More Data Indicating A Strong Association Between Sildenafil Use and Development of Melanoma

New Report Finds Increased Risk of Melanoma for users of sildenafil (a.k.a Viagra, Revatio) or tadalafil (a.k.a. Cialis, Adcirca)

December 13, 2018

A recent study from the Research on Adverse Drug Events and Reports (RADAR) project finds a statistically significant increased risk of melanoma for individuals who used sildenafil (a.k.a Viagra, Revatio) or tadalafil (a.k.a. Cialis, Adcirca). The study examined individuals who used sildenafil or tadalafil daily for control of pulmonary hypertension finding them to have a 298% increased risk of melanoma compared to individuals who did not use sildenafil or tadalafil. The study was published in the September 2018 volume of the Journal of the American Academy of Dermatology as a peer reviewed poster abstract. Nardone et al., Chronic Daily Dosing of PDE5 Inhibitors (Sildenafil or Tadalafil) for Pulmonary Hypertension & Risk of Subsequent Melanoma: A Report From the Research on Adverse Drug Events & Reports (RADAR) Project, AB72 J. Am. Acad. Dermatol 6969 (Sept. 2018).

Sildenafil and tadalafil are also known as Viagra and Cialis. Viagra and Cialis are drugs commonly prescribed for treatment of erectile dysfunction (ED). The same drugs are also known as Revatio and Adcirca, prescribed for treatment of pulmonary hypertension (PH). These drugs are referred to as phosphodiesterase type 5 inhibitors (PDE5 inhibitors). 

The authors note that the reported association may be explained by the involvement of the PDE5 gene in a signaling pathway for melanoma. In 2011, a study in Cancer Cell concluded that PDE5 inhibitor drugs (sildenafil and tadalafil) “could promote melanoma metastases.” Arozarena et al., Oncogenic BRAF Induces Melanoma Cell Invasion by Downregulating the cGMP-Specific Phosphodiesterase PDE5A, 19 Cancer Cell 45, 55 (Jan. 2011). In 2014, a prospective cohort study found a statistically significant association between sildenafil use for treatment of ED and melanoma. Li et al., Sildenafil Use & Increased Risk of Incident Melanoma in US Men: A Prospective Cohort Study, JAMA Intern. Med. (Apr. 2014).

Additional studies followed, many finding increased risks of melanoma or plausible signaling pathways by which PDE5 inhibition might contribute to melanoma development. One author, Stacy Loeb, despite her studies finding an increased risk, questioned whether the association was causal. Dr. Loeb is a paid consultant for Eli Lilly—the manufacturer of Cialis and Adcirca. See Corrigendum, 109 JNCI (Aug. 2017) to Loeb et al., Meta-Analysis of the Association Between PDE5Is & Risk of Melanoma, 109 JNCI (originally published online May 19, 2017).  

The findings from the most recent RADAR study are significant. Because sildenafil and tadalafil for treatment of PH are used daily, the individuals using these drugs appear to have an even greater risk than those using the drugs as needed for treatment of ED.

Robins Kaplan represents individuals who allege melanoma injuries from use of sildenafil and/or tadalafil, whether for treatment of ED (Viagra and Cialis) or PH (Revatio and Adcirca). If you used Revatio or Adcirca for treatment of PH and were later diagnosed with melanoma, please call us today at 1.800.255.5223 for a free consultation.


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