The FDA is evaluating evidence of a “serious risk” of melanoma skin cancer from the following drugs:

  • Adcirca (tadalafil)
  • Cialis (tadalafil)
  • Levitra (vardenafil)
  • Revatio (sildenafil)
  • Staxyn (vardenafil)
  • Stendra (avanafil)
  • Viagra (sildenafil)

These drugs block an enzyme called PDE5, which relaxes blood vessels and improves blood-flow to certain parts of the body. This treats erectile dysfunction and arterial hypertension.

The problem is that about 50% of melanomas also inhibit PDE5. The first studies linking PDE5-inhibition and melanoma were published in 2008. Over the next few years, studies found that PDE5-inhibition accelerated the development of melanoma and made it more invasive.

In 2014, Viagra was associated with an 84% increased risk of melanoma in a study involving 25,000 men by researchers at Harvard. The numerical risk was small — only about 9 out of 1,000 men on Viagra developed melanoma — but it made major headlines.

The result was a wave of lawsuits. Pfizer, the manufacturer of Viagra, is facing more than 80 cases in California. Dozens more lawsuits have been filed against Eli Lilly & Co., the manufacturer of Cialis.

About 76,000 Americans are diagnosed with melanoma every year — about half of them men — and Viagra has been used by millions of men. That means there could be a lot of potential lawsuits if the FDA decides the drugs need stronger warnings about melanoma.

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Posted by Daily Hornet

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