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Viagra Associated with Sudden Hearing Loss
In October 2007, the Viagra label was modified to include warnings about sudden hearing loss associated with the drug.  The Food & Drug Administration (FDA) had requested the changes after it had received 29 reports of patients who experienced sudden hearing loss within hours to two days of taking Viagra.

Many men who take Viagra are older, and it is not unusual for this patient population to experience some hearing loss.  But that is almost always a gradual process, and sudden loss of hearing is rare.   According to the FDA, the sudden hearing loss associated with Viagra was often accompanied by tinnitus – ringing in the ears – and dizziness.   All of the reports involved the loss of hearing in one ear, and in a third of the cases the hearing loss was temporary.

During Viagra’s pre-approval testing, some cases of hearing loss were reported.  For that reason, there was a one-word mention of “deafness” as a potential side effect on the old Viagra label.  In contrast, the new warning on sudden hearing loss is included in both the “Precautions” and “Adverse Reactions” sections of the label.  In the “Precautions” area, the label now advises physicians to warn patients that sudden hearing loss is a possible side effect of Viagra.  It also says that patients should stop taking Viagra and  seek immediate medical attention if they experience a sudden loss or decrease in hearing, or dizziness.  In the “Adverse Reactions” section, the label now warns of “sudden decrease or loss of hearing”.

Viagra Vision Loss - Nonarteritic Ischemic Optic Neuropathy (NAION)
In a recent study, US researchers describe seven patients who developed nonarteritic ischemic optic neuropathy (NAION), an eye ailment that can result in permanent vision loss, after taking Viagra (Generic: Sildenafil) for erection difficulties. Combined with past reports, this study brings the total number of sildenafil-related NAION cases to 14. Viagra was approved by the FDA in 1998.

"For years, we've known that a number of men who take Viagra will experience short-term color changes in their vision and see things as green or blue," study co-author Dr. Howard D. Pomeranz, from the University of Minnesota in Minneapolis, said in a statement. With the exception of one patient whose symptoms began 24 to 36 hours after using Viagra, the patients developed symptoms within 24 hours of use.  In all patients, the initial symptoms were blurred vision and some degree of vision loss. In one patient, both eyes were affected, whereas in the remainder, just one was involved. Three patients had preexisting eye problems that may have increased their risk of NAION.

Pfizer Inc., the world's largest drugmaker, said U.S. regulators may require a label warning that the Viagra impotence drug has been linked to reports of blindness and vision loss in at least one in a million users.  The FDA has 38 reports of the blindness among users of Viagra. Pfizer has been in discussions with the FDA about adding a disclosure to Viagra's label to say that in rare cases, men taking Viagra had developed blindness.

If you or a loved one took Viagra and suffered NAION or other side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.