After a request from the U.S. Food and Drug Administration (FDA Japanese pharmaceutical manufacturer, Eisai, agreed to voluntarily recall its weight-loss drug Belviq (lorcaserin).
The request was made based on results of a long-term safety study links long-term use of Belviq or Belviq XR to an increased risk of cancers including:
- Pancreatic cancer
- Lung cancer
- Colorectal cancer
In their February 13, 2020 safety announcement, the FDA indicated that risks of the medication outweigh any potential benefits. Patients taking Belviq were advised to discontinue taking the drug and to talk to their health care provider about other diet medications or weight loss methods. No additional testing was said to be required at this time regarding the cancer risk.
Eisai Inc. may be facing Belviq lawsuits filed by people who took Belviq or Belviq XR for an extended period and were diagnosed with cancer.
Belviq Recalled over Cancer Risk
As the first diet drug approved after the Fen-Phen controversy which caused cardiac side effects in hundreds of users, in 2012, the FDA required that Eisai begin a long-term study on the use of Belviq and potential cardiovascular effects along with other safety issues.
In January of 2020, the FDA issued a safety alert based on the results of that five-year study which examined 12,000 patients. The study concluded no definitive cardiac effects, however an increase in a variety of cancers was noted for patients who took the medication for an extended period of time. Longer term use correlated to increased risk. The January warning advised health care providers to carefully evaluate the potential benefits of Belviq and the increased risk of cancer.
Though the Agency stopped short of declaring that the cancer increase was directly caused by use of Belviq, the FDA requested that Japanese manufacturer, Eisai recall both Belviq and Belviq XR from the U.S. market. The company has agreed to comply and has voluntarily withdrawn the drug, though a statement released by Eisai denied a link had been established.
On February 13, 2020, the FDA issued a new safety notification stating that the medication was being withdrawn or recalled and advising patients to discontinue taking Belviq. The Agency recommended that Belviq users contact their health care providers to discuss alternative medications or weight-loss procedures but did not state that additional cancer or other medical screening would be required at this time.
Belviq Use and Side Effects
Belviq (lorcaserin) is a medication used for weight management in obese and overweight individuals who have medical conditions related to weight. It is approved to be used in people with a body mass index (BMI) significantly above the stated normal level of 18.5 to 24.9 kg/ m².
Belviq was approved for use in combination with a reduced calorie diet and exercise program in patients whose BMI is:
- 30 kg/m² or greater (obese)
- 27 kg/m² or greater (overweight) if other weight-related conditions exists such as high cholesterol, high blood pressure, type 2 diabetes
Belviq works to produce a feeling of “satiety” or fullness through stimulation of the serotonin 2c receptor. Stimulation of this receptor is likely responsible for most of its side effects including some that are serious or even life-threatening.
Serious Belviq side effects include:
Belviq may cause changes in cognitive function including memory loss, attention deficits and confusion. Dizziness or drowsiness may also impair the ability to perform normal activities and caution should be used when driving or operating machinery.
Belviq may have a negative impact on mental health and some users may experience hallucinations, euphoria or dissociation. In addition, Belviq may contribute to worsening depression or bipolar symptoms and may increase the risk of suicidal thoughts or behaviors.
As Belviq is a serotonin stimulant, it may contribute to a condition known as serotonin syndrome which occurs when serotonin activity in certain areas of the brain is too high. It may be worsened or be more likely in patients taking other serotonin-type drugs including antidepressants, migraine medications and certain cold treatments.
Symptoms of serotonin excess may include:
- Changes in mental status
- High blood pressure
- Heart rate or rhythm changes
- High temperature
- Movement disorders
Serotonin syndrome may be serious or life-threatening and severe symptoms or those that occur suddenly should be treated as a medical emergency.
Common Belviq Side Effects
Other side effects are less severe and generally will go away with time. These may include:
- Dry mouth
Belviq Cancer Lawsuits
Belviq and Belviq XR have been linked to a slight increase risk of cancer in long-term users. The medication has been withdrawn from the U.S. market and the FDA has advised patients to discontinue using Belviq. Some people who were injured by Belviq may be considering filing a Belviq lawsuit against Japanese pharmaceutical manufacture, Eisai Inc.
People who have been diagnosed with pancreatic cancer, lung cancer, colorectal cancer or other cancers and who took Belviq or Belviq XR for an extended period of time may be eligible for compensation and should seek legal assistance.
- Belviq Prescribing Information, RxList (02/2020)
- FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market, U.S. Food and Drug Administration (02/13/2020)
- Safety clinical trial shows possible increased risk of cancer with weight-loss medicine Belviq, Belviq XR (lorcaserin), U.S. Food and Drug Administration (01/14/2020)