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

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