FDA approves new label for impotence drugs

ABU DHABI — The US Food and Drug Administration (FDA) on Thursday approved a new label for impotence cure drugs, which are marketed here, to more prominently display potential risk of sudden hearing loss. The labelling change applies to Viagra, Cialis and Levitra — registered, and consumed in the UAE for treating erectile dysfunction (ED).

By Nada S. Mussallam

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Published: Mon 22 Oct 2007, 8:37 AM

Last updated: Sun 5 Apr 2015, 4:51 AM

The three drugs fall into a category of drugs known as “PDE5 inhibitors”.

According to the FDA, the manufacturing companies had all agreed to the labelling change, which was prompted after the FDA reviewed 29 reports of sudden hearing loss.

The agency said the search of its adverse-events database was prompted by a case report in medical literature of a patient with sudden hearing loss who was taking Viagra.

It said the hearing loss was also reported in a few patients in clinical trials of these drugs. The FDA said that in most cases, sudden hearing loss occurred in one ear and in about one-third of the cases, the hearing loss was temporary.

“Though no causal relationship has been demonstrated, FDA believed that the strong temporal relationship between the use of PDE5 inhibitors and sudden hearing loss in these cases warranted revisions to the product labelling for the drug class,” the FDA said in a statement posted on its web site.

Speaking to Khaleej Times yesterday, a senior official of the Central Drug Control Department (DCD) at the Ministry of Health advised patients to halt using the drugs once they experienced sudden hearing loss. “In line with the FDA instructions, patients should immediately stop using Cialis, Levitra or Viagra if they had abrupt hearing loss and seek prompt medical attention,” urged the official.

Meanwhile, it has been reported that impotency has become one of the most common diseases in the region, with social stigma inhibiting men from seeking help for the disorder, that can, in most cases be cured by proper medical treatment.

ED is mainly attributed to diseases such as diabetes, hypertension and cardiovascular diseases (CVDs). Experts have also cited anxiety, stress, tiredness, illness, psychological factors and heightened alcohol consumption as common causes for ED.

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