In February, the manufacturer of the weight-loss drug lorcaserin (Belviq, Belviq XR) voluntarily withdrew the drug from the U.S. market. FDA application. It was the results of emerging data showing an increased incidence of cancer after five years in individuals who took the drug as part of a giant clinical trial.
What were the findings about Belviq, and why is that this information coming out now?
Lorcaserin was approved by the FDA in 2012. As a part of the approval process, the FDA reviewed a series of clinical trials that checked out its effects on weight and its safety profile in comparison with a placebo.
Based on these studies, the drug was approved, however the FDA mandated a bigger study to evaluate its cardiovascular safety. on this Later studiespublished in New England Journal of Medicine12,000 individuals with chubby or obesity and heart problems (CVD) or CVD risk aspects took either lorcaserin or a placebo. During a three-year follow-up, as published in 2018, those that took lorcaserin had greater weight reduction and comparable rates of cardiovascular events than those taking placebo. So from a cardiovascular safety perspective, the study was reassuring.
But the study subjects continued to be followed, and what was recently revealed is that at five years, the group that took the drug had a rather higher incidence of cancer than the placebo group. (7.7% of lorcaserin subjects developed cancer compared with 7.1% within the placebo group). An increase was seen in several several types of cancer, including pancreatic, colorectal, and lung.
Where does withdrawal leave people who find themselves currently taking Belviq?
Based on the evidence we now have, it remains to be uncertain whether lorcaserin actually increases the danger of cancer. And we don't know anything in regards to the mechanism by which this drug can have these effects. It can also be necessary to reiterate that this potential increase within the presence of cancer may be very small. 7.1% of individuals got cancer in the event that they were taking placebo, and seven.7% in the event that they were taking lorcaserin.
That said, people taking lorcaserin are advised to stop taking it and call the doctor who prescribed it for guidance on next steps. The FDA will not be currently recommending any specific cancer screening or other testing.
Can my doctor prescribe one other weight reduction medication?
Loracaserin is one in all several drugs currently approved by the FDA for weight reduction in people who find themselves chubby with weight-related medical problems, or who're obese. For those that haven't been successful in shedding weight through food regimen, exercise, and other healthy lifestyle changes, or for individuals who are unable to take care of weight reduction, weight reduction Medicines can play a vital role. By changing the biology of weight-control systems, and by suppressing appetite and cravings, drugs may help people drop some weight even when other strategies haven't worked. For example, Lorcaserin works by affecting the brain's serotonin signaling, which makes you are feeling fuller, so that you eat less.
However, because each drug works in a novel way, someone who experiences weight reduction with lorcaserin may not necessarily experience the same effect with one other drug. You might have to work along with your doctor to try different options which are effective.
Do the brand new findings mean all weight reduction drugs are unsafe?
These recent findings by no means reflect the protection of other weight reduction medications in the marketplace. Weight-loss drugs have a storied history with safety recalls, and lorcaserin will not be the primary weight-loss drug to be pulled from the market after years of patient use—fenfluramine/phentermine (Fen-Phen) and sibutramine. (Meridia) are others. Examples
Still, it's troubling to learn that a widely used, FDA-approved drug poses serious safety concerns. On the opposite hand, it can be crucial to indicate that, as within the case of lorcaserin, the FDA evaluates the protection results, and continues to strictly monitor the product in the marketplace. This is in contrast to weight reduction supplements, which will not be regulated by the FDA. Americans spend tens of millions of dollars every year on these unregulated weight reduction products, which produce unbelievable results, with none credible studies or ongoing safety monitoring, and which may have serious negative health consequences. are
Anyone considering weight reduction medications or products should work with a licensed health care skilled. The experience with lorcaserin is an excellent reminder to only use interventions which have scientific studies that evaluate safety in addition to advantages. And it's reassuring that close monitoring and regulatory processes are in place to make sure our safety.