FDA Investigating Erectile Dysfunction Drugs and Melanoma

August 10, 2016 — The FDA may soon issue warnings about the risk of melanoma (skin cancer) from drugs like Viagra and Cialis.

On June 30, the FDA announced that it was investigating new information about a serious risk of melanoma from the following drugs:

• Adcirca (tadalafil) tablets
• Cialis (tadalafil) tablets
• Levitra (vardenafil hydrochloride) orally-disintegrating tablets
• Revatio (sildenafil citrate) tablets, oral suspension, and injection
• Staxyn (vardenafil hydrochloride) orally-disintegrating tablets
• Stendra (avanafil) tablets
• Viagra (sildenafil citrate) tablets

These drugs work by inhibiting an enzyme called Phosphodiesterase (PDE)-5. The first correlation between PDE5 and melanoma was reported in 2008.

In 2011, researchers discovered that inhibiting PDE5 makes melanoma more invasive. Another study published in 2012 found that PDE5 inhibition could exacerbate melanoma development.

About 50% of melanomas have a mutation that inhibits PDE5, making them develop and spread more quickly.

These studies led researchers to question whether medications that inhibit PDE5 also make melanoma more aggressive. In 2014, Viagra was associated with an 84% increased risk of melanoma in a study published by JAMA Internal Medicine.

As of mid-July, Pfizer was facing 80 Viagra melanoma lawsuits. The cases are centralized in a federal Multi-District Litigation (MDL No. 2691) in the U.S. District Court for the Northern District of California.

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