Revatio (generic: sildenafil) is a prescription medication that is indicated to assist in the treatment of pulmonary arterial hypertension (PAH). Of significant concern, however, are recent studies cautioning the use of Revatio by certain populations. According to a long-term clinical pediatric trial, children under the age of 18 should not take Revatio due to an increased association with catastrophic complications. Unfortunately, those patients may significantly increase their risk of developing pulmonary hypertension and heart failure, which are the most common causes of death in children with PAH.
If you or a loved one has been injured by Revatio, you should contact our lawyers immediately for a free confidential case evaluation. You may be entitled to compensation for your injuries and we can help.
Revatio Lawsuit Overview
Revatio was developed by Pfizer and approved by the U.S. Food and Drug Administration (FDA) on June 3, 2005. Following its release onto the U.S. market, Revatio was indicated to assist in the treatment of pulmonary arterial hypertension (PAH) and improve exercise capacity in both men and women. However, it has also been prescribed to slow down worsening changes in a patient’s physical condition.
Pulmonary arterial hypertension (PAH), otherwise known as high blood pressure of the lungs, is a disease that affects the heart and lungs. Those diagnosed with PAH often experience a significant narrowing of the pulmonary arteries. Severe cases may witness the arteries become completely blocked. As a result, the heart is forced to exert more energy to preform the normal task of pushing blood through the lungs. Eventually the heart becomes overworked and less blood flows through the lungs to pick up oxygen. This results in the symptoms associated with PAH.
Revatio is a phosphodiesterase-5 inhibitor used to treat pulmonary arterial hypertension by relaxing the blood vessels in the lungs to reduce blood pressure and is approved to improve exercise ability and delay clinical worsening of PAH in adult patients. Of significant concern, however, are recent studies cautioning the use of Revatio by certain populations. According to a recent FDA Drug Safety Communication, the use of Revatio by children under the age of 18 may heighten their risk of death. Subsequently, those patients may significantly increase their risk of developing pulmonary hypertension and heart failure. Due to the severity and rate in which these incidents may occur, Pfizer may become the subject of a large Revatio lawsuit.
Revatio Side Effects
Revatio lawsuits are currently evaluating the potential link between the use of this medication and the development of the following side effects:
- Chest pain
- Fainting
- Fast or irregular heartbeat
- Memory loss
- Numb feeling in arms and legs
- One-sided weakness
- Ringing in the ears
- Seizures
- Severe or persistent dizziness
- Severe or persistent vision changes
- Sudden loss of hearing
- Sudden decrease or loss of vision
- Severe allergic reactions
- Death
Revatio Clinical Trial
While current clinical trials are attempting to establish a link between increased mortality rates of children under the age of 18 and the use of this PAH medication, the potential threat of a Revatio lawsuit is looming of Pfizer’s head. One study in particular, looked at 234 patients with PAH under the age of 18. According to an FDA Drug Safety Communication, the primary objective of the trial was to assess the effect of Revatio on exercise capacity as measured by the Cardiopulmonary Exercise Test (CPET) in patients who were developmentally able to perform the test. Patients were then followed for an average of three years.
A direct dose-related effect on mortality was observed with the highest dose having the worst outcome. The hazard ratio for high dose compared to low dose was 3.5 (p=0.015). Deaths were first observed after approximately one year, then occurred at fairly constant rates within each group. Causes of death were typical of patients with pulmonary hypertension.
FDA Warning & Label Change
Revatio has never been approved for the treatment of PAH in children under the age of 18, and in light of the new clinical trial information, off-label (not approved by FDA) use of the drug in pediatric patients is not recommended. As a result, Revatio labels are being revised to include the following:
- A new warning stating the use of Revatio is not recommended in pediatric patients
- Results of the Revatio trial in pediatric patients
Do I Have a Revatio Lawsuit?
The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in Revatio lawsuits. We are currently accepting new cases in all 50 states.
Again, if you or a loved one has been injured by Revatio, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.