[Updated February 2020] The FDA is examining at the link between Belviq and cancer. On February 13, 2020, the U.S. Food and Drug Administration (FDA) asked Eisai, to voluntarily withdraw Belviq, its popular weight loss drug, from the U.S. market. The request comes on the heels of concerns between certain types of cancers linked to taking the drug. The request follows a January 2019 alert from the FDA.
Eisai has agreed to the withdrawal.
According to the FDA, “Patients should stop taking lorcaserin and talk to your health professionals about alternative weight-loss medicines and weight management programs.” The agency also recommends disposing of the medications although we urge anyone who might be contemplating a lawsuit or claim for damages to hold on to the prescription empty bottle after safely disposing of the medication.
Last month on January 14, 2020 the FDA released this Drug Safety Communication:
“The FDA is alerting the public that results from a clinical trial assessing safety show a possible increased risk of cancer with the weight management medicine Belviq, Belviq XR (lorcaserin). At this time, the cause of the cancer is uncertain, and we cannot conclude that lorcaserin contributes to the cancer risk. However, we wanted to make the public aware of this potential risk. We are continuing to evaluate the clinical trial results and will communicate our final conclusions and recommendations when we have completed our review.”
The cancers of most concern to the FDA include pancreatic cancer, lung cancer and colorectal (colon cancer). While the warning is somewhat muted, given the history of Belviq and possible links to cancer everyone should be very concerned.
Belviq is the brand name of a drug called lorcaserin. Available only by prescription, lorcaserin was first approved by FDA in 2012 to help weight loss in adults who are obese or are overweight and have weight-related medical problems. Lorcaserin works by increasing feelings of fullness so that less food is eaten. It is available as a tablet (Belviq) and in extended-release form (Belviq XR).
Lorcaserin was a big deal in the weight loss world when released in 2012. It was the first new weight loss drug since the recall of Fen Phen in 1997.
Lorcaserin’s release was anything but smooth sailing. Consumer advocates has been warning of a link between Belviq and cancer for several years before it was ultimately cleared for release. The drug’s release was initially rejected in 2010 because of those concerns.
Rodent testing had suggested a higher rate of brain and breast 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.
Arena Pharmaceuticals, owner of the drug, claimed there was no correlation between the cancers found in rats and that in humans. They also indicated that the dose given to the rats was much stronger than that taken by humans.
Arena assured the FDA that the tumors developed by the rats were rodent specific and not likely to affect humans. Shortly after those assurances, the drug was approved for sale on the American market. The FDA’s vote was 18 to 4 in favor of approval.
Why did the FDA suddenly change its mind? Apparently because of new long term studies.
“When approving [Belviq], we required the drug manufacturer, Eisai Inc., to conduct a randomized, double-blind, placebo-controlled clinical trial to evaluate the risk of heart-related problems. In this trial, which was conducted in approximately 12,000 participants over 5 years, more patients taking [Belviq] were diagnosed with cancer compared to patients taking placebo, which is an inactive treatment. Our evaluation of this potential signal is ongoing, and at this time it is uncertain if [Belviq] increases the risk of cancer.”
Now the FDA is saying that the risks of cancer outweigh the benefits of the drug. Specifically, the FDA says studies show a slightly higher cancer risk for Belviq users and a higher risk for specific cancers – colon, pancreas and lung.
If there is any silver lining, it is that Belviq was not widely embraced by obesity doctors. Even the FDA had previously questioned the benefits of lorcaserin when taken by obese patients that were not suffering from Type 2 diabetes.
Mahany Law Investigation into Lorcaserin (Belviq)
We are currently looking to speak with patients who were diagnosed with cancer while taking lorcaserin. At this time are accepting new clients although no lawsuits have yet been filed. Working with medical experts and other lawyers we hope to determine the extent of the link and how much the company knew about the risks of cancer and when. We are only signing up patients who tool lorcaserin and later develop pancreatic cancer, lung cancer or colon cancer. We are maintaining a list of those who developed breast cancer, brain cancer and other forms of cancer. Please contact us online or by email at .
Mahany Law Seeking Arena Pharmaceuticals and Eisai Co. Whistleblowers
We are unique among products liability law firms. We got our start by representing whistleblowers – dedicated men and women working within the pharmaceutical industry who grow tired of the greed and corruption. Compliance professionals, independent testing labs, medical directors and folks working in research and development are our eyes and ears.
When drugs are on the Medicare formulary, we can often obtain cash rewards for information about cGMP violations involving the manufacture of a particular drug. Ditto for patient safety information deliberately withheld from the FDA. Unfortunately, lorcaserin is not covered by Medicare. That means there are no rewards available from the government.
Notwithstanding that we cannot pay for information, we are always interested in speaking with concerned pharmaceutical industry professionals who have information. Even if you speak with us anonymously, our goal is to ensure that the FDA is aware of all adverse reports and that the public is protected. If you know something, say something. Please contact us directly (202-800-9791 or ) or the FDA. [If you are calling about a drug on the Medicare formulary – most prescription drugs are – you may be eligible for an award of up 30% of whatever the government collects from the wrongdoers.]
[Important patient disclosures. We are presently conducting an investigation and have not determined whether there are actionable claims against Arena Pharmaceuticals and others involved in the distribution of Belviq. We do not share patient information with anyone outside our firm and network. We are a law firm and not a lead generation company. Providing your information helps investigate whether there are viable claims against Arena Pharmaceuticals. By providing that information we are not becoming your lawyer nor are we agreeing to file a lawsuit on your behalf although any information you provide is protected by the attorney – client privilege and kept confidential
Any subsequent agreement to provide legal services must be in writing. Cancer patients taking lorcaserin that provide us information to assist in our investigation are not precluded from contacting or hiring other lawyers. Only if we enter into a representation agreement do we become your lawyers. The time to file a lawsuit varies greatly by state. We thank you personally and on behalf of other cancer patients for your assistance.]
Ready for some fun? Here is a 2019 video in which a talking head doctor tells us just how safe Belviq is! What Dr. Charles Vega doesn’t disclose is that in 2018 he accepted over $16,000 from drug companies, mostly for promotional speaking opportunities and related events and travel. (See ProPublica’s Dollars for Docs for more details.)