The FDA is going to study a potential link between melanoma skin cancer and erectile dysfunction (ED) drugs such as Viagra, Cialis, and Levitra, according to information set forth in this document “January – March 2016: Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS)”.

In relevant part, the document listed these drugs which have been associated with melanoma as a serious side effect.

PDE-5 inhibitors:

Adcirca (tadalafil; Eli Lilly and Company): tablets

Cialis (tadalafil; Eli Lilly and Company): tablets

Levitra (vardenafil hydrochloride; GlaxoSmithKline): orally disintegrating tablets

Revatio (sildenafil citrate; Pfizer): tablets, oral suspension, and injection

Staxyn (vardenafil hydrochloride; GlaxoSmithKline): orally disintegrating tablets

Stendra (avanafil; Vivus and Auxilium Pharmaceuticals): tablets

Viagra (sildenafil citrate; Pfizer): tablets

On the legal front, a growing number of Viagra – melanoma lawsuits have been filed against the drug company Pfizer. The federal court cases were consolidated in April 2016 before U.S. District Judge Richard Seeborg in the Northern District of California. Those Viagra cases are now part of a multidistrict litigation which often goes the short name “Viagra federal court MDL 2691”.

As regards the general nature of these Viagra – melanoma lawsuits, many of the filed Complaints include allegations along these lines:

• Pfizer knew Viagra posed a cancer risk and purposely concealed facts regarding the drug’s safety;
• Pfizer failed to sufficiently investigate the link between Viagra and an increased risk of melanoma prior to
  FDA approval; and,
• Pfizer failed to warn users about the link between Viagra and the increased risk of melanoma even after studies showed the
  association, and instead continued promotion of the product.

Here are some of our earlier articles on the Side Effects Blog about this still-emerging drug safety issue:

1. Melanoma Skin Cancer Side Effect Linked To Viagra / Cialis / Levitra
2. Viagra – Melanoma MDL Motion For Federal Court Lawsuits Against Pfizer
3. Cialis / Levitra / Viagra – Melanoma: Possible Drug Safety Issue Was Raised And Left Open In A 2011 Medical Journal Article
4. The Link Between Popular Erectile Dysfunction (ED) Drug Viagra And Melanoma Has A Potential Molecular Basis According To Medical Expert Who Reviewed Recent Study
5. Viagra May Increase Risk Of Melanoma In Men Who Have Used This ED Drug, According To An April 2014 Medical Journal Article

We will continue to monitor both the legal and medical aspects developments concerning Viagra, Cialis, Levitra, and similar drugs being linked to melanoma skin cancer.

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Viagra / Cialis / Levitra
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This March 2016 Cell Reports article, “Sildenafil Potentiates a cGMP-Dependent Pathway to Promote Melanoma Growth”, presents the latest medical research results about the link between melanoma skin cancer and Viagra (sildenafil).

One of the most significant take-away points from this new medical article about the increased risk of melanoma associated with Viagra is that this skin cancer side effect most likely applies to Cialis (tadalafil) and Levitra (vardenafil), also.

In more detail, from the Discussion section of this most recent article, we get this excerpt:

Our data together with the findings of Arozarena et al. (2011)) raise concerns that the use of sildenafil (Viagra) or other PDE5 inhibitors like vardenafil (Levitra) or tadalafil (Cialis) could promote melanoma in humans. These drugs are the first-line therapy for most men with erectile dysfunction. Indeed, a recent long-term cohort study that included 14,912 men in the United States indicated that men who used [Viagra (sildenafil)] for erectile dysfunction had a significantly elevated risk of melanoma (Li et al., 2014). The link between [Viagra (sildenafil)] and melanoma development is further supported by the finding that PDE5 inhibitors promote melanin synthesis (Zhang et al., 2012), which may exacerbate melanoma development (Noonan et al., 2012). PDE5 inhibitors are also used for the treatment of benign prostate hyperplasia and pulmonary arterial hypertension, and there is a tremendous growth of preclinical and clinical studies exploring new applications of PDE5 inhibitors, such as the management of cardiovascular diseases, diabetes, and even cancer (Das et al., 2015, Ghofrani et al., 2006, Shi et al., 2011).

Two other brand name ED drugs that are phosphodiesterase 5 (PDE5) inhibitors are Staxyn (vardenafil) and Stendra (avanafil) are probably associated with an increased risk of melanoma skin cancer, too.

To expand upon two points mentioned in the Cell Reports article excerpt above:

1. Cialis (tadalafil) is also prescribed sometimes when doctors see the signs and symptoms of benign prostatic hyperplasia (BPH).
2. Two other phosphodiesterase 5 (PDE5) inhibitors, Revatio (sildenafil) and Adcirca (tadalafil), are prescribed for the treatment of pulmonary arterial hypertension (PAH).

Returning to this most recent Viagra – melanoma medical article, here is the authors’ conclusion:

Taken together, this study has uncovered a previously unknown cGMP-cGKI signaling cascade in murine and human melanoma cells. Activation of this pathway promotes tumor cell growth in vitro and in vivo. This pathway also provides a mechanism for the reported pro-melanoma effects of [Viagra (sildenafil)] and it could be an interesting therapeutic target in melanoma.

We will continue to watch for developments concerning the apparent link between Viagra and melanoma skin cancer, which seems to be a side effect of Cialis, Levitra, Staxyn, Stendra, Revatio, and Adcirca, too.

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On December 11, 2015 a legal document captioned In re: VIAGRA® PRODUCTS LIABILITY LITIGATION, MDL No. 2691 was filed with the Judicial Panel on Multidistrict Litigation (JPMDL) seeking consolidation of all Viagra – melanoma lawsuits pending in various federal courts around the country. Soon thereafter, on December 22, the Defendant in those lawsuits, Pfizer, filed a response to the Plaintiffs’ motion to transfer, agreeing that all these Viagra drug injury lawsuits should be consolidated in an MDL which should be assigned to the Northern District of California, a specific division of the federal court system.

The next JPMDL hearing is scheduled for March 31, 2016, and we expect to have the Viagra MDL ruling issued some time in April 2016, as things stand now.

Viagra (sildenafil), the most common drug prescribed for male erectile dysfunction (ED), appears to increase the risk for invasive melanoma but not cutaneous squamous cell carcinomas nor basal cell carcinomas.

Essentially, Viagra acts by inhibiting phosphodiesterase 5 (PDE5). Experimental in vitro studies show that PDE5 inhibition augments tumor cell invasiveness, supporting this new Viagra side effect finding

There are four other ED drugs which are phosphodiesterase 5 (PDE5) inhibitors:

• Cialis (tadalafil)
• Levitra (vardenafil)
• Staxyn (vardenafil)
• Stendra (avanafil)

In addition, Cialis is prescribed sometimes when doctors see the signs and symptoms of benign prostatic hyperplasia (BPH) — as some of you may know from the Cialis TV advertisements.

Two other phosphodiesterase 5 (PDE5) inhibitors are Revatio (sildenafil) and Adcirca (tadalafil). These drugs are prescribed for the treatment of pulmonary arterial hypertension (PAH).

Medical researchers involved with this still emerging drug-safety issue seem to believe that these six other drugs (in addition to Viagra) are probably associated with an increased risk of melanoma skin cancer, too.

We are currently investigating cases of melanoma in men who used Viagra, Cialis, Levitra, Staxyn, or Stendra, as well as men and women who used Revatio or Adcirca. These cases are possible drug injury lawsuits against the responsible pharmaceutical companies, not the prescribing doctors.

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Viagra / Cialis / Levitra
Free Case Evaluation

Strictly Confidential, No Obligation.

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