAION is a side effect of these several ED drugs — namely, Viagra, Cialis, and Levitra — is that the acknowledged risk factors for developing NAION include diabetes and heart disease, which are two of the leading causes of impotence.  Moreover, other recognized risk factors include being over age 50, high blood pressure, high cholesterol, and smoking.

The changes to the ED drug labels follow 43 reports of sudden vision loss or deterioration to the FDA which had to do with men who took Viagra, Cialis, or Levitra for erectile dysfunction.  Specifically, Viagra (Pfizer Inc.) was the subject of 38 NAION cases, Cialis (Lilly ICOS) was named in four FDA reports, and Levitra (Bayer AG, Schering-Plough Corp., GlaxoSmithKline PLC) was named in one FDA report.

The FDA has advised patients to stop taking Viagra, Cialis, or Levitra — and immediately call a doctor — if they experience sudden or decreased vision loss in one or both eyes when using one of these ED drugs.  Furthermore, the FDA stressed that men should report to their doctor, now, if they had ever suffered such sudden vision loss or deterioration in the past, because patients who have had an initial incident of NAION are at an increased risk of having a subsequent incident.

For more, you can read the FDA’s July 8, 2005 statement about post-marketing reports of NAION concerning Viagra, Cialis, and Levitra, which includes a link to each of the revised warning labels.

(Posted by: Tom Lamb)