Viagra, Other ED Drugs Users Report Hearing Loss

FDA Updates Product Labels

The US Food and Drug Administration announced today that users of erectile dysfunction medication are reporting sudden decreases in and/or loss of hearing. The FDA has sent alerts out to healthcare professionals, and the Administration has updated the labels and product information for Viagra, Cialis and Levitra, which are all phosphodiesterase Type 5 (PDE5) inhibitors. The same hearing loss is being linked to the drug, Revatio, which is used for pulmonary hypertension and also a PDE5 inhibitor.

Unfortunately, the follow up studies to determine the correlation between the drugs and the hearing loss are not easy and turning up little results as of today. Due to the age of many of the drugs' users, hearing loss may be hard to properly correlate with the drugs. Other conditions that the ED drug users suffer from may also be factors. The FDA however is releasing the information about the hearing loss in order to better inform health professionals and their patients as to the possible effects from use of the drugs.

The labeling has been updated under "precautions" and "adverse reactions" sections of the information in the extended label papers that come with the drugs. Tinnitus (ringing in the ear) and dizziness are also being reported in addition to the hearing problems. The information for the hypertension drug, Revatio, is currently being updated.

In an informational "question and answer" page on the FDA MedWatch website, the FDA explains that a single case of hearing loss prompted the FDA to explore other reports of hearing loss in men using the ED drugs. The FDA found that nearly 30 other cases had been noted, and that some hearing loss was reported in clinical trials of the drugs as well. The Administration does write that the effect seems to be temporary in a third of the cases reported, and there are no warning signs linked with the hearing loss. The hearing loss is also reported as one-sided.