The U.S. Food and Drug Administration (FDA) has sent a warning letter to Currax Pharmaceuticals LLC, citing violations of the Federal Food, Drug, and Cosmetic Act.

A sponsored Google link for the company’s weight-loss drug Contrave “makes false or misleading claims about the risks” of taking the drug and its effectiveness, states the recent letter from the FDA’s Office of Prescription Drug Promotion (OPDP).

Currax, based in Morristown, N.J., acquired Nalpropion Pharmaceuticals, Inc., in 2019, giving Currax the rights to Contrave, an FDA-approved, prescription-only pill. A Currax press release said Contrave is the most prescribed weight-loss brand medication in the United States.

Contrave’s patient information leaflet includes a boxed warning describing “the risk of suicidal thoughts and behaviors,” but the OPDP wrote that the Google link did not include the risk warning or information on Contrave’s limitations of use.

Contrave’s safety in combination with other products intended for weight loss and its effect on heart health have not been established, according to the OPDP. The letter warned Currax that the link “creates a misleading impression about the FDA-approved indications for Contrave.”

The OPDP also said that the link should have provided the following information: The drug should only be prescribed for patients with a body mass index (BMI) of 30 kg/m2 or greater if they have no other weight-related conditions, or a BMI of 27 kg/m2 or greater if they have at least one condition related to weight, such as type 2 diabetes or high blood pressure.

The letter also warned Currax that the statement “Lose 2-4x more weight on average than with diet and exercise alone!” is not enough to let the consumer know that Contrave must be used with diet and exercise in order to achieve weight loss. These claims “imply that patients, no matter their BMI” will lose weight, “when it is not approved for use in patients that do not meet the initial BMI criteria,” the letter said. The OPDP also stated that the sponsored link misrepresented the “average” weight loss a patient might achieve with Contrave and failed to include results of clinical studies.

A 2019 press release said the combined values and performances of the Nalpropion acquisition and Currax should bring in $10 million annually.

The take-home

If you are taking or considering taking Contrave, talk with your doctor about Contrave’s risks, benefits and contraindications. Do not stop taking any medicine without talking with your doctor first. Abruptly stopping a medicine could be dangerous.