FDA Wants Men on ED Drugs to Listen Up
The Food and Drug Administration has asked makers of the drugs to put a warning to that effect on product labels. The alert comes two years after the drugs were linked to rare cases of vision loss, caused by a disruption in blood supply to the optic nerve.
The latest alert was prompted by a case report in the Journal of Laryngology & Otology of sudden hearing loss in a man taking Viagra. A search of FDA records found 29 similar reports involving ED drug users and a few people who took the drugs during clinical trials.
Although hearing loss is common in men in their 50s — the age group most likely to take ED drugs — age-related loss tends to be gradual, unlike the kind tied to the warning. The FDA has also issued a hearing-loss warning on Revatio, a blood pressure drug in the same class. Revatio users who experience hearing problems should stay on the drug until they have checked with their doctor.
ED drugs, on the market for more than a decade, generally have an excellent safety record. More-common problems include flushing and muscle soreness.
– Francesca Lunzer Kritz