Revatio/Sildenafil High Risk of Death & Injury. Revatio (sildenafil), a medication used to treat pulmonary arterial hypertension (PAH), is associated with a high rate of death when used in children. In August 2012, the U.S. Food & Drug Administration (FDA) warned doctors not to use Revatio in children (under age 17), after a study found that high doses of ‘Revatio’ in children was associated with an unexpectedly high risk of death from pulmonary hypertension and heart failure. The FDA also reminded doctors that ‘Revatio’ had never been approved to treat PAH in children.
Child Death by Revatio that Caused by Pulmonary Hypertension or Heart Failure
If your child died during treatment with Revatio, especially from pulmonary hypertension or heart failure, you may be entitled to compensation from Pfizer, the maker of this drug.
The ‘Revatio’ injury lawyers at Parker Waichman LLP are investigating side effects associated with this medication, and are offering free lawsuit consultations to ‘Revatio’ victims. If you want to hold Pfizer accountable for your child’s pain and suffering, we urge you to contact the ‘Revatio’ injury lawyers at Parker Waichman LLP today.
Revatio Not Approved By FDA to Treat PAH in Children, Warning Label Updated
Revatio, which contains the same active ingredient – sildenafil – found in the erectile dysfunction drug, Viagra, is approved to improve the ability to exercise in people with pulmonary arterial hypertension, or PAH. Also known as high blood pressure of the lungs, PAH worsens over time and is life-threatening because of the strain the condition places on the heart.
There is no cure for PAH, but several medications, including Revatio, are available to treat symptoms.
Revatio was never approved by the FDA to treat PAH in children, and using the drug for this purpose is known as an off-label use. Doctors are free to use FDA approved drugs in any way they see fit, including for off-label purposes.
However, drug makers are legally barred from promoting or marketing drugs for off-label uses.
In August 2012, the FDA issued a Drug Safety Communication warning doctors not to use ‘Revatio’ in children, after a clinical trial studying the use of the drug in patients between the ages of 1 and 17 found that high doses of ‘Revatio’ were associated with an unexpectedly high rate of death. Most of the deaths were the result of pulmonary hypertension and heart failure, which are the most common causes of death in children with PAH. According to the FDA, low doses of ‘Revatio’ were not shown to be effective in improving exercise ability.
As a result of the study’s findings, the ‘Revatio’ label was updated to include:
- A new warning stating the use of Revatio is not recommended in pediatric patients
- Results of the ‘Revatio’ trial in pediatric patients
The FDA also noted in its Drug Safety Communication that the effect of ‘Revatio’ on the risk of death with long-term use in adults is unknown. The agency is requiring Pfizer to evaluate Revatio’s effect on the risk of death in adults with PAH.
Legal Help for Victims of Revatio Side Effects
If your child was injured by Revatio side effects, you may have valuable legal rights. For your free lawsuit evaluation with one of our Revatio injury lawyers, please fill out our online form, or call 1-800-YOURLAWYER (1-800-968-7529) today.