FDA Approves New Labeling For Viagra, Cialis and Levitra


On July 8, 2005, The Food and Drug Administration (FDA) released the official statement concerning new labeling on drugs for treating the erectile dysfunction, marketed under the brand names: Viagra, Cialis and Levitra. All these medicines have passed the FDA approval procedure and are now available for patients with the appropriate prescription from doctors. The main reason for FDA to update the information in the Post Marketing Reports section of the labels for Viagra, Cialis and Levitra is the documented facts of sudden eyesight loss in patients, taking the said pills.

As of May 18, 2005, FDA received in total 43 reports, describing the cases of vision loss in patients taking Viagra, Cialis or Levitra. This condition is called non-arteritic anterior ischemic optic neuropathy (NAION) in medicine and is caused by blocking the blood flow to the optic nerve. It is interesting to note, that the most of NAION cases (38) were associated with Viagra, 4 cases -with Cialis and only one case with Levitra.

At the same time FDA informs that the NAION condition in all described cases cannot be directly attributed to the drugs for Erectile Dysfunction, as all of these cases were reported by patients with serious risk factors for appearing of NAION condition, like age over 50, hypertension, diabetes, smoking etc.

In spite of the rather small amount of these cases in comparison to multi-million army of Viagra and Viagra-like pills customers worldwide and absence of direct arguments on Viagra as the main reason for NAION development, Food and Drug Administration obliged the manufacturers of the said pills to update the labels and patients data sheets with the information about possible eyesight loss after taking the pills.

FDA continues to monitor possible side effects of Viagra, Cialis or Levitra treatment and meantime advises patients to stop taking these medicines immediately and contact their doctors in case of sudden vision loss in one or both eyes.

The actual labeling information on Viagra, Cialis and Levitra are available at the addresses in the Internet:

http://www.fda.gov/cder/consumerinfo/viagra/vIAGRA.htm

http://www.fda.gov/cder/drug/infopage/cialis/default.htm

http://www.fda.gov/cder/drug/infopage/vardenafil/default.htm



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