In 2013, a year after the Food and Drug Administration (FDA) approved the diet pill Belviq for use in the United States, the European Medicines Agency (EMA) deemed it too dangerous to be sold in Europe. Laboratory studies that showed Belviq could cause cancerous tumors in mice. Since the drug was intended to be a long-term treatment, could it have the same effect on humans?
The disparity between what the FDA and EMA on the approval of the Belviq prompted Dr. Sidney Wolfe, a leading consumer health advocate, to opine in the journal BMJ, “Are Americans more resistant to the risks and more likely to benefit from certain drugs than Europeans or, on the contrary, is the European Medicines Agency more resistant than the U.S. Food and Drug Administration to the drug industry’s desire to get approval for drugs with unique risks but without compensating benefits?”
Wolfe’s commentary made it clear he felt the EMA had made the right choice. His concern was not just the health risks. The diet pill was designed to make users less interested in food. Over the course of pre-approval clinical trials, Belviq users lost 3 to 3.7% of their weight, nearly three times less than Qsymia, another diet pill approved by the FDA at the same time. Furthermore, participants who stopped taking Belviq gained back a quarter of the weight they had lost while on the drug by the end of the second year. In other words, Wolfe pointed out, the benefits of Belviq were hardly enough to justify the risks. Yet, the FDA approved the diet pill and exposed thousands of consumers to cancer, he said.
Seven years after Wolfe’s BMJ commentary, on Feb. 13, 2020, the FDA called for the withdrawal of Belviq from the U.S. market citing long-term clinical trials that showed users of the pill had a greater occurrence of cancer than nonusers. According to the FDA, one additional case of cancer was observed per 470 patients taking Belviq for one year. The cancers most linked to people who used the diet pill were pancreatic cancer, colorectal cancer, and lung cancer.
The drug’s manufacturer, Eisai, reluctantly pulled the pill off the market. The FDA didn’t recommend that users undergo any special cancer screenings. However, Belviq users with previous cancer diagnoses may want to talk with their doctors about the risk of recurrence.
If you used Belviq and then were diagnosed with cancer, you should talk to an attorney. You may have a case against the manufacturer. Attorneys with Beasley Allen Law firm are currently investigating cases of pancreatic cancer, colorectal cancer, and lung cancer in patients who have been treated with Belviq. Please contact Roger Smith, Ryan Duplechin or Melissa Prickett to discuss a possible claim, or fill out our contact form on this website for a free consultation.