Viagra hearing loss warning

By Carl Saiontz
Posted October 19, 2007

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The FDA announced yesterday that they are updating the warning label for Viagra and other impotence drugs to warn about a possible hearing loss side effect.  The federal regulators identified at at least 29 reports of sudden hearing loss which occurred within hours or a few days after individuals took one of the drugs.

The class of drugs which will receive the warnings are known as phosphodiesterase type 5 (PDE5) inhibitors.   They are used to treat ED, erectile dysfunction, and millions of men take the drugs each year.  The drugs that will receive the hearing loss warning are:

• Viagra (sildenafil)
• Cialis (tadalafil)
• Levitra (vardenadil)

The warning will also be applied to Revatio (sildenafil), a drug containing the same ingredients as Viagra.  Revatio is prescribed for treatment of pulmonary hypertension, a serious lung condition.

Federal regulators at the FDA began reviewing their Adverse Events Reporting System for cases of sudden hearing loss after a case report was published in the April 2007 issue of the Journal of Laryngology & Otology.  The report outlined a case of a man who experienced sudden hearing loss after taking Viagra.  This raised red flags for the FDA to investigate the potential problem further. 

The FDA statement indicates that about one third of the cases of sudden hearing loss found were temporary.  The hearing problems experienced by the other two thirds were either ongoing at the time of the statement or the outcome was unknown.

Hearing loss was mentioned on the initial label for Viagra after a few reports were made during the clinical trials before the drug was approved.  However, after reviewing reports of the sudden hearing loss received by the FDA, officials felt that further warnings were necessary to protect consumers.

According to a report by Reuters, the National Institute on Deafness and Other Communication Disorders indicates that each year about 4,000 people develop sudden hearing loss in the United States.  Symptoms usually occur in one year, and could involve ringing in the ear, vertigo and dizziness.  While the hearing loss is temporary in most cases, the institute said that about 15% of the cases get worse over time.

The FDA recommends that individuals who experience sudden hearing loss after taking Viagra, or one of the other impotence drugs, should contact their doctors immediately and stop taking the medication.  For those taking Revatio, which is used to treat a potentially life-threatening condition, the FDA indicates patients should not abruptly stop the drug without consulting with their physician first.

In 2005, the warning labels for impotence drugs were changed to note the serious risk of sudden vision loss, known as NAION, non-arteritic anterior ischemic optic neuropathy.  The lawyers at Saiontz & Kirk, P.A. have been investigating potential Viagra vision loss lawsuits for over two years. 

If you, a friend or family member have suffered permanent hearing loss after taking Viagra, Cialis or Levitra, request a free consultation.