AstraZeneca Hit for Misleading Breztri Ads

The FDA’s Office of Prescription Drug Promotion (OPDP) has reprimanded AstraZeneca for making false and misleading claims about its chronic lung inflammatory inhalation therapy Breztri Aerosphere (budesonide, glycopyrrolate and formoterol fumarate).

In a warning letter dated Aug. 4, OPDP said AstraZeneca made claims “in the context of a promotional communication” describing the safety and efficacy of Breztri in misleading terms because they suggest the treatment “has been shown to have a positive impact on all-cause mortality” and reduce the risk of death in patients suffering from chronic obstructive pulmonary diseases.

The FDA requested that AstraZeneca devise a comprehensive plan of action to “disseminate truthful, non-misleading and complete” corrective communication about the concerns discussed. This corrective communication should be sent to the audience that received the original ads, advised the warning letter.

Read the AstraZeneca warning letter here.

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