FDA Warns that Revatio Not for Children

Aug. 31, 2012 - PRLog -- Ennis & Ennis, P.A. is investigating cases where children were harmed by Revatio.  On August 30, 2012 the U.S. Food and Drug Administration (FDA) issued a Safety Communication 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).  [1].  This Communication was promoted by a recent clinical trial involving children that revealed increased risk of death in high doses and ineffectiveness in improving exercise ability in low doses.  [2].  Most deaths were caused by pulmonary hypertension and heart failure.

Revatio is FDA approved to improve exercise ability and delay clinical worsening of PAH in adult patients, but has never been approved for treatment of PAH in children.   The current Revatio label recommends avoiding doses higher than 20mg 3x/day in adults.  The effect of Revatio risk of death with long-term use in adults is unknown and the FDA is requiring the manufacturer, Pfizer, to evaluate that specific risk.

Patients and caregivers are advised to not change the Revatio dose or stop taking Revatio without talking to a health care professional. Healthcare professionals were reminded that use of this product, particularly chronic use, in children is an off-label indication, not approved by FDA, and is not recommended.

Ennis & Ennis, PA is investigating Revatio cases where children have suffered pulmonary hypertension or heart failure and is offering free nationwide confidential consultations by calling toll free 1-800-856-6405 or by going to www.ennislaw.com and completing an online case evaluation form.

Ennis & Ennis, P.A. is a nationwide law firm with offices in Ft. Lauderdale, Miami and Washington D.C. that concentrates its practice in mass torts and represents individuals against pharmaceutical companies as well as medical device makers.

Ennis & Ennis, P.A. has been representing clients individually since 1986 and has recovered over $100 million in settlements for its clients.

Ennis & Ennis, P.A. is also investigating cases involving Actos, Fosamax, Plavix, Paxil, Zoloft, Prozac, GranuFlo Dialysis, Depuy Hip Recall, Wright Conserve Hip Devices, Wright Profemur Hip Devices, Zimmer Hip Recall, Medtronic Infuse Bone Graft, Depakote, Reglan, SJS/Dilantin, Yaz, Yasmin, Ocella Birth Control Pills, and Transvaginal Mesh Devices.

Remember the law limits the time in which you can file a claim, so don't wait to explore your legal rights.  Call today toll free 1-800-856-6405 or visit www.ennislaw.com.

[1] http://www.fda.gov/Drugs/DrugSafety/ucm317123.htm#.UEC7TH...
[2] http://www.ncbi.nlm.nih.gov/pubmed/22128226