Maker of Sexual Desire Drug Addyi Gets FDA Warning Letter

 Sprout Pharmaceuticals failed to include drug risk information in a promotional social media post, the FDA said in a warning letter

opens in a new tab or window posted on Tuesday.

The agency said the company's CEO Cindy Eckert included a "false or misleading" post on her personal Instagram account that describes the benefits of flibanserin (Addyi) but "entirely omits risk information."

"These violations are concerning from a public health perspective because the promotional communication creates a misleading impression regarding the safety and effectiveness of Addyi, a drug with a number of serious risks, including a boxed warning due to the risk of severe hypotension and syncope in certain settings," the letter noted.

The Instagram post was not submitted to the FDA for review, which is required for any drug labeling or promotional advertising.

According to the warning letter, dated May 29, Sprout has 15 business days to respond in writing. The social media post in question is still live as of today.

This wasn't the first time Sprout was reprimanded by the FDA. It previously received a letter in August 2020 for a radio ad that similarly omitted important drug risk information and its limitations of use, "thus creating a misleading impression about the safety and approved use of the drug," the letter stated.

The Office of Prescription Drug Promotion "is concerned that, despite receiving this previous Warning Letter, Sprout continues to promote Addyi in a similarly misleading manner," it added.

Approved in 2015, flibanserin is indicatedopens in a new tab or window for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). It's not indicated for HSDD caused by a co-existing medical or psychiatric condition, problems within relationships, or the effects of a medication or other drug substance. It's also not intended for use in postmenopausal women or in men, nor to enhance sexual performance.

The drug's labelopens in a new tab or window carries a boxed warning regarding alcohol useopens in a new tab or window that can increase the risk of severe hypotension and syncope. Flibanserin is contraindicated in patients using concomitant moderate or strong CYP3A4 inhibitors, in patients with hepatic impairment, and in patients with known hypersensitivity to it or any of its components.

https://www.medpagetoday.com/obgyn/generalobgyn/116011