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FDA Recommends Against Use of Revatio In Children With Pulmonary Hypertension

Children using Revatio for pulmonary arterial hypertension may be at a much higher risk of death due to pulmonary hypertension or cardiac events such as heart failure. If you or a loved one have been injured as a result of Revatio side effects you may be entitled to compensation. Contact the Revatio side effects lawsuit attorneys of Ennis & Ennis, P.A. today for a free, confidential Revatio side effects case evaluation.

The U.S. Food and Drug Administration (FDA) is recommending that Revatio (sildenafil) not be prescribed to children (ages 1 through 17) for pulmonary arterial hypertension (PAH; high pressure in the blood vessels leading to the lungs).  This recommendation against use is based on a recent long-term clinical pediatric trial showing that: (1) children taking a high dose of Revatio had a higher risk of death than children taking a low dose and (2) the low doses of Revatio are not effective in improving exercise ability.1   Most deaths were caused by pulmonary hypertension and heart failure, which are the most common causes of death in children with PAH.

Revatio has never been approved for the treatment of PAH in children, 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. The following new information is being added to the Revatio drug label:

  • A new warning stating the use of Revatio is not recommended in pediatric patients.

  • Results of the Revatio trial in pediatric patients.

Revatio is approved to improve exercise ability and delay clinical worsening of PAH in adult patients (WHO Group I).  The current Revatio label recommends avoiding doses higher than 20 mg, given three times a day.  The effect of Revatio on the risk of death with long-term use in adults is unknown; FDA is requiring the manufacturer of Revatio (Pfizer) to evaluate Revatio’s effect on the risk of death in adults with PAH.

Additional Revatio Side Effects Lawsuit Information For Patients

  • DO NOT change your Revatio dose or stop taking Revatio without talking to your healthcare professional.

  • Discuss any questions you have about Revatio with your healthcare professional.

  • Report any side effects you experience to the FDA MedWatch program using the information.

  • Contact the Revatio Side Effects Lawsuit Attorneys of Ennis & Ennis, P.A. today for a free, confidential, Revatio injury case evaluation by filling out the form on this page or calling one of our Revatio lawyers toll free at: 1.800.856.6405.

Additional Revatio Side Effects Information For Healthcare Professionals

  • Use of Revatio, particularly chronic use, is not recommended in children. An unexpectedly higher risk of mortality was found in pediatric patients taking a high dose of Revatio when compared to pediatric patients taking a low dose.

  • The maximum recommended dose of Revatio for adult patients with PAH is 20mg three times per day.

Revatio Side Effects Information

In a randomized, double-blind, multi-center, placebo-controlled, parallel-group, dose-ranging clinical trial, 234 patients with PAH, 1 to 17 years of age, were randomized to low-, medium-, or high-dose Revatio (sildenafil; administered three times per day) or placebo for 16 weeks of treatment. Most patients had mild to moderate symptoms at baseline. Actual doses administered were dependent on body weight.

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 (n = 115). Administration of Revatio did not result in a statistically significant improvement in exercise capacity in those patients.

After completing the 16-week controlled clinical trial, patients randomized to Revatio remained on the same dose of Revatio; patients originally randomized to placebo were re-randomized to low-, medium-, or high-dose Revatio. After all patients completed 16 weeks of follow-up in the controlled clinical trial, the blind was broken and doses were adjusted as clinically indicated. Patients were followed for a mean of 3 years (range 0 to 7 years). Mortality during the long-term clinical trial, as a function of originally assigned dose.

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 about 1 year, then occurred at fairly constant rates within each group.  Causes of death were typical of patients with pulmonary hypertension.

In light of these risks, the use of Revatio is not recommended in children. A new warning against the use of Revatio in pediatric patients is being added to the Revatio drug label.

References

  1. Barst RJ, Ivy DD, Gaitan G, et al. A randomized, double-blind, placebo-controlled, dose-ranging study of oral sildenafil citrate in treatment-niave children with pulmonary arterial hypertension. Circulation 2012;125:324-334.
Revatio Lawsuit News Archive::

Free Revatio Side Effects Lawsuit Case Evaluation

If you or a loved one have suffered serious Revatio side effects, suffered a loss due to Revatio Cardiac Side Effects or have been injured as a result of a Revatio use you may be entitled to compensation. Contact the Revatio Recall Injury Lawyers of Ennis & Ennis today for a free confidential case evaluation by filling out the form on this page or call toll-free: 1-800-856-6405.

Ennis & Ennis, P.A. is currently handling cases for Revatio Pulmonary Hypertension Use:

Revatio Recall

Revatio Off Label Pediatric Use

Revatio Pediatric Pulmonary Hypertension Use

Revatio Side Effects Lawsuit

Revatio Pediatric Side Effects Lawsuit

Revatio Child Death Lawsuit


If you or a loved one have suffered serious Revatio side effects (Sildenafil side effects), suffered the loss of a child due to Revatio Cardiac Side Effects or have been injured as a result of a Revatio prescription you may be entitled to compensation. Contact the Revatio Recall Lawyers of Ennis & Ennis today for a free confidential case evaluation by filling out the form on this page or call toll-free:1-800-856-6405.

 

 

 

 

 

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