Eisai, Inc. voluntarily pulled its weight-loss drug Belviq from the market in February 2020 after it was determined that the drug poses a slightly increased risk of cancer. Despite the recall of the product, Eisai said it did not believe the FDA’s interpretation of the latest round of data on the drug’s safety and stated that it still believes the benefits outweigh the risks.
According to the FDA, patients currently using Belviq should stop doing so immediately. They should dispose of any remaining pills and speak to their doctor if they would like an alternative weight loss drug. The FDA also recommended doctors notify their patients using the drug of the risk.
Belviq received approval from the FDA in 2012. It was one of a few weight loss drugs to come on the market that year. None offered the results hoped for by drug companies, but these drugs did serve as an option for those struggling with obesity and its side effects.
Hopes were especially high for Belviq, as it was the first drug to help people drop excess pounds and keep them off for several years without triggering any subsequent heart health problems. These positive results came at the conclusion of a five-year study that included 12,000 Belviq users. This post-approval follow-up was required by the FDA.
However, the high hopes were short-lived after it was determined that Belviq users had a nearly 8% higher risk of developing a range of different cancers. Patients in the follow-up study had developed lung, colorectal, and pancreatic cancer more frequently than those subjects in the comparison group not using Belviq.
According to the FDA, no special cancer screening was needed for those who took Belviq. The increase in cancer risk was only present in those who took the drug for extended periods.
Eisai stands by its drug, claiming that its benefits outweigh its risks when taken as directed by people struggling with obesity. Belviq is approved for adults with BMIs 30 and over and for adults with BMIs 27 and over who have co-occurring conditions, such as type 2 diabetes, high blood pressure, or high cholesterol.
Why Some Patients Were Willing to Risks Using Belviq and Other Potentially Dangerous Weight Loss Drugs
In addition to any vanity reasons for wanting to shed extra pounds, many people using Belviq and other weight loss drugs were willing to risk developing other health issues because of the tremendous risks they already faced due to being overweight.
According to the CDC, being overweight or obese increases a person’s risk of:
People who have obesity, compared to those with a normal or healthy weight, are at increased risk for many serious health concerns, including the following:
- High blood pressure
- Type 2 diabetes
- High LDL cholesterol, low HDL cholesterol, or high levels of triglycerides (Dyslipidemia)
- Coronary heart disease
- Gallbladder disease
- Sleep apnea and breathing problems
- Many types of cancer
- Reduced quality of life
- Mental illness including depression, anxiety, and other mental disorders
- Body pain
- Difficulty with physical functioning
- All-causes of death (mortality)
Most recently, obese people who contracted the COVID-19 virus suffered a higher rate of unfavorable outcomes over people who were within a healthy weight range.
During pre-approval testing, half of the patients using Belviq lost at least 5% of their body weight within the course of one year of use. A quarter of those using Belviq lost at least 10% during that same time frame.
Belviq produced similar results to Contrave, another weight loss drug introduced around the same time. However, users of Contrave reported experiencing suicidal thoughts and behaviors while using the drug. It did not perform as well as Qsymia, the third of the weight loss drugs to hit the market in 2012. Belviq was also more expensive than Qsymia by approximately a third.
Both the original and extended-release versions of Belviq have been pulled from the market.
Learn the latest on Belviq lawsuits here.