New questions about the safety of Viagra, the first FDA-approved drug to treat erectile dysfunction, could prompt a new warning label on the drug. Pfizer, Inc., the drug's manufacturer, says government regulators are considering their alternatives in the wake of reports linking Viagra to vision problems.
Pfizer says it has received reports of 23 cases in which men taking the drug have either gone blind or lost a portion of their vision. Even though it's a small number of cases, in relation to the more than one million men who have taken the drug since its introduction in 1998, the reports are getting serious attention at the FDA. Regulators are meeting with company officials to receive an update on information Pfizer has gathered.
The FDA, meanwhile, says it has received information about 38 cases in which men taking Viagra had suffered vision impairment. The FDA says those cases were tied to reduced blood flow to the eye in patients who were also suffering from diabetes and high blood pressure.
The warning label on Viagra currently warns those taking the drug about vision related side effects. Other side effects reportedly include increased pressure around the eye and retinal vascular disease. Some analysts think, at the very least, a stronger warning on Viagra is the likely result of the current agency-company discussions. An FDA spokeswoman says people concerned about the latest developments should consult with their doctor.
From a business standpoint, it's another hammer blow to Pfizer. The company took a hit last year when problems developed with its pain relievers Celebrex and Bextra. Both were linked to increased cardiovascular risks.
