Adcirca contains tadalafil, a drug that is linked to a 21% higher risk of melanoma skin cancer. Eli Lilly & Co. is facing hundreds of lawsuits for failing to warn about this deadly side effect.
What is Adcirca?
Adcirca® is an oral prescription medication that is approved to improve exercise ability in adults with Pulmonary Arterial Hypertension (PAH), a condition that causes high blood pressure in the lungs. Adcirca was approved in 2003 and it is manufactured by Eli Lilly & Co.
How Does Adcirca Work?
Adcirca contains tadalafil, the same active ingredient as Cialis, a drug for men with erectile dysfunction that is also sold by Eli Lilly. These drugs improve blood-flow to parts of the body by inhibiting an enzyme called phosphodiesterase 5 (PDE5). They improve circulation by relaxing smooth muscles in the walls of blood vessels.
What is the problem?
Studies have shown that people who use tadalafil and other PDE5 inhibitors, such as Viagra (sildenafil), have a higher risk of aggressive melanoma skin cancer. The problem is that about 50% of melanomas naturally inhibit PDE5 and these melanomas are more aggressive.
What is the Risk?
Tadalafil was specifically linked to a 21% increased risk of melanoma in a study published by the Journal of the American Medical Association (JAMA) in 2015. The year before, Harvard researchers found an 84% increased risk of melanoma.
Earlier studies suggest that PDE5 inhibitor medications like Adcirca might make melanoma grow more quickly and spread to other organs. For example, a study in 2011 found a “dramatic increase in melanoma cell invasion.” A study in 2012 found that PDE5 inhibitors promoted the synthesis of melanin, which could fuel fast-growing skin cancer.
Adcirca Melanoma Risk Under FDA Review
In July 2016, the FDA announced that it was evaluating the need for regulatory action into a possible association between Acirca and melanoma skin cancer. The agency is also investigating Viagra, Cialis, Levitra, Revatio, Staxyn, and Stendra.
Have Lawsuits Been Filed?
Yes. Hundreds of lawsuits have been filed by men with melanoma who took tadalafil. They accuse Eli Lilly & Co. of failing to warn about the possible risk of skin cancer from Cialis. The lawsuits are not part of a class action. Instead, they are individual lawsuits that are centralized into one federal court.
This nationwide litigation is overseen by U.S. District Judge Richard Seeborg in the Northern District of California — Multi-District Litigation (MDL No. 2691) — In RE: Viagra and Cialis Products Liability Litigation.
What is Melanoma?
Melanoma is the most dangerous and deadliest type of skin cancer. It is usually very aggressive and grows quickly. An estimated 90,000 new cases of melanoma will be diagnosed in 2017.
Signs & Symptoms of Melanoma Skin Cancer
Skin cancer can start anywhere on the body. Melanoma may look like a harmless mole in its early stages, which can delay diagnosis until it is impossible to cure. Warning signs of melanoma skin cancer include:
- Asymmetrical shape
- Uneven border
- Multiple colors
- Larger than a pencil eraser (1/4 inch)
- Changes over time
- Looks and feels different from other moles
- Bleeding or crusting
- Pain or tenderness