On MAY 27th, 2005 the FDA Reported that the worlds most popular Erectile Dysfunction (ED) drug (Viagra, manufactured by Pfizer) may cause temporary or permanent vision loss. It was also reported that 50 cases of "Viagra blindness" as a result of Viagra side effects had been observed to date.

Viagra side effects may include visual effects from loss of a portion of the visual field to total blindness. The condition is called Non-Arteritic Ischemic Optic Neuropathy (NAION), which affects 1 to 10 out of 100,000 people. Those considered to be at risk are patients with existing blood vessel problems, like diabetes or hypertension. It usually occurs during the night when blood pressure is naturally lower.

NAION (a stroke of the eye) occurs when small arteries in the eye do not get enough blood, causing a spontaneous stroke in the optic nerve. NAION stands for Non-arteritic Anterior Ischemic Optic Neuropathy, which means optic nerve death caused by a stroke.

It is estimated that about 10 to 20 percent of people who get NAION in one eye will later get it in the other eye. Vision may spontaneously improve in about 40 percent of cases, but virtually never returns to normal. There is to date no treatment for NAION. People with abnormally sized optic nerve portions, may be predisposed to the NAION and should consult thier physician before using an Erectile Dysfunction drug such as Viagra, Levitra, or Cialis. Viagra users with diabetes may also be at higher risk of serious Viagra vision related side effects.

Although it has not been confirmed it is believed that other Erectile Dysfunction (ED) drugs such as Levitra and Cialis may also put users at risk of acute visual impairments or perhaps even permanent blindness.

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On October 18th, 2007 the U.S. Food and Drug Administration approved labeling changes for erectile dysfunction (ED) drugs in the class that includes Cialis, Levitra, and Viagra, to display more prominently the potential risk of sudden hearing loss, and to guide consumers on what to do if they experience sudden problems with their hearing.

In addition, the FDA plans to require the same changes in labeling for the drug Revatio, also a member of this drug class known as phosphodiesterase type 5 (PDE5) inhibitors. Revatio is used to treat pulmonary arterial hypertension (PAH). PAH is a serious medical condition in which continuous high blood pressure in arteries of the lungs weakens the heart muscle and often leads to right heart failure and death.

The FDA asked manufacturers of these drugs to revise product labeling after a very small number of patients taking the PDE5 inhibitors reported sudden hearing loss, sometimes accompanied by ringing in the ears and dizziness.

“Because some level of hearing loss is usually associated with the aging process, patients on these drugs may not think to talk to their doctor about it,” said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer, and acting director of its Center for Drug Evaluation and Research.

Patients taking Cialis, Levitra, or Viagra who experience sudden hearing loss should immediately stop taking the drug and seek prompt medical attention. Those using Revatio should continue taking their medication but should contact their health care provider for further evaluation. Because Revatio is used to treat a potentially life-threatening condition, the FDA does not recommend patients abruptly stop taking this medication but should consult their physician if they experience sudden problems with their hearing.

A case report in the April 2007 issue of the Journal of Laryngology & Otology involving sudden hearing loss in a man taking Viagra prompted the FDA to search the FDA’s Adverse Events Reporting System for instances of hearing loss and PDE5 inhibitors. The FDA found a total of 29 postmarketing reports of sudden hearing loss, both with and without accompanying ringing in the ears, vertigo, or dizziness. In most of the cases, the hearing loss involved one ear. The hearing loss was either a partial or complete loss of usual hearing. In approximately one third of cases, the event was temporary. In the remainder, the hearing loss was ongoing at the time of the report or the final outcome was not described.

Although no causal relationship has been demonstrated, the strong relationship between the use of these drugs and sudden hearing loss in these cases warrants revisions to the product labeling for this drug class.

Ennis & Ennis, P.A. is representing individuals that have been harmed as a result of Viagra side effects. If you or a loved one have suffered as a result of Viagra side effects you may be entitled to compensation. Click here for a free, confidential Viagra case evaluation.