Pharmaceutical companies market weight loss pills to people who need hope that there is an easier way to lose weight. While some of these pills can end up being effective, weight loss drugs have also been associated with some of the biggest failures ever in the pharmaceutical industry. Fen Phen caused scores of deaths as well as other heart injuries and resulted in one of the largest class action settlements of all time. Now, there is negative news about another weight loss drug. Specifically, the FDA is informing the public that the weight loss drug Belviq is potentially tied to an increased risk of cancer. This is not a final conclusion from the FDA which intended this warning to inform the public at an early stage of a potential finding.
The Troubled History of Belviq Continues
Belviq has had a troubled history since it was first developed by Arena Pharmaceuticals. The initial application was filed with the FDA in 2009 and the regulator voted against approving it. At the time, the FDA stated that cancer could not be ruled out as a side effect of the drug and that its potential effectiveness was “marginal.” Three years later, based on new studies, the FDA decided to approve the drug, albeit with certain restrictions. Belviq was not approved for use in Canada as the company could not satisfy the concerns of Canadian regulators. Belviq also failed to obtain approval from European regulators, making the FDA approval an outlier.
Even with the negative publicity and possible side effects, Belviq was initially hailed as a wonder drug. Belviq affects how you feel, making you experience the feeling of being full in order to cut back on how much you eat. In the case of Belviq, the commentators ascribed to the drug more effectiveness than it actually has in reality. While taking Belviq does result in some weight loss, the actual results do not seem to live up to the hype.
While Belviq was shown to be effective to an extent in post-approval trials, sales of the drug never really got off the ground. Arena Pharmaceuticals bailed on the drug in 2017, selling its rights in the drug to the Japanese company Eisai Co, Ltd. By that time, Belviq was already classified as a controlled substance due to the fact that it had hallucinogenic properties.
This Study Was Required by the FDA
It is against this backdrop that the FDA’s latest pronouncement rattled an already fragile market for Belviq. When the FDA approved the drug, it required the manufacturer to conduct post-approval studies of the safety of the drug. The findings announced by the FDA were the results of one of these clinical studies.
The study included 12,000 patients who were taking Belviq over a five-year period. According to the FDA, more patients who were taking Belviq developed cancer than those who were taking a placebo. This led the FDA to believe that there may be a problem, at least enough to inform the public.
What Was in the FDA Safety Communication
There were no concrete results or conclusions that were released from the study. However, the FDA said that it could not rule out the possibility that Belviq is a carcinogen. The communication from the FDA was laced with uncertainty, but the FDA just wanted the public to be aware that it was investigating further. Now, the FDA is in the midst of a more extended review and the agency promises to communicate its findings to the public when the study is complete and the conclusions are available.
According to the FDA’s Drug Safety Communication, physicians are encouraged to reevaluate whether the benefits of Belviq outweigh the possible risks in light of these new possible risks before either prescribing the drug for the first time or writing a continuing prescription for a patient. If you are a patient who is currently taking Belviq, make sure that you have a conversation with your physician about whether continuing on the drug is the most prudent course. The FDA did not tell people to stop taking the drug yet because it does not yet have conclusive information, but it still wants physicians and patients to reevaluate their courses of action. In the meantime, the FDA asked that physicians inform it of any side effects that patients encounter while it is undertaking the further study of the drug.
The drug’s maker promised that it would work with the FDA as it evaluated the results of these studies. The company has not challenged the FDA’s Safety Communication and urges patients to work with their physician to find the best possible solution for their own issues. It is likely that most doctors will cease prescribing Belviq to their patients.
Weight loss drugs in general are relatively rare after the large-scale issues surrounding Fen-Phen. Including Belviq, there are only five approved weight loss medications on the market. Physicians will normally advocate that patients try to lose weight through changes in diet, lifestyle and exercise. In fact, Belviq was the first weight loss pill that the FDA had approved in 13 years. The FDA will likely give close scrutiny to future diet drugs given all of the issues surrounding these medications. Numerous other weight loss pills on the market have been associated with significant issues such as birth defects, heart attacks and strokes. For many of these drugs, the complications far outweigh the limited benefits that the medications offer.
At this point, there are no concrete findings but lawsuits may soon be filed against the maker of this product based on the FDA Safety Communication. Those who have taken Belviq and been diagnosed with cancer will likely soon be filing lawsuits seeking financial compensation for their injury. If you have taken Belviq and have developed cancer, contact the attorneys and Sadaka Associates to discuss your case. You should also consider your legal options if you have taken any other weight loss drug and suffered an injury from the use of the product.
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