ED drugs may cause sudden deafness, warns FDA

1 November, 2007

Drugs like Viagra, which successfully treat erectile dysfunction (ED) in men, may have an undesirable side effect – sudden hearing loss – the United States Food and Drug Administration (FDA) has warned.

Other erectile dysfunction drugs, implicated in an advisory released by the FDA, that have the adverse effect of sudden hearing loss are Cialis and Levitra.

The erectile dysfunction drugs, including Viagra, belong to a family of drugs called phosphodiesterase type 5 (PDE5) inhibitors.

Another drug of the same class, but used to treat pulmonary arterial hypertension (PAH) is Revatio. The FDA said Revatio would also carry warnings about possible deafness.

Pulmonary hypertension is a condition where persistent high blood pressure in the arteries of the lungs leads to right heart failure and eventually death.

The FDA approved changes in the labels of the above four drugs – Viagra, Cialis, Levitra, and Revatio – after a case report in the April 2007 issue of the Journal of Laryngology & Otology detailed sudden hearing loss in a man taking Viagra.

After examining the FDA’s Adverse Events Reporting System, the agency found 29 post-marketing reports of sudden hearing loss connected to PDE5 inhibitors.

The FDA has given the following details:

• Sudden hearing loss was also accompanied by ringing in the ears, vertigo, or dizziness.
• In most cases hearing loss was limited to one ear.
• Hearing loss was partial or complete.
• In one-third of the cases, hearing loss was temporary.

The FDA advisory said that, “though 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.”

Viagra, manufactured by Pfizer, is chemically called sildenafil and is best known for treating erectile dysfunction. The drug was initially marketed as a drug to relieve high blood pressure and angina, but soon became well-known across the world because of its ability to treat erectile dysfunction satisfactorily.

According to the National Institutes of Health, of the United States, some side effects associated with Viagra include headache, upset stomach, diarrhea, dizziness or lightheadedness, flushing (feeling of warmth), and stuffy nose.

In severe cases, Viagra has also been known to cause sudden loss of vision.

Though the FDA had not referred to this, it did warn users of Viagra that they might experience sudden loss of their hearing capacity.