Viagra Melanoma Risks Not Disclosed, says Lawsuit

Viagra melanomaviagra2 risks were not disclosed by Pfizer, says a lawsuit brought in California. The Big Pharma giant failed to warn men that using the erection enhancement drug could substantially raise their risk of developing the potentially deadly cancer.

The lawsuit filed September 9, 2016 charges that Pfizer knew of the melanoma risks of Viagra, yet failed to disclose them. The company’s motivation, says the petition, was to increase profits, despite the dangers to men’s health. The lawsuit charges Pfizer with aggressively promoting Viagra without admitting that the company’s own research had linked it to an increased risk of developing melanoma.

The consumers’ complaint alleges Pfizer knew or should have known about health risks associated with Viagra and Revatio. The latter is the same substance as Viagra, though Revatio, used for treating a lung condition, is sold under a different name. Pfizer failed to disclose this information on its labels or in its advertisements, says the petition.

Melanoma can be deadly
Melanoma – the most dangerous lethal form of skin cancer, according to skincancer.org – kills an estimated 10,130 people in the US yearly. It is a tumor of melanin-forming cells, typically a malignant tumor associated with skin cancer. Melanoma(s) can appear anywhere on the body.

Melanomas are cancerous growths that can develop when unrepaired DNA damage to skin cells (usually caused by ultraviolet radiation from the sun or tanning beds) triggers mutations. These mutations are genetic defects that can lead the skin cells to rapidly multiply and form malignant tumors, which originate in the pigment-producing melanocytes in the basal layer of the skin (epidermis).

Melanomas can resemble moles, and some moles develop into melanomas. While most melanomas are black or brown, they can also appear skin-colored, pink, red, purple, blue, or white.

Melanoma is caused mainly by intense, occasional UV exposure (frequently leading to sunburn), especially in people genetically predisposed.

Melanoma is nearly always curable when it is recognized and treated early. If undetected, the cancer can mutate and spread to other parts of the body, where it becomes harder to treat. Left untreated, it can be fatal. In 2016, an estimated 76,380 of diagnosed melanomas will be invasive, affecting some 46,870 men and 29,510 women.

Viagra Marketing Deceptive

Viagra marketing was deceptive, says the lawsuit. The master complaint reads, in part:
“Pfizer purposefully downplayed, understated and outright ignored the melanoma-related health hazards and risks associated with using Viagra. Pfizer also deceived potential Viagra users by relaying positive information through the press, including testimonials from retired, popular United States politicians, while downplaying known adverse and serious health effects.”

Melanoma victims dropped from studies

The master complaint charge that Pfizer should have known by the late 1990s of the connection between Viagra and melanoma. Pfizer knew as early as 1998 that people taking Viagra had dropped out of clinical studies because they had developed cancers that started in the skin or in the tissue lining organs. The complaint cites a Center for Drug Evaluation and Research joint clinical review.

Several Studies show Viagra Melanoma Risks

The master complaint also says that several studies have since found links between the manner in which Viagra works and the development of melanoma cells.

Viagra inhibits the secretion of a specific enzyme that can prevent erection, says the complaint; however, studies over the last few years have found that blocking this enzyme can also trigger the creation of melanoma cells.

84% Increased Risk of Melanoma

A 2014 study, for example, reported that those of the nearly 25,850 participants who had recently used the medication showed an 84 percent increase in the risk of developing or worsening melanoma. That risk was even higher for those who had used Viagra at any time in the past, says the complaint.

Pfizer nevertheless has engaged in a “continuous, expensive and aggressive” advertising campaign – charges the complaint – to promote Viagra since the FDA approved it in 1998. The company made more than $1.8 billion from Viagra sales in 2013, according to the company’s annual report.

The master complaint reads: “As a direct, proximate and legal result of Pfizer’s negligence and wrongful conduct, and the unreasonably dangerous and defective characteristics of the drug Viagra, individual plaintiffs suffered severe and permanent physical and emotional injuries. (These) physical injuries have included melanoma as well as the resulting treatment and surgeries necessitated by the skin cancer diagnosis.”

The master complaint also makes several other allegations that include negligence, unfair and deceptive trade practices, strict liability, breach of express and implied warranty, unjust enrichment, fraud and deceit, and negligent misrepresentation and concealment.

The U.S. Judicial Panel on Multidistrict Litigation consolidated several Viagra lawsuits that bring similar claims.

The suit is In re: Viagra (Sildenafil Citrate) Products Liability Litigation, suit number 3:16-md-02691, in the U.S. District Court for the California Northern District.

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