FDA Issues Warning on Revatio and Children
A new study by 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 (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,” U.S. Food and Drug Adminhttp://www.fda.gov/Drugs/DrugSafety/ucm317123.htmistration.
What is Revatio?
- Revatio is a phosphodiesterase-5 inhibitor used to treat pulmonary arterial hypertension by relaxing the blood vessels in the lungs to reduce blood pressure.
- Revatio is also used in the prescription product Viagra, a drug for adult males with erectile dysfunction (inability to get or maintain an erection), but the FDA doesn’t believe that this safety concern applies to the use of Viagra, given the differences in patient population and the different recommended dosing regimens.
- Reavtio is not approved for use in children.
How does Revatio affect Children?
- In a recent FDA study, Revatio caused deaths by pulmonary hypertension and heart failure, the most common causes of death in children with PAH.
- The new FDA clinical trial determined that off-label (or not approved by FDA) use of the drug in pediatric patients is not recommended.
- The FDA is adding new information to the drug label; the new info will let consumers know that Revatio is not recommended in pediatric patients.
- Revatio is approved (by the FDA) to improve exercise ability and delay clinical worsening of PAH in adult patients. The FDA is requiring the manufacturer of Revatio (Pfizer) to evaluate its effect on the risk of death in adults with PAH.
Important Information for Revatio Users
The FDA recommends the following:
- Do not change your Revatio dose or stop taking Revatio without talking to your health care professional.
- Discuss any questions you have about Revatio with your health care professional.
- Report any side effects you experience to the FDA MedWatch program.
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