FDA Policy/General

‘False or Misleading Claims, Representations’ in Gvoke Ad

The CDER Office of Prescription Drug Promotion (OPDP) says a TV ad for Xeris Pharmaceuticals’ Gvoke (glucagon) injection for subcutaneous use makes false or misleading claims and representations about the risks associated with and efficacy of Gvoke. An 8/14 Notice of Violation says the violations are concerning from a public health perspective because they create a misleading impression about the safety and effectiveness of Gvoke, a drug used to treat severe hypoglycemia that is associated with several serious and life-threatening risks, according to the notice.

OPDP says Gvoke is contraindicated in patients with pheochromocytoma, insulinoma, and in patients with a known hypersensitivity to glucagon or any of the excipients in Gvoke. The labeling also contains Warnings and Precautions regarding catecholamine release in patients with pheochromocytoma, hypoglycemia in patients with insulinoma, hypersensitivity and allergic reactions, lack of efficacy in patients with decreased hepatic glycogen, necrolytic migratory erythema, and hypoglycemia in patients with glucagonoma.

The letter says the TV ad is misleading because it makes Gvoke efficacy claims but fails to include important risk information associated with the drug. It also says the ad misleadingly suggests that the Gvoke pre-filled syringe can be easily used and individuals can confidently recognize that they have correctly administered the product. It notes that the labeling Dosage and Administration section and the Instructions for Use describe multiple steps involved in the preparation and administration of the Gvoke pre-filled syringe and recommends that users become familiar with the instructions before an emergency happens.

OPDP asks Xeris to immediately cease the violations and respond with a list of all Gvoke promotional materials that contain violations such as those described in the letter and the company’s plan for discontinuing their use.

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