If your child died or suffered serious side effects while being treated with Revatio, you may be eligible to file a Revatio lawsuit.  Revatio (sildenafil), a medication prescribed for the treatment of pulmonary arterial hypertension (“PAH”), has been linked to an increased risk of death in children.  Revatio is a phosphodiesterase-5 inhibitor used to treat PAH by relaxing the blood vessels in the lungs to reduce blood pressure as well as to improve a patient’s ability to exercise and also to delay worsening of the disease.  Although Revatio was approved by the U.S. Food and Drug Administration (“FDA”) in 2005 to treat adults suffering from PAH, it has never been approved to treat PAH in children.  Using this drug for pediatric cases is considered an off-label use, and could therefore make you eligible to file a Revatio lawsuit if your child was prescribed the medication. Based on the results of a recent long-term clinical pediatric trial, on August 30, 2012, the FDA issued a drug safety communication recommending that Revatio not be prescribed to children between the ages of 1 and 17 for the treatment of PAH.  The clinical trial showed:

  • children taking a high dose of Revatio had a higher risk of death than children taking a low dose; and
  • low doses of Revatio are not effective in improving exercise ability.

Further, the FDA drug safety communication also stated that the findings of the clinical trial revealed that most deaths were caused by pulmonary hypertension and heart failure, which are the most common causes of death in children with PAH. In summarizing the study’s findings, the FDA found a direct dose-related effect on mortality in children who received the highest doses.  Deaths were first observed after year one, and then occurred at fairly constant rates within each group. If your child was one of the many who received the highest doses, you should consider pursuing a Revatio lawsuit.

The Revatio injury lawyers at Bernstein Liebhard LLP are currently evaluating claims related to Revatio injuries and/or death in children.  If your child died or suffered serious injuries as a result of being treated with Revatio, contact our firm today for a free case review.  You may be able to file a Revatio lawsuit seeking compensation from Pfizer, the manufacturer of the medication.

Revatio Injuries And Death Risk Lead To New FDA Warning Label

In addition to issuing the drug safety communication, the FDA has also added the following information to the drug’s label to warn consumers about Revatio injuries in children.  The updated information includes:

  • A new warning stating that the use of Revatio is not recommended in pediatric patients; and
  • Results of the Revatio trial in pediatric patients.

Although doctors can generally prescribe medications off-label for any treatment they see fit, the updated information, which has been added to Revatio’s labeling, sends a clear message that the risks of treating children with Revatio clearly outweigh any possible benefits.

Further, given that the effect of Revatio on the risk of death with long-term use in adults is unknown, in light of these recent findings, the FDA is requiring Pfizer to evaluate Revatio’s effect on the risk of death in adults suffering from PAH.

Sildenafil, the active ingredient in Revatio, is also contained in the widely prescribed sexual enhancement drug Viagra, which is used to treat erectile dysfunction or impotence in men.  At this time, the FDA “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.”

Contact A Revatio Injury Lawyer Today

If your child died or suffered serious injuries as a result of being treated with Revatio, you may be able to file a lawsuit seeking compensation for medical expenses, pain and suffering, and other injuries.  The Revatio injury attorneys at Bernstein Liebhard LLP have extensive litigation experience, and have recovered billions of dollars on behalf of their clients.  In addition to being staunch advocates for you claim, we provide personal attention to guide you through the complex litigation complex.

Contact one of our attorneys if you are considering pursuing a Revatio lawsuit today at (877) 779-1414.

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Published September 5, 2012 by