Why Did It Take the FDA 8 Years to Recall Belviq?
We first wrote about Belviq in January 2020, weeks before the FDA asked Belviq’s US distributor, Eisai, to voluntarily recall the drug. In announcing the recall on February 13th, the FDA said,
“FDA has requested that the manufacturer of Belviq, Belviq XR (lorcaserin) voluntarily withdraw the weight-loss drug from the U.S. market because a safety clinical trial shows an increased occurrence of cancer. The drug manufacturer, Eisai Inc,. has submitted a request to voluntarily withdraw the drug.
“When FDA approved lorcaserin in 2012, we required the drug manufacturer to conduct a clinical trial to evaluate the risk of cardiovascular problems. A range of cancer types was reported, with several different types of cancers occurring more frequently in the lorcaserin group, including pancreatic, colorectal, and lung.”
Belviq is the brand name for lorcaserin.
If the FDA approved the drug in 2012, why did it take years before the FDA decided to ask the drug be pulled from shelves?
Great question! The better question might be why the FDA approved the drug in the first place? We will answer both questions below.
Lorcaserin’s Checkered History
When released in 2012, Lorcaserin was the first weight loss drug approved since Fen Phen 15 years earlier. Finally, people suffering obesity had a new drug that might help them.
Whether the drug was any help is questionable. A clinical study by the University of Pennsylvania revealed that lorcaserin and lifestyle changes resulted in an average 20.7 pound loss. Sounds great, BUT… Participants who took a placebo and made lifestyle changes lost an average of 16.5 lbs.
The difference was only 4 lbs! And Belviq cost about $300 per month. It sounds like lifestyle changes are the better way of losing weight.
Whether or not Belviq actually helped people lose weight, a bigger safety issue was looming. The first time lorcaserin came up for approval by the FDA it was denied because of cancer fears. Europe also refused to approve the drug.
Part of the testing at the time involved lab testing on rats. The results of those studies showed a higher rate of brain and breast cancer. Is losing four or five pounds worth the risk of brain cancer?
According to the FDA, “The non-clinical issues identified by the FDA included diagnostic uncertainty in the classification of mammary masses in female rats, unresolved exposure-response relationship for lorcaserin-emergent mammary adenocarcinoma, and unidentified mode of action and unclear safety margin for lorcaserin-emergent brain astrocytoma.”
Astrocytoma is a form of brain and spinal cord cancer.
The company making the application then was Arena Pharmaceuticals. They went back to the FDA and said there was no correlation between the cancers found in rats and that in humans. (So why test on rats?)
Arena also said the dose given to the rats was much stronger than that taken by humans.
Reluctantly in a split vote the FDA approved the drug. The Europeans didn’t budge. The FDA vote was 18 to 4 in favor of approval.
As part of the approval, the FDA required a much larger, long term clinical trial on humans. Short term trials typically don’t catch cancer because cancer can take years to develop.
This past winter those test results came back. People taking Belviq have a higher risk of cancer than those that don’t. The particular cancers that proved worrisome to the FDA include pancreatic, colorectal, and lung cancer. All are often fatal.
Now eight years later the FDA is saying that the risks of cancer outweigh the benefits of the drug.
Eisai, the company that markets Belviq in the U.S. says its product is safe. The company released a statement saying, “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.”
Should I Stop Taking Belviq?
As lawyers, we cannot provide medical advice. Our best advice is to always speak to your doctor before discontinuing a medication. In this case, the FDA says, “Patients should stop taking lorcaserin and talk to your health professionals about alternative weight-loss medicines and weight management programs.”
Although the FDA also recommends that you safely dispose of any remaining medications, we suggest that you keep the bottle in case it is needed for a future lawsuit.
Were You Taking Belviq and Diagnosed with Cancer?
The defective drug lawyers at Mahany Law are presently investigating Belviq and its makers. For more information, visit our Belviq lawsuit claims page or watch our Belviq lawsuit video. If you have been diagnosed with cancer, don’t delay in contacting a lawyer. Many states have short time limits in which to file a lawsuit.
Ready to see if you have a case? Contact us online, by email brian@mahanylaw.com or by phone 202-800-9791. Cases accepted anywhere in the United States. We accept cases on a contingency fee basis meaning no legal fees or costs unless we recover money on your behalf. Any information you provide is protected by the attorney – client privilege and kept confidential.
Every case is different and simply because you have been diagnosed with cancer doesn’t mean that it is connected to Belviq.
Unlike the late night TV commercials, we are a law firm and not a lead generation company. By contacting us doesn’t mean we have become your lawyer. We investigate each case separately. At this time, we are only considering cases involving lung, pancreatic or colorectal cancer. Unfortunately, we cannot consider cancer that started elsewhere in the body and spread to the lungs, pancreas or colon.
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