In August 2012, the Revatio drug label was revised with an added warning that stated “use of Revatio, particularly of chronic use, is not recommended in children.” This recommendation was based on data from a long-term clinical trial in pediatric patients that showed increasing mortality with increasing Revatio doses.
Although Revatio is approved only to treat PAH in adults, healthcare providers must consider whether the benefits of treatment are likely to outweigh the risks for each patient. The Agency noted that there may be circumstances in which the benefit-risk profile of Revatio may be acceptable in individual children, if other treatment options are limited.
The recommendation from August 2012 was not intended to suggest that Revatio should never be prescribed for pediatric use. Some healthcare providers have misinterpreted the information as a contraindication and have refused to prescribe the drug.
The Agency is not changing its initial recommendation nor the evidence behind it, but is seeking to clarify the strength of the warning as stated in the drug label.
Revatio, a phosphodiesterase-5 inhibitor, is used to treat pulmonary arterial hypertension by relaxing the blood vessels in the lungs to reduce blood pressure and is approved to improve exercise ability and delay clinical worsening of PAH in adult patients.
For more information call (888) 463-6332 or visit the FDA Safety Alert page.