Sept. 21, 2020 – A radio ad that promotes the benefits of a product but omits all of the contraindications associated with its use creates “a misleading impression about the drug’s safety,” according to an FDA Office of Prescription Drug Promotion (OPDP) Warning Letter issued recently to Sprout Pharmaceuticals Inc. for ADDYI®, a female libido drug that bears a Boxed Warning due to the risk of severe hypotension and syncope.

In its Aug. 31 Warning Letter, OPDP states that although the Boxed Warning for Addyi, indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), spells out the contraindications and risks of the product, but that the radio ad “fails to provide material information about the consequences that may result from the use of the drug.”

Among these risks are statements that the use of alcohol and Addyi in close proximity increases risks. According to STAT, the FDA “softened a warning” about alcohol and Addyi in 2019, but also “rebuked the company for insisting the warning should be removed.”

Further, the Addyi radio spot, which was submitted to OPDP under Form FDA 2253, makes claims about the use of the product that create a misleading impression and fails to adequately communicate the indication and limitations of use associated with Addyi, the Warning Letter states. “This is particularly concerning given the serious risks of this product and the suggestion that Addyi is approved for all women ‘frustrated by their low libido’ when this is not the case.”

The FDA previously sent advisory comments in August 2016 to Valeant Pharmaceuticals – the company to whom Sprout had sold Addyi but from which they bought it back – about Addyi, and in the current enforcement letter OPDP states its concern that “Sprout is continuing promotion of Addyi in a manner that does not adequately convey the FDA-approved indication nor the important risk information for the drug.”

In its recent letter, the second Warning Letter issued in 2020 and the third enforcement letter of the year overall, OPDP asks Sprout to list in its response to the enforcement action “all promotional materials (with the 2253 submission date) for Addyi that contain statements” such as those described in the Aug. 31 letter.