Revatio, a prescription medication used to treat pulmonary arterial hypertension (PAH), has recently been linked to an increased risk for skin cancer, specifically melanoma.
Free Confidential Lawsuit Evaluation: If you or a loved one was diagnosed with melanoma after taking Revatio, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.
What is Revatio?
First approved by the U.S. Food & Drug Administration (FDA) in June 2005, Revatio (generic: sildenafil citrate) is used to treat pulmonary arterial hypertension in adults by relaxing blood vessels in the lungs to reduce blood pressure, which is supposed to improve exercise ability and delay clinical worsening of the condition. In Nov. 2009, FDA approved an intravenous formulation of Revatio for the treatment of PAH.
Revatio Skin Cancer
A study published in JAMA Internal Medicine in June 2014 found that men who took sildenafil (the active ingredient in Revatio) were 84% more likely to develop melanoma, regardless of their family histories of cancer, medical histories, or sun exposure where they lived. The researchers suggested that sildenafil may lead to melanoma (as opposed to less invasive forms of skin cancer) because the medicine affects the same genetic pathways that allow skin cancers to become more aggressive.
- Mole on the skin that grows, changes shape or turns different colors
- Mole that looks scaly, oozes or starts bleeding
- Dark spot on the skin that looks like a mole, but grows rapidly
- Pain, itch, or bleeding in a newly-formed spot on the skin
- Streak underneath a fingernail or toenail
- Bruise on the foot that does not heal
Revatio vs. Viagra
Revatio (sildenafil 20 mg) is the exact same drug as Viagra, just in a different dose. Viagra comes in 3 different dosages of 25 mg, 50 mg and 100 mg. Revatio became available as a generic medication in 2013.
FDA Warns Against Use of Revatio on Children
In August 2012, FDA issued a warning today notifying healthcare professionals and their medical organizations that Revatio should not be prescribed to children under the age of 18 for the treatment of pulmonary arterial hypertension. However, when Revatio is given to children for this purpose, it is an ‘off-label’ use for which it has been neither tested nor approved by the FDA, and a new warning has been added to the drug’s label stating that Revatio is not recommended in pediatric patients.
FDA’s warning against the pediatric use of Revatio was based on a recent long-term study which found that children taking a high dose of the drug had an increased risk of death compared to those taking a lower dose, and that low doses of Revatio are not effective in improving exercise ability.
Revatio is an FDA-approved prescription phosphodiesterase (PDE) inhibitor. Drugs from this class block an enzyme called phosphodiesterase type-5 (PDE5), which is thought to be responsible for breaking down a chemical in the lungs that causes blood vessels to relax. By blocking PDE5, Revatio makes more of this chemical available, which allows blood to flow more easily through the lung’s vessels. Revatio is designed to help relieve the symptoms of PAH, which can improve users’ ability to exercise and delay a significant event that could potentially worsen their condition. The maximum recommended dose of Revatio for adult patients with PAH is 20 mg three times a day.
FDA is advising patients and caregivers not to change the Revatio dose or discontinue treatment with the drug without first consulting their physician. Healthcare professionals should keep in mind that when given to children, Revatio is not approved by the FDA, is being used off-label, and is not recommended.
Revatio Side Effects
The sildenafil contained in Revatio has been associated with a number of severe side effects, which may include:
- chest pain
- fast or irregular heartbeat
- memory loss
- numbness of an arm or leg
- one-sided weakness
- ringing in the ears
- severe or persistent dizziness
- severe or persistent vision changes
- sudden decrease or loss of hearing
- sudden decrease or loss of vision in one or both eyes
- severe allergic reactions
Minor side effects of sildenafil may include:
- stuffy nose
- upset stomach
Do I Have a Revatio Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Revatio lawsuits. We are handling individual litigation nationwide and currently accepting new melanoma skin cancer cases in all 50 states.
Free Case Evaluation: Again, if you got melanoma from Revatio, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.