An observational study published this week in the Archives of Otolaryngology–Head and Neck Surgery confirmed that Viagra and similar medications, known as phosphodiesterase type 5 inhibitors (PDE-5i), are associated with hearing loss. After initial reports, the Food and Drug Administration (FDA), asked manufacturers to increase the prominence of hearing loss as a potential side effect of using PDE-5i drugs, which also include Cialis and Levitra.

The study looked at data from 11,525 men over 40 years of age, and found that men who used PDE-5i drugs were twice as likely to report hearing loss as men who had not used these drugs. The effect seems to be present in all three major drugs of the class, although only Viagra had a large enough sample size to give results that seem conclusive of a real association. Said the author of the study, “It’s very difficult in observational studies to establish a cause-and-effect relationship,” but noted that the findings suggested that future study was warranted.

At the time the FDA ordered the changes to the labels for these drugs, some questioned the rationale for the order, which was based on a few isolated reports of hearing loss associated with the drugs. The FDA used fairly strong language in its initial release on the request, saying, “Although no causal relationship has been demonstrated, the strong relationship between the use of these drugs and sudden hearing loss in these cases warrants revisions to the product labeling for this drug class.” Drug manufacturers wrote warnings that highlighted the uncertainty of the relationship, without acknowledging its potential seriousness. For example, Viagra’s Safety and Side Effects Information webpage says, “It is not possible to determine whether [sudden decrease or loss of hearing is] related directly to PDE5 inhibitors or to other factors.”

This type of watering-down of warnings can often lead people to believe that the risk is less serious than the science suggests. This can lead to people not fully understanding or appreciating the risks associated with the drug.

If you have been hurt by a drug whose warning label downplayed a serious risk, you may be eligible for compensation for your injury, and the pharmaceutical injury lawyers of Robert W. Kerpsack CO., LPA can help you pursue that compensation. To learn more about your legal options, please contact us today for a free case evaluation.