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I suppose the trade off might be worth it....
Posted on the ASHP website:
http://www.ashp.org/s_ashp/article_news.asp?CID=167&DID=2024&id=22621
BETHESDA, MD, 19 October 2007 FDA announced Thursday that the labeling for erectile dysfunction drugs in the class known as selective phosphodiesterase (PDE) inhibitors now "more prominently" display the potential risk of sudden hearing loss in users.
Patients, according to the newly revised labeling for Cialis, Levitra, and Viagra, who suddenly lose their hearing or have a sudden decrease in hearing while using one of those PDE inhibitors should immediately stop taking the drug and promptly seek medical attention.
FDA said it plans to have the labeling for Revatio, the sildenafil product that treats pulmonary arterial hypertension, changed to note the risk of sudden hearing loss. But users of that product who suddenly have problems with their hearing should consult their physician and not abruptly stop taking the medication.
The agency said its database of adverse-drug-reaction reports had 29 accounts of sudden hearing loss in PDE-inhibitor users who took one of the products after it had been approved for the U.S. market. In most of the patients, the hearing loss reportedly occurred in one ear only.
This search of the database, FDA said, started after publication of a case report in the April 2007 issue of the Journal of Laryngology & Otology.
According to the abstract of the case report, a 44-year-old man had "bilateral profound unremitting sensorineural hearing loss" after taking sildenafil citrate 50 mg/day for 15 days. The authors, reporting from India, claimed theirs was the first case report of sildenafil-induced sensorineural hearing loss in the world literature.
The newly revised U.S. labeling for the three erectile dysfunction drugs states that a sudden decrease or loss of hearing occurred in less than 2% of vardenafil-exposed persons during clinical development of the drug and in less than 2% of sildenafil- or tadalafil-treated patients during the controlled trials. Sildenafil's labeling had previously mentioned deafness and tinnitus as adverse events that occurred in less than 2% of drug-treated patients in the controlled trials. Vardenafil's older labeling had listed tinnitus as an adverse event that occurred in less than 2% of drug-exposed persons during the drug's clinical development.
Sildenafil is sold by Pfizer Inc. under the brand names Viagra and Revatio. Tadalafil is sold as Cialis by Eli Lilly and Company. Vardenafil is marketed under the brand name Levitra by GlaxoSmithKline and Schering Corporation.
Posted on the ASHP website:
http://www.ashp.org/s_ashp/article_news.asp?CID=167&DID=2024&id=22621
BETHESDA, MD, 19 October 2007 FDA announced Thursday that the labeling for erectile dysfunction drugs in the class known as selective phosphodiesterase (PDE) inhibitors now "more prominently" display the potential risk of sudden hearing loss in users.
Patients, according to the newly revised labeling for Cialis, Levitra, and Viagra, who suddenly lose their hearing or have a sudden decrease in hearing while using one of those PDE inhibitors should immediately stop taking the drug and promptly seek medical attention.
FDA said it plans to have the labeling for Revatio, the sildenafil product that treats pulmonary arterial hypertension, changed to note the risk of sudden hearing loss. But users of that product who suddenly have problems with their hearing should consult their physician and not abruptly stop taking the medication.
The agency said its database of adverse-drug-reaction reports had 29 accounts of sudden hearing loss in PDE-inhibitor users who took one of the products after it had been approved for the U.S. market. In most of the patients, the hearing loss reportedly occurred in one ear only.
This search of the database, FDA said, started after publication of a case report in the April 2007 issue of the Journal of Laryngology & Otology.
According to the abstract of the case report, a 44-year-old man had "bilateral profound unremitting sensorineural hearing loss" after taking sildenafil citrate 50 mg/day for 15 days. The authors, reporting from India, claimed theirs was the first case report of sildenafil-induced sensorineural hearing loss in the world literature.
The newly revised U.S. labeling for the three erectile dysfunction drugs states that a sudden decrease or loss of hearing occurred in less than 2% of vardenafil-exposed persons during clinical development of the drug and in less than 2% of sildenafil- or tadalafil-treated patients during the controlled trials. Sildenafil's labeling had previously mentioned deafness and tinnitus as adverse events that occurred in less than 2% of drug-treated patients in the controlled trials. Vardenafil's older labeling had listed tinnitus as an adverse event that occurred in less than 2% of drug-exposed persons during the drug's clinical development.
Sildenafil is sold by Pfizer Inc. under the brand names Viagra and Revatio. Tadalafil is sold as Cialis by Eli Lilly and Company. Vardenafil is marketed under the brand name Levitra by GlaxoSmithKline and Schering Corporation.
