FDA Policy/General

False, Misleading Claims in Xatmep Professional E-Mail: OPDP

The CDER Office of Prescription Drug Promotion (OPDP) says a healthcare professional e-mail for Azurity Pharmaceuticals’ Xatmep makes false or misleading claims and/or representations about the drug’s risks and efficacy. An 11/24 Notice of Violation says the violations are especially concerning from a public health perspective because they create a misleading impression about Xatmep’s safety and effectiveness.

The Xatmep labeling says it is indicated for treating pediatric patients with acute lymphoblastic leukemia as part of a multi-phase, combination chemotherapy maintenance regimen. The labeling includes a Boxed Warning that describes severe toxic reactions, including embryo-fatal toxicity.

The letter says Azurity “appears to be promoting Xatemp without presenting the serious risks of the drug in a truthful and non-misleading manner, despite concerns previously expressed by OPDP.”

OPDP says the Azurity professional e-mail presents numerous benefit claims for Xatmep with the Boxed Warning but without other important Warnings and Precautions associated with the drug.

While benefit claims for Xatmep are prominently presented in the body of the e-mail in a bulleted list, the letter says, the limited risk information is presented after the signature block, thus failing to present the limited risk information with a prominence and readability reasonably comparable to the presentation of information relating to the drug’s benefits.

Azurity was told to immediately cease any violations of the Federal Food, Drug, and Cosmetic Act and to respond with a list of Xatmep promotional materials that contain representations described in the letter and a plan for discontinuing their use.

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