Belviq Recall

FDA reviewed safety data from the Cardiovascular and Metabolic Effects of Lorcaserin in Overweight and Obese Patients – Thrombolysis in Myocardial Infarction 61 (CAMELLIA-TIMI 61) clinical trial. The trial looked at the risk of major cardiovascular events in people who took lorcaserin.

The trial was conducted between January 2014 and June 2018 and consisted of 12,000 men and women who were overweight or obese, according to the FDA’s February 2020 Drug Safety Communication. While researchers were looking into cardiovascular safety, they also noted more diagnoses of cancer among people who took Belviq versus those who took placebo.

“There was a numerical imbalance in the number of patients with malignancies, with one additional cancer observed per 470 patients treated for one year … Imbalances in specific cancers including pancreatic, colorectal, and lung contributed to the observed overall imbalance in cancer cases. There was no apparent difference in the incidence of cancer over the initial months of treatment, but the imbalance increased with longer duration on lorcaserin,” the agency said.

This means the FDA determined the potential cancer risk increases the longer people take Belviq — especially the risk of pancreatic, colorectal and lung cancers.

Eisai Inc. announced that it was withdrawing Belviq from the U.S. market on Feb. 13, 2020, after the FDA requested the withdrawal. A market withdrawal is different from a recall.

FDA defines a market withdrawal as a “firm’s removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by the FDA or which involves no violation.”

In contrast, recalls are a “firm’s removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action.”

The FDA released its first safety communication about Belviq’s potential cancer link on January 14, 2020. In this communication, the agency alerted the public to a possible increased risk of cancer with Belviq and Belviq XR but did not have enough data to recommend withdrawal.

After more review, it requested the withdrawal in February.

While the FDA did not classify Belviq as dangerous, it recommended that patients stop taking Belviq immediately and to ask their health care provider for alternatives.

The agency also told prescribers to contact patients currently taking lorcaserin and to tell them to stop taking the medication. Prescribers should also stop dispensing and prescribing the drug.

With regard to the risk of cancer, the FDA did not recommend special screening for patients who have taken lorcaserin. Patients should talk to their doctor if they have questions.

The drug’s maker, Eisai Inc., did not agree that the risk of cancer found by the FDA outweighed the benefits of the drug for weight loss.

“Eisai’s interpretation of the data from the CAMELLIA-TIMI 61 trial differs from that of the FDA. The Company’s assessment is that BELVIQ and BELVIQ XR continue to have a positive benefit-risk profile in the patient population for which they are indicated,” the company said in its Feb. 13, 2020, statement.

Aside from the potential risk of cancer, Belviq’s most common side effects include headache, dizziness, back pain and fatigue. It’s also a controlled substance and classified as a Schedule IV drug by the U.S. Drug Enforcement Administration and may have the potential for abuse.

The FDA recommends that patients look for alternatives to lorcaserin. Fortunately, there are several FDA-approved medication alternatives for adults still on the U.S. market.

One 2022 research report noted that preliminary uncontrolled studies of lorcaserin in patients with Dravet syndrome, a rare form of epilepsy, have yielded promising results.