FDA Warns Teva about Misleading Clozapine Claims

In April 2013, the U.S. Food and Drug Administration (FDA) sent a warning letter to Teva Neuroscience, the manufacturer of Clozapine. Clozapine is an antipsychotic drug used to treat schizophrenia and other mental conditions. The letter warned the director of Teva that the company violated the Federal Food, Drug, and Cosmetic Act by misbranding Clozapine and misleading consumers.

In the warning letter, the FDA states that Teva “makes unsubstantiated superiority and other claims regarding clozapine, omits material facts, and minimizes the risks associated with the drug.” The FDA requested that Teva immediately terminate the Clozapine promotional materials that violated regulations. Additionally, Teva was asked to write a response letter indicating whether or not it intends to comply. In the response, Teva is required to list all promotional materials that contain violations and explain the company’s plan to discontinue the use of those materials.

Clozapine Unsubstantiated Claims

The FDA notes that Teva makes unsubstantiated claims about the benefits of using Clozapine. In the promotional materials in question, Teva claims that Clozapine is superior to similar drugs such as olanzapine, haloperidol, and risperidone. Teva asserts that Clozapine showed superiority in the excitement symptom cluster. This cluster effects the patient’s excitement, hostility, poor impulse control, and uncooperativeness.

In response to these claims, the FDA states that there is no substantial evidence or clinical experience to support such claims. Claims such as these require a head-to-head clinical trial in order to substantiate. However, Teva did not conduct this type of clinical trial. Teva used retrospective data to make this claim. The FDA finds this to be insufficient.

Minimization of Clozapine Risk

The FDA also noted that Teva did not include a fair balance for both the benefits and risks associated with the use of Clozapine. The Clozapine promotional materials used colorful and eye-catching graphics and photos to draw attention to the information that the company wanted to emphasize. These areas also included sufficient amounts of white space to ensure that the points made were accented and easy-to-read.

However, the information discussing Clozapine risks was not as aesthetic. This section appeared crammed with no headers used to distinguish between sections. Additionally, the risk information was in black and white, as well as generally more difficult to read than other sections. The FDA wrote, “The overall effect of this presentation undermines the communication of important risk information, minimizes the risks associated with clozapine, and misleadingly suggests that clozapine is safer than has been demonstrated,”

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.