Lorcaserin Withdrawal and Obesity Care Week

| March 1, 2020

by Dr. Christopher D. Still, DO, FACN, FACP
Co-clinical Editor of Bariatric Times; Medical Director for the Center for Nutrition and Weight Management, and Director for Geisinger Obesity Research Institute at Geisinger Medical Center in Danville, Pennsylvania.

Dear Colleagues:

My original plan for this month’s editorial message was to discuss “March Madness” over the keto diet and intermittent fasting and try to make some sense of their current craze. Instead, I recently learned that the United States (US) Food and Drug Administration (FDA) requested the withdrawal of lorcaserin (Belviq®) from the US market due to a small increase in observed cancers in a large cardiovascular safety study. This study enrolled ~12,000 men and women over five years with established cardiovascular disease (CVD) or at high risk for CVD. The study was conducted at over 400 sites in eight countries. It was the largest cardiovascular outcome trial (CVOT) conducted to date for a weight loss medication. For full disclosure, I/we participated as one of the US sites. Eisai, the manufacturer of lorcaserin, complied with the request of the voluntary withdrawal.

Following its review of the data, the FDA concluded that the potential risk of lorcaserin outweighs the benefit. More specifically, according to Eisai’s press release,1 the FDA noted there was a numeral imbalance in the number of patients with malignancies. The FDA’s analysis of the study found that during the trial, 462 (7.7 %) patients treated with lorcaserin were diagnosed with cancers compared to the placebo group, in which 423 (7.1%) patients were diagnosed with cancers. Eisai went on to say that their interpretation of the data differs from that of the FDA but complied with the voluntary withdrawal.

Was this the correct decision to withdrawal based on the perceived difference of 0.6 percent? I am not saying it was or it wasn’t, and obviously patient safety is of the upmost importance, but one also has to look at the risk–benefit assessment. The study found no increase in cardiovascular risk and found a reduction in the risk of developing diabetes. Was this the FDA’s “knee-jerk” reaction concerned that it would be another “Phen-Fen” situation and a rush to judgment? Will this set the field of obesity treatment back after all the great strides forward it has made over the last decade? I hope not, but only time will tell.

Now, on to Obesity Care Week (OCW) 2020. I am sure I don’t have to remind you that March 1 to 7 is OCW. OCW is an annual public awareness effort supported by more than 50 countries worldwide and more than 55 healthcare-focused organizations. From advocating for fair treatment of obesity to ending weight bias, OCW aims to raise awareness, educate, and advocate for a better world for people living with obesity. Each day of this awareness week is dedicated to highlight issues impacting people with obesity:

  • March 1: Launch Day
  • March 2: Weight Bias Day
  • March 3: Obesity Treatment Day
  • March 4: World Obesity Day
  • March 5: Access to Care Day
  • March 6: Childhood Obesity Day
  • March 7: “I Care” Day

I hope we all celebrate how far we have come in helping our patients struggling with the disease of obesity. And for all you March Madness basketball fans, GO PENN STATE!

References

  1. Eisai to Voluntarily Withdraw BELVIQ®/BELVIQ XR® in the U.S. https://www.prnewswire.com/news-releases/eisai-to-voluntarily-withdraw-belviqbelviq-xr-in-the-us-301004885.html. Accessed February 20, 2020.

Sincerely,

Christopher D. Still, DO, FACN, FACP

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