Nearly 25 years ago, Pfizer introduced a new, revolutionary drug into the market that became an instant classic: sildenafil, more popularly known as Viagra®.
Viagra® became an overnight success, enjoying massive commercial success as the pre-eminent solution for erectile dysfunction (ED). Within a few months, Viagra® became the talk of the town on every late-night TV show, street corner, and conversation among adult men.
Pfizer owned the exclusive patent to Viagra® and its active ingredient sildenafil in doses for ED until 2020, which opened the door for other pharma companies to create generic, off-brand versions of the best-selling ED drug at lower prices without sacrificing any of its effectiveness or mechanism of action.
This made unbranded Viagra® infinitely more accessible to a wider global audience, which serves as a testament to its success.
However, Viagra® and its ilk, the drugs that belong to a category of medications called PDE5 inhibitors, have generated their share of controversy, one of which is hearing loss. This class of drugs includes sildenafil (Viagra®), tadalafil (Cialis®), and vardenafil (Levitra®).
According to a news report published by the Daily Telegraph, Viagra® and other PDE5 inhibitors could make you “go deaf” based on limited research linking several hundred cases of sudden hearing loss in ED patients taking PDE5 inhibitors.
Based on the limited research surrounding hearing loss and PDE5 inhibitors, some individuals have reported hearing loss in one ear after one day of taking any of these ED drugs. In one-third of the cases, the hearing loss is temporary.
The research was focused on studying a condition known as “sudden sensorineural hearing loss” or SSHL in patients taking sildenafil and similar PDE5 inhibitors for ED. While the symptoms may be distressing, SSHL is a rather rare condition caused by damage to the inner ear’s structures, which may lead to permanent hearing loss. The research found two-thirds of hearing loss occurs within 24 hours of taking a PDE5 inhibitor.
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Is there any evidence that sildenafil (Viagra®) and other PDE5 inhibitors cause hearing loss?
In 2007, a report concerning a man who experienced sudden hearing loss in both ears after taking Viagra® was published in the Archives of Otolaryngology-Head and Neck Surgery.
The incident prompted the United States Food and Drug Administration (FDA) to keep track of similar cases in men experiencing hearing loss or tinnitus after taking PDE5 inhibitors.
A larger study found an identical link: men using PDE5 inhibitors were twice as likely to report hearing loss as men who haven’t taken ED medications.
However, the research couldn’t prove a conclusive cause-and-effect link. PDE5 inhibitors are known for producing side effects such as gastrointestinal discomfort, problems perceiving color or seeing, and headaches.
The findings persuaded the FDA to issue a new warning, leading to more information being included on ED drug labels, duly noting that a sudden decrease in or loss of hearing, sometimes with tinnitus or ringing in the ear, has rarely been reported in PDE5 inhibitors, sildenafil (Viagra®) included.
It must be noted that it’s impossible to determine if such events are directly related to taking Viagra® and other PDE5 inhibitors and their generic counterparts, to other pre-existing conditions or medicines, or a combination of several factors.
Granted, the reports of cases on SSHL associated with PDE5 inhibitor use add value in drawing attention to a potentially serious side effect. But the truth is, the studies do not conclusively tell us that PDE5 inhibitors actually cause hearing loss and how frequent such a (comparatively rare) side effect might be.
In other words, the authors of the study linking SSHL to PDE5 inhibitor use is entirely speculative and based on assumptions regarding SSHL and PDE5 inhibitor use, both of which are as of yet not very well understood and recognized.
Rather, a full, unencumbered, and systematic review of clinical trials, case reports, and observational studies is required, just as full disclosure of all possible adverse effects to determine how common or rare SSHL might be.
That said, if you experience any of the symptoms mentioned above, stop taking sildenafil (or whichever PDE5 inhibitor you are taking) and see a doctor immediately.
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What are the symptoms of sudden hearing loss?
According to the National Institute of Deafness and Other Communication Disorders, SSHL is a rapid, unexplainable loss of hearing at once or over several days.
A sudden decrease or total loss of hearing is considered an emergency requiring immediate medical attention. If you experience symptoms related to sudden hearing loss, tell your treating doctor that you took a medicine linked to SSHL.
If you have been diagnosed with ED and prescribed a PDE5 inhibitor like sildenafil (Viagra®), tadalafil (Cialis®), or avanafil (Levitra®), ask your doctor about the benefits and risks associated with their use, including hearing loss.
Conclusion
Regardless of their perceived safety and successful track record, all drugs require constant monitoring and reporting of possible side effects. The studies mentioned in this article are important in demonstrating the possible adverse effects of medicines that may not have been earlier detected in prior trials.
