U.S. health regulators are warning against the use of Pfizer’s pulmonary arterial hypertension (PAH) drug Revatio (generic: sildenafil citrate) in children. On August 30, 2012, the U.S. Food & Drug Administration (FDA) recommended against using Revatio in children up to 17 years of age, saying it had a higher risk of death when taken in high doses. While the drug has never been approved for the treatment of PAH in minors, the FDA is warning against its so-called ‘off-label’ use for this purpose, for which it has been neither tested nor approved by the administration.
Free Revatio Lawsuit Evaluation: If your child or other loved one was injured by Revatio, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.
FDA Warning on Revatio
The FDA’s warning on Revatio was prompted by the results of a recent long-term clinical study which found that minors taking high doses of the drug were at an increased risk of sudden, accidental death compared to users who took lower doses. The research also determined that low doses of Revatio had little if any effectiveness in improving exercise ability. The warning went on to state that Revatio treatment in patients under the age of 18 was off-label, and that new drug labels will state that Revatio is not recommended for use in children.
How Does Revatio Work?
Revatio, which contains sildenafil, the main active ingredient found in Viagra, is an FDA-approved prescription phosphodiesterase (PDE) inhibitor drug. PDE medications block a critical enzyme which is thought to be responsible for breaking down a chemical in the lungs that causes blood vessels to relax. By blocking this enzyme, Revatio allows blood to flow more easily through the lung’s vessels. The drug is approved for use in adults suffering from PAH, and is designed to improve patients’ ability to exercise, as well as to delay significant events that could potentially worsen their condition. The maximum recommended dose of Revatio for adult users is 20 mg. three times a day.
In its warning, the FDA advises patients and caregivers not to alter the dose or discontinue treatment with Revatio without first consulting the prescribing doctor. The press release concludes by emphasizing the fact that Revatio is not approved for children, and any doctor that prescribes it for this use is doing so off-label. This practice is not recommended by the U.S. Food & Drug Administration.
Do I Have a Revatio Lawsuit?
The Product Liability & Defective Drug 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 Revatio injury lawsuits in all 50 states.
Free Revatio Lawsuit Evaluation: Again, if your child or other loved one suffered a serious injury after being treated with Revatio, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.