FDA Issues Year’s First Warning Letter for DTC Ad

The FDA’s Office of Prescription Drug Promotion issued a warning letter to Metuchen Pharma over misleading claims in a print advertisement for its erectile dysfunction drug Stendra (avanafil).

The direct-to-consumer ad claimed the tablets “can treat ED and reduce risk of heart failure with a PDE-5 inhibitor,” but the agency noted the drug isn’t approved for reducing the risk of heart failure.

The ad also misled patients by claiming the drug is “safe and effective for those with heart diseases.” The agency said patients could misinterpret the phrase to mean that the drug is safe for all patients with heart disease, including those with heart failure, when there is only evidence that the drug may be safe and effective for men with some types of the disease.