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# OPDP Finds ‘False, Misleading’ Addyi Post
- URL: https://www.fdaweb.com/opdp-finds-false-misleading-addyi-post/
- Published: 2025-06-10T12:00:00.000Z
- Updated: 2026-09-14T15:13:59.000Z
- Author: David McFarland
- Tags: Drugs, FDA Policy/General, #legacy-id-D5159328

The CDER Office of Prescription Drug Promotion (OPDP) says the Sprout Pharmaceuticals CEO made a false or misleading post about the company’s Addyi (fibanserin) tablets, for oral use, on her Instagram account. A 5/29 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sprout-pharmaceuticals-inc-709942-05292025?ref=fdaweb.com) says the post made representations about Addyi’s benefits, failed to include any risk information about the drug, and omitted material information about the product’s full indication, including limitations on its use. OPDP says it received Bad Ad Program complaints about the post.

“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 hypertension and syncope in certain settings,” the letter says.

Addyi is indicated to treat premenopausal women with acquired generalized hypoactive sexual desire disorder. The labeling says it is not indicated to treat the disorder in postmenopausal women or men, and is not indicated to enhance sexual performance.

OPDP cites an 8/31/2020 Warning Letter that addressed presentations for Addyi with certain similarities to the post addressed in the current letter. “OPDP is concerned that, despite receiving the previous Warning Letter, Sprout continues to promote Addyi in a similarly misleading manner,” the letter says.

OPDP also says the post was not submitted to FDA at the time of its initial dissemination or publication, as required by law.

Sprout was told to respond with a list of all other promotional communications for Addyi that contain representations such as those described in the letter and a plan to discontinue such communications or cease distribution of the drug. It also is to provide a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective communications about the concerns discussed in the letter to audiences that received the violative communication.