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Information for Healthcare Professionals FDA SUMMARY [11/2007]: FDA has received reports of cases of sudden decreases or loss of hearing following the use of PDE5 inhibitors, Viagra, Levitra, and Cialis for the treatment of erectile dysfunction and Revatio for the treatment of pulmonary arterial hypertension. In some cases, the sudden hearing loss was accompanied by tinnitus and dizziness. Medical follow-up information was often limited for the cases reported postmarketing, which makes it difficult to determine whether these reports are directly related to the use of one of these drugs, an underlying medical condition, or other risk factors for hearing loss, a combination of these factors, or other factors. Sudden hearing loss was also reported in a few patients in clinical trials of these drugs. In response to a request from FDA, the manufacturers of Viagra, Levitra and Cialis have revised the labeling for these products to address the potential risk of sudden hearing loss and to guide patients on what to do if they experience sudden problems with their hearing. FDA is currently working with the sponsor to revise the labeling for Revatio. The approved revised labeling for Viagra, Levitra and Cialis includes a new Precaution and updated Adverse Reactions sections. The revised labeling is available at Drugs@FDA. This information reflects FDA’s current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available. Report serious adverse events to FDA’s MedWatch reporting system by completing a form on line at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178) by mail using the postage-paid address form provided online (5600 Fishers Lane, Rockville, MD 20852-9787),or by telephone (1-800-FDA-1088). Background Following the publication of a report in the Journal of Laryngology and Otology (April 2007), FDA conducted a search of its adverse event reporting system for cases of hearing loss in patients taking phosphodiesterase type 5 (PDE5) inhibitors. Twenty-nine postmarketing reports of sudden hearing loss defined as new hearing loss occurring over a period of 3 days or less following the last dose, both with and without tinnitus and dizziness, were identified. Sudden hearing loss was also reported in a few patients in clinical trials of these drugs. The labeling for Viagra, Levitra and Cialis was revised to address this new safety information. Revatio is sildenafil citrate marketed for treatment of pulmonary arterial hypertension (PAH) and FDA is working with the sponsor to revise labeling for this drug. Recommendations
Information for the Patient
Data Summary FDA’s analysis included all cases of hearing loss or impairment reported in clinical trials and in the post marketing setting for each of the products Viagra (sildenafil citrate); Levitra (vardenafil HCl); Cialis (tadalafil) and Revatio. Sildenafil use by patients with pulmonary arterial hypertension is both continuous and at a higher dose than for men taking sildenafil intermittently for erectile dysfunction. From the postmarketing reports, we identified a total of 29 cases of sudden hearing loss that showed a temporal relationship to dosing with a PDE5 inhibitor. Sudden hearing loss was also reported in a few patients in clinical trials of these drugs. In many cases, medical conditions and other factors may have contributed to the adverse event. Viagra:Clinical trials: A total of 5 sildenafil treated patients, of the approximately 25,000 sildenafil-treated patients from all clinical studies combined, experienced sudden hearing loss in temporal relation to dosing. Post-marketing reports: Fifteen of the postmarketing cases of sudden hearing loss had a temporal relationship and occurred in men ranging in age from 44 to 85. In 5 of the 15 cases, sudden hearing loss occurred after the first dose. Nine of the 15 cases were unilateral, one was bilateral and 5 did not specify. Sudden hearing loss was temporary (lasting 24 hrs to 2 weeks) in 4 of the 15 cases. In 8 cases, the sudden hearing loss was ongoing, and in 3 cases it was not reported if the sudden hearing loss was temporary or ongoing. Levitra: Clinical Trials: A total of 3 of the approximately 16,000 patients treated with vardenafil in all clinical studies combined experienced sudden hearing loss in temporal relation to dosing. Post-marketing reports: Five of the postmarketing cases of sudden hearing loss had a temporal relationship and occurred in men ranging in age from 38 to 74. In 2 of the 5 cases, sudden hearing loss occurred after the first dose. Two of the 5 cases were unilateral, 1 was bilateral and 2 did not specify. In 3 of the 5 cases, the sudden hearing loss was temporary, and in 2 cases the sudden hearing loss was ongoing. Cialis: Clinical trials: A total of 4 of the approximately 18,000 patients treated with tadalafil in all clinical studies combined experienced sudden hearing loss in temporal relation to dosing. Post-marketing reports: Five of the postmarketing cases of sudden hearing loss had a temporal relationship and occurred in men ranging in age from 58 to 71. In 3 of the 5 cases, sudden hearing loss occurred after the first dose. Two of the 5 cases were unilateral, 2 were bilateral and 1 did not specify. In 2 of the 5 cases, the sudden hearing loss was temporary, in 2 cases the sudden hearing loss was ongoing, and in 1 case it was not reported whether the sudden hearing loss was temporary or ongoing. Revatio: Sildenafil use by patients with PHA is both continuous and at a higher dose than for men taking sildenafil intermittently for erectile dysfunction. Clinical Trials: A total of 5 sildenafil-treated patients among the approximately 660 patients enrolled in all clinical studies reported hearing loss/impairment, including sudden hearing loss. Four of these cases occurred in an open-label extension study. Sildenafil therapy was continued in all 5 cases. In 2 cases, the sudden hearing loss resolved (2 months in one case, 1 day in the other). In 3 cases, the hearing impairment was still present at the end of the study. Post-marketing reports: A total of 4 reports of sudden hearing loss were received and occurred in 3 women and 1 man ranging in age from 36 to 63. The time to onset of sudden hearing loss ranged from less than 3 weeks to 11 months after beginning Revatio therapy and all could be reasonably associated with the use of the drug. All 4 cases involved unilateral hearing loss and were ongoing. Revatio therapy was continued for three of the reported cases and discontinued in 1 case.
Date created: November 14, 2007 |
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