Potential Risk of Sudden Hearing Loss Prompts Label Changes for ED Drugs

The U.S. Food and Drug Administration (FDA) has approved labeling changes for erectile dysfunction (ED) drugs in the class that includes Cialis, Levitra, and Viagra, to give users a more prominent notice of the potential risk of sudden hearing loss, and to guide consumers on what to do if they experience sudden problems with their hearing.

The FDA asked manufacturers of these drugs to revise product labeling after a very small number of patients reported sudden hearing loss, sometimes accompanied by ringing in the ears and dizziness, after taking them. The FDA advised that patients taking Cialis, Levitra, or Viagra who experience sudden hearing loss should stop taking the drug and seek medical attention.

A case report in the April 2007 Journal of Laryngology & Otology of sudden hearing loss in a man taking Viagra prompted the FDA to search its Adverse Events Reporting System for other cases. It found 29 other cases of sudden hearing loss, both with and without accompanying ringing in the ears, vertigo, or dizziness, reported after the drugs had been approved and marketed.

The FDA has also indicated that Revatio, a drug used to treat pulmonary arterial hypertension, may also be associated with sudden hearing loss and will also be subject to similar labeling changes. Pulmonary arterial hypertension 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. Patients taking Revatio who experience sudden hearing loss should continue taking the medication and contact their health care provider for further evaluation.

Although it is not certain that these drugs caused sudden hearing loss, the FDA said that the strong relationship between the use of these drugs and sudden hearing loss in these cases warrants a more visible warning about the potential risk.

For more information, see the FDA’s online Questions and Answers about Viagra, Levitra, Cialis, and Revatio: Possible Sudden Hearing Loss.

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