August 10, 2016 — The FDA is deciding whether to issue warnings about the risk of melanoma from erectile dysfunction drugs like Viagra and Cialis.
On June 30, the agency began evaluating the need for regulatory action based on new information about a serious risk of melanoma from the following medications:
- Adcirca (tadalafil)
- Cialis (tadalafil)
- Levitra (vardenafil)
- Revatio (sildenafil)
- Staxyn (vardenafil)
- Stendra (avanafil)
- Viagra (sildenafil)
All of these drugs block an enzyme called PDE5, which relaxes blood vessels and increases blood-flow to certain parts of the body. They treat erectile dysfunction and arterial high blood pressure.
In 2011, a study found that blocking PDE5 made melanoma more invasive. In 2012, another study found that blocking PDE5 exacerbated the development of melanoma.
About 50% of all melanomas have a genetic mutation that inhibits PDE5. This led researchers to question whether PDE5-inhibitors like Viagra also make melanoma more aggressive.
In 2014, Viagra was linked to an 84% increased risk of melanoma in a study published in JAMA Internal Medicine by researchers at Harvard.
Pfizer is now facing more than 80 Viagra melanoma lawsuits for allegedly failing to warn about the risk. The cases are consolidated in a federal Multi-District Litigation (MDL No. 2691) in California.
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