Viagra®, Levitra®, or Cialis® Use Can Increase Risk of Vision Loss
FDA Warns Viagra®, Levitra®, and Cialis® Users About Eye Problems
WASHINGTON, DC — July 15, 2005 — Some users of the impotence drugs Viagra® (sildenafil), Levitra® (vardenafil), and Cialis® (tadalafil) have suffered from sudden blindness, according to the Food and Drug Administration (FDA). The agency has asked that labels for these medications include warnings about NAION (non arteritic ischemic optic neuropathy), a condition in which blood flow is blocked to the optic nerve, often resulting in permanent, severe vision loss (FDA Press Release, July 8, 2005).
So far, the FDA has reported 43 cases of NAION in those using the impotence drugs (Alert for Health Professionals, July 2005). Thirty–eight cases have been linked to Viagra®, four to Levitra® and one to Cialis®. CBS News put the number of Viagra® users with eye problems at 500, however, with about 140 reports of partial or sudden blindness (Washington Post, July 1, 2005).
The FDA backed off saying that the use of Viagra®, Cialis®, or Levitra® could cause NAION. It noted that the risk of the disease is greatest in men over the age of 50 who have heart disease, diabetes, high blood pressure, high cholesterol or a history of smoking.
The agency first publicly announced a possible link between NAION and impotence drugs in June, three months after a journal article reported that seven men had developed NAION within 36 hours of taking Viagra® (J Neuroophthalmol. 2005 Mar; 25(1): 9–13). However, in a letter to the FDA, Sen. Charles Grassley (R–IA) charged that the agency knew about the blindness risks since January 2004 (Washington Post, July 1, 2005). The letter is based on talks with an FDA safety officer, who reported her findings to other FDA staff members at that time. Grassley also questioned whether the FDA’s adverse event reporting system was adequate to detect eye problems in Viagra® users since most doctors did not know about the connection between NAION and the drug until recently.
“It shouldn’t take bad publicity to get the FDA to act on the advice of its own scientists and do everything it can to inform and protect the public,” Grassley commented about the recent label update for Viagra®. “Why did it take more than a year in this case?” (Washington Post, July 9, 2005).
The FDA now advises patients to call their doctors immediately and stop taking Viagra®, Levitra®, or Cialis® if they experience sudden vision loss or blindness in one or both eyes. Also, patients using these medicines should inform their doctors if they have ever had severe vision loss, which may be a sign of a prior episode of NAION, the agency said. Such patients are at an increased risk of developing the condition again.
Other Side Effects of Viagra®, Levitra®, and Cialis®
The FDA first approved Viagra® in March, 1998, to treat impotence or erectile dysfunction, a condition that affects millions of men in the United States. Levitra® was approved in August, 2003, and Cialis® was approved in November, 2003.
Besides eye problems, other side effects of the impotence drugs may include headache, flushing, stuffy nose, indigestion, and dizziness. None of the three drugs should be used if one takes medicines called alpha blockers, which are prescribed for high blood pressure or prostate symptoms. Patients should also not take Viagra®, Levitra®, or Cialis® if they use “nitrates,” which are often used to control chest pain, or take recreational drugs called “poppers” (amyl nitrate and butyl nitrate). Use of the impotence drugs along with nitrates or alpha blockers can cause very low blood pressure.
For further details about impotence drugs, see the FDA patient information sheets and prescribing information for Viagra®, Levitra®, and Cialis®. If you have been injured by an unsafe medicine, please feel free to contact us at Brayton Purcell to learn about your legal options. We have been successfully handling medically–related legal cases for over 20 years, and work hard on behalf of our clients.
