Viagra could double risk of hearing loss
Viagra could double risk of hearing loss | Reuters
Frederik Joelving
Wed May 19, 2010 5:20pm EDT
NEW YORK (Reuters Health) - Is an erection worth becoming hard of hearing?
A new US study suggests men who take Pfizer's Viagra (sildenafil) or similar drugs for erectile dysfunction may double their chances of hearing impairment, bolstering a Food and Drug Administration warning from 2007 about this side effect.
High doses of Viagra have been shown to damage hearing in mice, but until now only a few anecdotal cases had been described in humans.
The study, based on a national sample of American men over 40, found that slightly more than one in six of those who did not take Viagra-like drugs -- for instance, Eli Lilly's Cialis -- were deaf or hard of hearing.
Among those who took the drugs, however, almost one in three had hearing loss, Gerald McGwin, an epidemiologist at the University of Alabama at Birmingham School of Public Health, told Reuters Health.
Even after accounting for other factors linked to hearing loss, hard-of-hearing men still had twice the odds of taking Viagra, said McGwin, whose findings appear in the journal Archives of Otolaryngology--Head & Neck Surgery.
However, he said, more research is still needed to confirm the findings.
Drug makers already include a "black box" warning about potential hearing loss on these products. But the new results expand on that concern, said Dr. James E. Saunders, an ear doctor with Dartmouth Hitchcock Medical Center in Lebanon, New Hampshire.
"Before the current paper the focus has always been on sudden hearing loss," Saunders, who was not involved in the study, told Reuters Health. "This study suggests that maybe there are small incremental changes that occur over time."
While he noted that the study relied on self-reporting of hearing loss, which has been criticized as inaccurate, he said at this point he would advise patients with hearing loss not to take the drugs.
But for men with normal hearing and erectile dysfunction, comparing a potential side effect to a real problem might tip the scale, he added.
"The few times that I've had that conversation with patients it's kind of a difficult decision," he said.
Sudden Hearing Loss from Erectile Dysfunction Drugs
http://www.accessdata.fda.gov/psn/printer-full.cfm?id=95
FDA has received about 30 reports of sudden hearing loss in patients taking a class of erectile dysfunction drugs called PDE5 inhibitors. This class of drugs includes Viagra (sildenafil), Cialis (tadalafil) and Levitra (vardenafil). The problem was sometimes accompanied by tinnitus, vertigo, or dizziness. In most cases the hearing loss involved one ear, and about a third of the time it was temporary.
Medical follow-up information was often limited for the reported cases, 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.
FDA has asked the manufacturers of these erectile dysfunction drugs to display the risk of hearing loss more prominently in the labeling, and to guide patients on what to do if they experience hearing problems while they are on the drugs. The revised label will advise clinicians to let patients know that sudden hearing loss may be due to the drug, and to stop taking the drug and seek medical attention if they experience any sudden decrease or loss of hearing.
Another PDE5 inhibitor, Revatio, also contains sildenafil, the same active ingredient as in Viagra. However, Revatio is used to treat pulmonary arterial hypertension rather than erectile dysfunction. FDA is working with the manufacturer of this drug to revise its labeling, too. Because pulmonary hypertension is a life-threatening condition, patients taking Revatio should not stop taking their medication, but should be instructed to contact their physician promptly if they experience sudden hearing loss.
Additional Information: FDA MedWatch Safety Alert. Viagra (sildenafil), Cialis (tadalafil), Levitra (vardenafil), Revatio (sildenafil). October 18, 2007. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm152967.htm
McGwin G, Jr. Phosphodiesterase Type 5 Inhibitor Use and Hearing Impairment. Arch Otolaryngol Head Neck Surg;136(5):488-92.
Objective To compare use of phosphodiesterase type 5 inhibitors (PDE-5i) between participants with and without self-reported hearing impairment using logistic regression, with and without adjustment for potentially confounding sociodemographic, behavioral, and health-related characteristics.
Design Cross-sectional.
Setting United States.
Patients A population-based sample of 11 525 men 40 years or older (248 217 013 weighted men) in the United States, selected from the Medical Expenditure Panel Survey (2003-2006).
Main Outcome Measure Self-reported hearing impairment.
Results The overall prevalence of self-reported hearing impairment and PDE-5i use in each group was 17.9% and 2%, respectively. Men who reported hearing impairment were more likely to have also reported the use of any PDE-5i (odds ratio [OR], 2.23; 95% confidence interval [CI], 1.36-3.66). However, this association was limited to sildenafil (Viagra) (OR, 2.05; 95% CI, 1.23-3.43); no significant associations were observed for tadalafil (Cialis) or vardenafil (Levitra) (ORs, 1.40 [95% CI, 0.49-4.04] and 0.88 [95% CI, 0.35-2.22], respectively).
Conclusions Current warnings regarding the risk of hearing loss related to PDE-5i use seems to be justified. However, the cross-sectional nature of the current study provides only limited insight regarding this relationship, and thus additional research is warranted.
Viagra could double risk of hearing loss | Reuters
Frederik Joelving
Wed May 19, 2010 5:20pm EDT
NEW YORK (Reuters Health) - Is an erection worth becoming hard of hearing?
A new US study suggests men who take Pfizer's Viagra (sildenafil) or similar drugs for erectile dysfunction may double their chances of hearing impairment, bolstering a Food and Drug Administration warning from 2007 about this side effect.
High doses of Viagra have been shown to damage hearing in mice, but until now only a few anecdotal cases had been described in humans.
The study, based on a national sample of American men over 40, found that slightly more than one in six of those who did not take Viagra-like drugs -- for instance, Eli Lilly's Cialis -- were deaf or hard of hearing.
Among those who took the drugs, however, almost one in three had hearing loss, Gerald McGwin, an epidemiologist at the University of Alabama at Birmingham School of Public Health, told Reuters Health.
Even after accounting for other factors linked to hearing loss, hard-of-hearing men still had twice the odds of taking Viagra, said McGwin, whose findings appear in the journal Archives of Otolaryngology--Head & Neck Surgery.
However, he said, more research is still needed to confirm the findings.
Drug makers already include a "black box" warning about potential hearing loss on these products. But the new results expand on that concern, said Dr. James E. Saunders, an ear doctor with Dartmouth Hitchcock Medical Center in Lebanon, New Hampshire.
"Before the current paper the focus has always been on sudden hearing loss," Saunders, who was not involved in the study, told Reuters Health. "This study suggests that maybe there are small incremental changes that occur over time."
While he noted that the study relied on self-reporting of hearing loss, which has been criticized as inaccurate, he said at this point he would advise patients with hearing loss not to take the drugs.
But for men with normal hearing and erectile dysfunction, comparing a potential side effect to a real problem might tip the scale, he added.
"The few times that I've had that conversation with patients it's kind of a difficult decision," he said.
Sudden Hearing Loss from Erectile Dysfunction Drugs
http://www.accessdata.fda.gov/psn/printer-full.cfm?id=95
FDA has received about 30 reports of sudden hearing loss in patients taking a class of erectile dysfunction drugs called PDE5 inhibitors. This class of drugs includes Viagra (sildenafil), Cialis (tadalafil) and Levitra (vardenafil). The problem was sometimes accompanied by tinnitus, vertigo, or dizziness. In most cases the hearing loss involved one ear, and about a third of the time it was temporary.
Medical follow-up information was often limited for the reported cases, 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.
FDA has asked the manufacturers of these erectile dysfunction drugs to display the risk of hearing loss more prominently in the labeling, and to guide patients on what to do if they experience hearing problems while they are on the drugs. The revised label will advise clinicians to let patients know that sudden hearing loss may be due to the drug, and to stop taking the drug and seek medical attention if they experience any sudden decrease or loss of hearing.
Another PDE5 inhibitor, Revatio, also contains sildenafil, the same active ingredient as in Viagra. However, Revatio is used to treat pulmonary arterial hypertension rather than erectile dysfunction. FDA is working with the manufacturer of this drug to revise its labeling, too. Because pulmonary hypertension is a life-threatening condition, patients taking Revatio should not stop taking their medication, but should be instructed to contact their physician promptly if they experience sudden hearing loss.
Additional Information: FDA MedWatch Safety Alert. Viagra (sildenafil), Cialis (tadalafil), Levitra (vardenafil), Revatio (sildenafil). October 18, 2007. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm152967.htm
McGwin G, Jr. Phosphodiesterase Type 5 Inhibitor Use and Hearing Impairment. Arch Otolaryngol Head Neck Surg;136(5):488-92.
Objective To compare use of phosphodiesterase type 5 inhibitors (PDE-5i) between participants with and without self-reported hearing impairment using logistic regression, with and without adjustment for potentially confounding sociodemographic, behavioral, and health-related characteristics.
Design Cross-sectional.
Setting United States.
Patients A population-based sample of 11 525 men 40 years or older (248 217 013 weighted men) in the United States, selected from the Medical Expenditure Panel Survey (2003-2006).
Main Outcome Measure Self-reported hearing impairment.
Results The overall prevalence of self-reported hearing impairment and PDE-5i use in each group was 17.9% and 2%, respectively. Men who reported hearing impairment were more likely to have also reported the use of any PDE-5i (odds ratio [OR], 2.23; 95% confidence interval [CI], 1.36-3.66). However, this association was limited to sildenafil (Viagra) (OR, 2.05; 95% CI, 1.23-3.43); no significant associations were observed for tadalafil (Cialis) or vardenafil (Levitra) (ORs, 1.40 [95% CI, 0.49-4.04] and 0.88 [95% CI, 0.35-2.22], respectively).
Conclusions Current warnings regarding the risk of hearing loss related to PDE-5i use seems to be justified. However, the cross-sectional nature of the current study provides only limited insight regarding this relationship, and thus additional research is warranted.
