FDA Clarifies Revatio Child Hypertension Warning

Federal drug regulators fear that a warning about the risks associated with using of the hypertension drug Revatio on children may have been worded too strongly, pushing doctors away from using the medication when it is actually needed.  

On March 31, the FDA issued a clarification to a drug safety communication issued in August 2012 involving the drug Revatio, which is used to treat pulmonary arterial hypertension (PAH).

The original warning stated that the “use of Revatio, particularly chronic use, is not recommended in children,” due to the increased risk of mortality. However, the FDA is now saying that doctors took that warning as a contraindication, believing the agency was calling for Revatio to never be given to children.

While the drug is still not approved by the FDA for treatment in children, the agency said doctors should take into consideration instances where the benefits may outweigh the risks for the child.

Revatio is a phophodiesterase-5 inhibitor, which is manufactured by Pfizer. The medication is commonly used to treat adults with PAH by relaxing the blood vessels in the lungs, allowing blood to flow easily. It is also commonly used to improve the ability to exercise with people who have PAH.

Revatio has commonly been prescribed off-label to help children with high pressure in the blood vessels leading to the lungs improve their ability to exercise.

The 2012 Revatio warning was based on findings from a long-term clinical trial that found the medication may increase a child’s risk of death when administered in high doses’ compared to children taking a lower dosage. The trial also found that under low doses of the drug it does not effectively improve a child’s exercise ability. Other less severe symptoms of taking Revatio may include headache, heartburn, diarrhea and muscle aches.

The clinical trial of Revatio was a double-blind placebo-controlled trial of children between the ages of one and 17 years old who suffer from mild to moderate symptoms of PAH. The majority of the deaths were caused by pulmonary hypertension and heart failure.

PAH causes shortness of breath, dizziness and tiredness, resulting in the right side of the heart working harder than normal due to the constriction of the vessels. Over time this can also result in the enlargement of the right side of the heart. Other symptoms may include ankle or leg swelling and chest pain or pressure.