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FDA Warns Drugmaker for Diabetes Drug TV Ad
Drugs Inspections and Audits
The FDA has rapped Chicago, Ill.-based drugmaker Xeris Pharmaceuticals for a misleading television ad for its diabetes drug Gvoke (glucagon injection).
The agency said the advertisement misled patients because it lacked important risk information from the product’s labeling and failed to mention the drug’s contraindication in patients with a known hypersensitivity to glucagon or to the drug’s excipients.
In an untitled letter — which the agency uses for violations that don’t meet the regulatory threshold for a full warning letter — the agency noted that the ad lacked a warning about hypersensitivity and allergic reactions, such as anaphylactic shock.