Revatio Lawsuit
Revatio is a prescription medication used to treat pulmonary arterial hypertension but has been linked to causing an increased risk of melanoma; a deadly skin cancer.
What is Revatio?
Revatio (sildenafil) is a drug used in the treatment of pulmonary arterial hypertension (PAH). It is a member of the Phosphodiesterase (PDE)-5 inhibitor drug family). It comes in tablet, oral suspension, and injection forms.
Revatio 20 mg Tablets
Revatio is manufactured by Pfizer and was approved by the Food and Drug Administration in 2009. Revatio is a once daily treatment, averaging around $200 per prescription.
In June 2016, the FDA announced that it was evaluating the need for regulatory action regarding Phosphodiesterase (PDE)-5 inhibitor drugs such as Revatio. This warning came in response to recent reports linking drugs like Revatio to an increased risk of melanoma.
What is Melanoma?
Melanoma is the most deadly form of skin cancer. Each year, the disease claims over 10,000 lives in America. The cancer is characterized by an abnormal growth, discoloration or jaggedness of new or existing moles. Melanoma is most often caused by prolonged exposure to sunlight or ultraviolet lamps (such as those found in tanning beds).
Revatio and Melanoma
Melanoma is generally characterized by a new or unusual mole growth. A typical, healthy mole is usually an evenly brown or tan color with a diameter of no more than 6mm. Most moles are generally present from birth, although new moles can develop throughout a person’s life. If a mole becomes extremely dark, misshapen, or red it may be considered abnormal.
It is important to visit a doctor if you notice a growth or any abnormality in skin texture or complexion. Physicians recommend the “ABCDE” checklist of symptoms to determine if a doctor’s visit is necessary:
- Asymmetry
- Borders (irregular with edges and corners)
- Color (variegated)
- Diameter (greater than 6 mm (0.24 in), about the size of a pencil eraser)
- Evolving over time
If any of these symptoms are present, contact your doctor immediately.
What are the side effects of Revatio?
Revatio is associated with a variety of health risks. Below is a list of side effects associated with the use of Revatio (sildenafil). If you experience any of these side effects, contact your health care provider immediately.
Serious Side Effects
- Sudden vision loss
- Ringing in your ears or sudden hearing loss
- Chest pain or radiating pain in torso and limbs
- Irregular heartbeat
- Swelling in your hands, feet or ankles
- Shortness of breath
- Vision changes, including blue tint
- Lightheadedness
- Erection lasting more than 4 hours
Common Side Effects
- Warmth or redness in your face, neck, or chest
- Stuffy nose
- Headache
- Memory problems
- Upset stomach
- Back pain
- Nervousness
- Pain or discomfort in joints
- Pounding in the ears
- Shortness of breath
Revatio Vs. Viagra
Revatio and Viagra are both manufactured and marketed by Pfizer. Both of the drugs contain the active ingredient sildenafil, a PDE-5 inhibitor. Viagra is used in the treatment of erectile dysfunction, while Revatio is used to treat pulmonary arterial hypertension (PAH).
Sildenafil was initially studied for treatment of PAH. However, researchers soon noticed that men taking the drug were able to achieve and maintain penile erection, even with diagnosed erectile dysfunction. Marketing and research efforts soon shifted and Viagra was introduced to the market in 1998. Revatio was approved for the treatment of PAH in 2009. Reports may have shown that all PDE5-inhibitor type drugs cause an increased risk in developing melanoma.
Revatio and the FDA
The Food and Drug Administration announced it would be conducting an independent review of PDE-5 inhibitor drugs (such as Revatio) and their link to melanoma. This comes after intense public scrutiny to explore the link between erectile dysfunction and PAH drugs to the deadly skin cancer. An often cited study, published in the medical journal JAMA, showed an increased risk of up to 20% in developing melanoma when taking PDE5 inhibitors.
Revatio Melanoma Lawsuit
A number of men are thought to be at risk of melanoma after taking PDE5 inhibitor drugs including Revatio. Many of the men and families affected by the adverse effects have opted to contact law firms like ours to investigate the possibility of filing a lawsuit against the drug’s multi-billion dollar manufacturer, Pfizer.