US FDA Orders Hearing Loss Warning Added to Viagra
The US Food and Drug Administration announced on the 18th October that Viagra, and other drugs within its class, will now be sold with revised labelling highlighting the possibility that it could induce rapid hearing loss in some users. Medical research has not yet conclusively proved the Viagra/hearing loss connection, but the announcement follows 29 reported instances that have occurred over the past decade.
As well as Viagra, the warning will be included on the labelling attached to Levitra, Cialis and Revatio – the latter, not a medication for erectile dysfunction, but a bloodthinner containing the same ingredients.
The labelling on Viagra already makes reference to possible hearing loss, based on a handful of incidents that took place when the drug was first trialled. However, given that loss of hearing is synonymous with advancing age, the link’s strength was unclear. That, according to the US FDA’s Dr Robert Boucher, is still the case.
However, when the 29 hearing loss reports were analysed together, a commonality emerged in that they all happened within two days of Viagra being taken. "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", asserted Dr Boucher.
The reports additionally showed the hearing loss to be confined to a single ear. In around 10 of the instances, the problem was temporary and full hearing was recovered.
The administration has stressed the need for patients taking Viagra to contact their doctors urgently if they notice any abnormalities in their hearing.
Viagra is made by Pfizer – the globally dominant pharmaceutical company. Official data shows the drug to have achieved sales of $450 million in a recent three-month period.
The National Institute on Deafness and Other Communication Disorders says that approximately 4,000 new reports of unprecedented hearing loss are made per annum in the US. It adds that around 85 per cent of these involve subsequent recovery.
Source – Pharmaceutical International’s US Correspondent
Recent related News Items:
