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# Afrezza Facebook Post False, Misleading: OPDP
- URL: https://www.fdaweb.com/afrezza-facebook-post-false-misleading-opdp/
- Published: 2018-10-16T12:00:00.000Z
- Updated: 2026-09-15T00:38:33.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142596

The CDER Office of Prescription Drug Promotion (OPDP) says a Facebook post and associated comments on MannKind’s Afrezza (insulin human) inhalation powder, for oral inhalation use, make false or misleading claims and/or representations about the risks associated with Afrezza by suggesting that there are no safety concerns associated with using the drug. A 10/5 [Warning Letter](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM623557.pdf?ref=fdaweb.com) says the violations are particularly concerning from a public health perspective because Afrezza has multiple serious, life-threatening risks, including a Boxed Warning for the risk of acute bronchospasm in patients with chronic lung disease.

The Afrezza labeling says it is a rapid acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus. It is to be used in combination with a long-acting insulin in patients with Type 1 diabetes. The labeling describes a number of serious risks associated with the drug, OPDP says.

The letter says the Facebook post suggests that there are no risks associated with using Afrezza, claiming it will “help your body work its best and protect you from health complications.” OPDP says this may not be the case since the drug is associated with multiple serious and potentially life-threatening risks such as those in the Boxed Warning.

“By suggesting that there are no risks associated with use of Afrezza,” OPDP says, “this post is misleading with respect to the drug’s safety.” The letter acknowledges the post has a link to the full prescribing information, but says that does not mitigate the misleading impression from the claims in the post.

OPDP tells MannKind to stop misbranding Afrezza through its promotional materials and/or stop introducing the misbranded drug into interstate commerce. The company was told to submit a plan for discontinuing use of violative promotional materials and a comprehensive plan for disseminating truthful, non-misleading, and complete corrective messages about the issues discussed in the letter to audiences that received the violative materials.