Link to Death in Children Likely to Cause Revatio Lawsuits to Mount
If your child suffers from pulmonary arterial hypertension (PAH), the U.S. Food and Drug Administration is warning you: don’t take Revatio. But if you already have, and your child suffered serious side effects or even died, you may be eligible to file a Revatio lawsuit.
Following a period of long-term clinical testing, the FDA revealed on Aug. 30, 2012 that higher doses of the drug might lead to an elevated risk of death in pediatric patients, and should not be prescribed to children between the ages of 1 and 17. As was found in the study, deaths were seen after the first year and continued at a fairly constant rate within each group after that.
As part of a safety communication issued by the FDA, experts concluded that most deaths from Revatio were caused by pulmonary hypertension and heart failure, which are already the most common causes of death in children with PAH. What’s more, low doses of Revatio were shown to be ineffective in improving exercise ability in pediatric patients.
The most frightening part of these discoveries is that the drug, also known as sildenafil, was only approved by the agency in 2005 to improve exercise ability and lessen symptoms of PAH in adult patients. That said, prescribing Revatio in children has been considered an off-label use since then.
The risk of death caused by the Pfizer-manufactured drug in adults has also not yet been determined. That’s why, as part of the recent recommendation, the FDA is requiring that Pfizer investigate this potentially harmful connection. Revatio’s current label recommends that all patients avoid doses higher than 20mg.
The FDA is requiring that Revatio’s label be revised to include a warning against prescribing the PAH-drug to children.
The agency’s recent recommendation is likely to raise questions in the medical community about the connection between death and Viagra, another popular drug whose main ingredient is sildenafil. In addressing this concern, the FDA said it “does not believe that this safety concern applies to the use of Viagra, given the differences in patient population and the different recommended dosing regimens.”