Addyi: FDA stop a...“Listen up! Sexual dysfunction isn’t just a ‘man’ thing.”

 

On August 31, 2020, the United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued the third enforcement letter of 2020. The warning letter, sent to Sprout Pharmaceuticals, Inc., for its flibanserin tablets (Addyi), takes issue with Sprout’s direct-to-consumer (DTC) radio advertisement. According to OPDP, the radio ad made false or misleading claims about the risks associated with Addyi and omits other material facts.

Ver:

26:0 Frente a una FDA "sexista"..."Women’s Sexual Health Equity " y Sprout.

The radio ad begins with an exclamation, “Listen up! Sexual dysfunction isn’t just a ‘man’ thing.” The voiceover goes on to say that one in 10 premenopausal women “suffer from frustrating low libido, also known as HSDD. That’s a lot of women in your cycle class just spinning their wheels.” It goes on to characterize Addyi as “an FDA-approved pill for women frustrated by their low libido,” and outlines both how to access the company’s website for a medical consultation and how to get the drug with minimal or no out-of-pocket costs.

 

 https://addyi.com/howtosave/

OPDP notes that the violations by Sprout “are concerning from a public health perspective because they create a misleading impression about the safety and effectiveness of Addyi, a drug that bears a Boxed Warning due to the risk of severe hypotension and syncope in certain settings.”

OPDP also raised concern that Sprout was promoting Addyi “in a manner that does not adequately convey the FDA-approved indication nor the important risk information for the drug.”

The radio ad included numerous claims and presentations regarding the benefits of using Addyi for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women but it “completely omits all the contraindications associated with the use of Addyi.” The radio ad also “fails to disclose material information from the Boxed Warning that the use of Addyi and alcohol together close in time increases the risk of severe hypotension and syncope.” The letter cites the example of the Boxed Warning and Medication Guide both say patients should wait at least two hours after drinking 1 or 2 standard alcoholic drinks before taking Addyi at bedtime, but the radio ad makes no mention of such a suggestion.

The radio ad also omits material information from the Boxed Warning that the use of Addyi with certain prescription medications or in patients with liver problems increases the risk of severe hypotension and syncope.

OPDP requested that Sprout “immediately cease misbranding Addyi and/or cease introducing the misbranded drug into interstate commerce.” In addition to requesting a list of promotional materials that include statements such as the ones described in the letter, OPDP requested that the response include a “comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective messages about the issues discussed in this letter to the audience that received the violative promotional material.”