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According to allegations raised in a product liability lawsuit filed after a New Jersey man developed pancreatic cancer from Belviq, manufacturers of the recalled weight-loss drug knew or should have known that users faces significant risks of cancer, yet continued to market and sell the medication for years.
The complaint (PDF) was filed by Cornelius Byrne in Superior Court of New Jersey for Bergen County on May 10, presenting claims against Eisai, Inc. and Arena Pharmaceuticals, as defendants.
Belviq (lorcaserin) was introduced in 2012, as the first new diet pill approved in the United States after a series of recalls and problems associated with other weight-loss medications introduced in prior decades. However, in February 2020, the FDA required a Belviq recall, after identifying an increased incidence of cancer among users of the medication in post-marketing study data.
According to the lawsuit, Byrne was prescribed Belviq in April 2015 for weight loss and diet control, and he continued to take the drug until January 2019, believing it was safe and effective. In July 2020, Byrne was diagnosed with pancreatic cancer, which he indicates was either caused or significantly contributed by his of Belviq, leaving him with permanent injuries, and the need for constant medical monitoring.
“Upon information and belief, despite cancer findings in animal carcinogenicity studies, Eisai and Arena failed to adequately conduct complete and proper testing of Belviq prior to filing their New Drug Application for Belviq,” according to the complaint. “[F]rom the date Defendants Eisai and Arena received FDA approval to market Belviq, [the drug makers] devised a plan to manufacture, distribute, market and sell Belviq without adequate warnings to prescribing physicians or Plaintiff that Belviq was associated with and/or could cause cancer.”
After an FDA advisory panel decided to approve the medication in April 2012, the consumer watchdog group Public Citizen warned there would be problems with Belviq, predicting the diet drug would eventually be removed from the market like a number of other previously-approved weight-loss treatments.
In July 2019, an expert analysis of the CAMEILLIA-TIMI 61 Trial was published by the American College of Cardiology. The study looked at the effectiveness and side effects of Belviq, including the largest concern at the time: cardiovascular risks.
While not publicly announced until months later, the data contained concerning indications about a potential link between Belviq and pancreatic cancer, colorectal cancer and lung cancer. However, the FDA did not issue Belviq cancer warnings until January 2020, and several weeks later it was determined the weight loss drug needed to be removed from the market.
Even before then, at the time the medication was first approved, the FDA required the drug makers to conduct a five year follow up study involving about 12,000 participants to evaluate the potential heart risks associated with the medication. However, researchers identified at least 462 individuals treated with Belviq who were diagnosed with 520 different primary cancers over a median follow up time of three years and three months.
“Plaintiff’s use of Belviq caused or significantly contributed to his development of pancreatic cancer, which has permanently changed his life,” according to the lawsuit filed by Byrne. “By reason of the foregoing, Plaintiff had to undergo significant treatment and now requires constant and continuous medical monitoring and treatment due to the defective nature of Belviq.”
The case joins a number of Belviq cancer lawsuits filed over the last year by former users who allege that cancer diagnosed in recent years was a result of the medication.
In addition to individual cancer diagnosis lawsuits over Belviq, a number of class action claims have also been filed on behalf of former users who paid about $300 per month for the diet drug, and now face continuing health risks that require medical monitoring.
Since the strongest sales for Belviq have come over the past few years, it is widely expected that additional lawsuits will be filed in the coming months and years, as former users may be diagnosed with cases of breast cancer, pancreatic cancer, colorectal cancer, lung cancer and other injuries.