Sudden Hearing Losses Prompt Label Change for PDE5 inhibitors. The FDA said it found 29 reports of sudden hearing loss, sometimes temporary, associated with the erectile dysfunction agents after scouring the Adverse Event Reporting System. There have also been cases of sudden hearing loss reported in patients using Revatio (sildenafil) for pulmonary arterial hypertension. Medpage Today. 10/22/07. (Also see: Ear Involvement and Raynaud's)
Viagra (sildenafil citrate) Information, FDA Warning. FDA received reports of sudden decreases or loss of hearing following the use of PDE5 inhibitors, Viagra, Levitra, Cialis for the treatment of erectile dysfunction and Revatio for the treatment of pulmonary arterial hypertension. U.S. FDA. 10/22/07. (Also see: Ear Involvement and Raynaud's)
Addition of sildenafil to bosentan monotherapy in pulmonary arterial hypertension. Addition of sildenafil after bosentan monotherapy failure improved NYHA and 6MWD in IPAH (idiopathic PAH) patients, but failed to improve either parameter in PAH-SSD (scleroderma-associated PAH) patients. Additional studies are needed to assess the tolerability and efficacy of this combination in patients with PAH-SSD. PubMed. Eur Respir J. 2006 Nov 1. (Also see: Bosentan)
Revatio Approved to Treat Rare and Incurable Disease. Pfizer Canada announced today that it has received Health Canada approval for Revatio(TM) (sildenafil citrate), an important new treatment for pulmonary arterial hypertension (PAH). Sildenafil citrate is also the active ingredient in Viagra(R). CNW Group. 08/22/06.