FDA: Viagra users may suffer sudden deafness

Men taking Viagra and other impotence drugs to treat their erectile dysfunction (ED) problem are at higher risk of having sudden hearing loss, according to the Food and Drug Administration (FDA).

The three erectile dysfunction drugs, Viagra, Levitra, Cialis that fall into a category of drugs known as Phosphodiesterase Type 5 Inhibitor, or PDE5 inhibitors, and Revatio, a drug for pulmonary hypertension, which contains the same ingredient as Viagra, can cause deafness, the federal officials said.

US health watchdog’s warning about the possible risk came after the agency reviewed 29 cases in which men taking the drug suffered sudden hearing loss.

In the 29 adverse event reports that date back to 1996, users of this family of medicines reported ringing in their ears, vertigo and/or dizziness. In most cases, the deafness occurred only in one ear, while it was in a temporary form in about one third of patients.

Pfizer is the manufacturer of Viagra and Revatio and Eli Lilly manufactures Cialis. Developed by GlaxoSmithKline and Bayer HealthCare, Levitra is jointly promoted in the United States by GSK and Schering-Plough Corporation.

Although it is still ambiguous that the drugs actually trigger hearing loss, but the FDA decided Thursday the new warnings about the potential risk will be added to the labels of drugs.

"We don't know enough to say that it's ironclad caused by the drugs, but we see enough to say we can't ignore it either," said FDA ear-and-nose specialist Dr. Robert Boucher.

The three impotence drugs Viagra, Cialis and Levitra as well as the pulmonary hypertension drug Revatio will carry the new warnings.

Although, Viagra's label already mentioned hearing loss as a possibility, because a few cases were reported during initial testing of that drug, but the health agency says that labeling does not depicts the clear link between the drug and hearing loss.

The FDA is now requiring the manufacturers of the entire class of drugs to mention more prominently the potential risk of sudden hearing loss.

According to FDA’s Website, “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.”

Sudden hearing loss (SHL) or sudden deafness is hearing loss that occurs abruptly or over a period of several days. It can be commonly caused by blood flow blockage as a result of diabetes or other illness, smoking, age and antibiotics.

The National Institutes of Health estimates that approximately 4,000 new cases of sudden hearing loss occur each year in the United States.