Why the FDA Wants Weight Loss Drug Belviq Withdrawn

Why the FDA Wants Weight Loss Drug Belviq Withdrawn

Belviq was the first prescription weight loss drug to win FDA approval in 13 years. Unfortunately, a clinical study has since linked it to a higher rate of cancer in patients. The FDA requested it be removed from the U.S. market and manufacturing was swiftly halted.

What is Belviq?

The compound lorcaserin, commonly under the brand name Belviq, is a weight loss drug that was prescribed to people with dangerously high BMI. It theoretically suppresses appetite by modifying the serotonin levels in the brain.

Composition

Belviq’s primary active ingredient is lorcaserin. Lorcaserin is in the class of drugs called serotonin receptor agonists. Each tablet of Belviq contained 10.4 mg of crystalline lorcaserin hydrochloride hemihydrate, which from here on will just be referred to as lorcaserin. The rest of Belviq’s ingredients were standard inactive ingredients that facilitate the tablets’ shape and edibility.

Uses

By altering the serotonin, the drug attempts to suppress a patient’s appetite which should lead to weight loss along with physician-approved exercise and lifestyle changes. Any drug that changes the chemical composition and function of the brain requires a lot of physician oversight to be safe.

Belviq also required a 12-week follow-up with patients to determine efficacy; in some cases, a patient simply saw no benefit.

The Problems with Belviq

Weight loss drugs have a long history of causing unintended and usually dangerous effects in patients. Belviq was the first prescription weight loss drug to earn FDA approval in over 13 years, but the key to weight loss still eludes pharmaceutical companies.

Lorcaserin

The active ingredient in Belviq, lorcaserin, had a long and troubling road to approval. Now that FDA approval has been withdrawn, it makes you wonder why it was ever approved.

Early testing on animals, before Belviq was ever for sale, showed a prevalence of tumors in rats. The marginal at best efficacy of the desired weight loss effect and the risk of a carcinogenic led the FDA to deny the drug.

In 2012, though, the drug was pushed through under heavy restrictions for its use. Belviq was then the subject of numerous studies concerning the effectiveness and risks of lorcaserin. In 2016, an extended-release version was also brought to market.

The higher rates of cancer in patients who took Belviq have led to a slew of legal action against the manufacturer Eisai. If you or someone you love has taken Belviq, seek a medical professional and then reach out to a Belviq lawsuit lawyer.

Side Effects and Drug Interactions

Belviq has few simple interactions to avoid, but instead, it carries the risk of slowing down your body’s processing of many other medications. If you take Belviq with another medication, it may slowly build up chemical levels in your body to a dangerous level. Belviq also occasionally triggered a severe allergic reaction.

The side effects that Belviq could have were quite serious. Serotonin is the main hormone that regulates and stabilizes mood and feelings of well-being. Tampering with the body’s natural levels for weight loss left some patients with mood swings, depression, confusion, agitation, and sometimes even thoughts of suicide.

There are many other, lesser side effects of taking Belviq, from muscle cramps to headaches. Ask a physician for the full list of side effects if you have taken Belviq and experienced a negative reaction.

FDA Removal

In January 2020, the FDA reviewed a clinical trial that was a contingency for lorcaserin’s approval. The five-year study found that across 12,000 patients given either Belviq or a placebo, cancer appeared more in the group given Belviq. This caused the FDA to revoke their approval of Belviq and other lorcaserin products and request that they were immediately removed from the US market.

When the FDA requested the lorcaserin manufacturer Eisai voluntarily remove the products from the market, they quickly complied.

The Future of Weight Loss Drugs

While the Belviq experiment proved too dangerous for widespread use, many pharmaceutical companies are currently working on new compounds for weight loss. If you took Belviq, immediately consult with your doctor about the best alternative and when you can stop.

 

 

 

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