Belviq Weight-loss Drug Cancer Lawsuit
The U.S. Food and Drug Administration has asked drug manufacturer Eisai to recall their diet drug Belviq and long-acting Belviq XR (lorcaserin) after results of a 5-year safety study showed an increased risk of cancer in people who take the medication.
The increased risk involved multiple types of cancer including:
- Pancreatic cancer
- Colorectal cancer
- Lung cancer
The FDA advised that users of Belviq stop taking the medication and discuss alternative weight-loss medications or methods with their health care providers. The FDA is not currently recommending that additional testing is needed but has stated that the risks of continuing to take the medication outweigh the benefits.
Patients who took Belviq or Belviq XR and were later diagnosed with cancer may be eligible for compensation for their injuries.
Belviq Weight Management Treatment
Belviq (lorcaserin) is a medication used for chronic weight management. It works as a weight-loss drug by stimulating serotonin 2C receptor to produce a feeling of fullness and reduce appetite.
The FDA approved Belviq in 2012 to be used as part of a weight management program which included a reduced calorie diet and increased physical activity in adult patients with an initial body mass index (BMI) of:
- 30 kg/m² or greater (considered to be obese)
- 27 kg/m² or greater (considered to be overweight) when the patient also has other weight-related conditions such as high blood pressure, high cholesterol or type 2 diabetes
A normal BMI is considered to be 18.5 to 24.9 kg/ m².
Belviq Cancer Risk
After approval, Eisai conducted an FDA-required study to examine the long-term safety risk of Belviq toward cardiovascular health and other chronic concerns. Results of the five-year study, involving 12,000 patients, showed no increase in cardiovascular events but did show a slight increase in a range of cancers.
Increased cancer risk of Belviq included:
- Pancreatic cancer
- Colorectal cancer
- Lung cancer
Patients taking Belviq were diagnosed with cancer at a rate of 7.7%, compared to those taking placebo whose cancer rate was 7.1%. The increased risk was seen only in patients who had taken Belviq for an extended period of time, and the cancer rate increased the longer medication was taken.
FDA Issues Belviq Safety Warning
The FDA issued a safety communication in January of 2020 which stated that Belviq and Belviq XR had been linked to cancer. The Agency did not conclude that the increase in cancer rate was directly related to the medication but recommended that health care professionals evaluate the risks of Belviq in comparison to potential benefits when prescribing the medication.
On February 13, 2020, the FDA announced that Belviq’s manufacturer, Japanese pharmaceutical manufacturer Eisai, had agreed to withdraw or recall the medication from the U.S. market. Eisai released a statement denying the link between Belviq and cancer, but indicated their compliance with the voluntary withdrawal.
The FDA recommended that patients stop taking Belviq and discuss alternative medications or weight-loss methods with their health care providers. They did not recommend that additional cancer screening was required at this time.
Side Effects of Belviq
All medications cause side effects, most of which are mild-to-moderate and will go away with time. Some Belviq side effects, however, may be more serious or even life-threatening.
Serious side effects
In addition to cancer risk of Belviq, other side effects may be severe or serious including:
- Serotonin syndrome – Serotonin syndrome may occur due to excessive levels of serotonin in certain areas of the brain and is more likely when certain medications are taken such as antidepressants and other medications affecting serotonin. Symptoms may include changes in mental status, blood pressure, heart rate or rhythm, high temperature, and movement disorders. In severe cases, serotonin syndrome may be serious or even life-threatening.
- Cognitive impairment – Some patients have experienced memory loss, attention impairments, confusion, and sleepiness. Patients are cautioned about operating hazardous equipment or driving until they know how the medication will affect them.
- Psychiatric disorders – Symptoms of hallucinations, euphoria and dissociation were experienced by some taking Belviq. Prescribing information also recommends monitoring patients for suicidal thoughts and behaviors or worsening of depression and that medication should be discontinued if severe mood changes occur.
Common side effects
Common side effects of Belviq which are mild-to-moderate and often go away with time include:
- Nausea
- Diarrhea
- Headache
- Dizziness
- Fatigue
- Dry mouth
- Constipation
Belviq Lawsuit Settlements
The FDA announced in February 2020 that Japanese drug maker Eisai Inc. agreed to withdraw diet drug Belviq and Belviq XR after the medication was linked to an increased risk of cancer including colorectal cancer, pancreatic cancer, and lung cancer.
The first U.S. Belviq Cancer Lawsuit was filed in September 2020 in Missouri and though multiple lawsuits followed in federal, state, and local courts, they have not been consolidated into multidistrict litigation (MDL) and are being addressed separately. While some cases have settled for confidential amounts, many others are still being litigated in courts across the U.S. Eisai and Arena drug companies may be facing similar concerns in other countries besides the U.S.
Some Belviq lawsuit settlements have been offered; however, terms have not been disclosed and negotiations for a global lawsuit settlement may be ongoing.
*Prior results do not guarantee or predict a similar outcome with respect to any future matter.