FDA grants approval for Belviq - Prescription Weight Loss Pill

Prescription medicine - BSN

(Best Syndication News) - The US Food and Drug Administration (FDA) announced the approval of approved Belviq (lorcaserin hydrochloride) for overweight and obese people who also have either high blood pressure (hypertension), type-2 diabetes, or elevated cholesterol levels (dyslipidemia).

In order to qualify for the weight loss medication, the person's body mass index (BMI) needs to be greater than 27 (this is considered overweight). A BMI over 30 is considered obese. There also has to be a secondary condition such as high blood pressure, high cholesterol, or type 2 diabetes present. According to the US Centers for Disease Control and Prevention (CDC) over one-third of the US adult population is considered obese.

In addition to the Belviq medication, it is to be used in conjunction with a reduced-calorie diet and exercise program.

Belviq causes the serotonin 2C receptor to become active in the brain. This activation could aid the person in weight loss efforts because they could feel full from eating less and could also help them to eat less in general.

The trial study involved 8,000 participants that were overweight, obese, and some had type 2 diabetes while others did not. The study lasted for 52 to 104 weeks. One group received the Belviq, while another group received a placebo pill.

All the participants received lifestyle modifications that included a lower calorie diet and information about exercising.

The results of the trials showed weight loss of 3 percent to 3.7 percent in the overall group taking Belviq. Around 47 percent of the participants that did not have type 2 diabetes lost at least 5 percent of their bodyweight compared to 23 percent that were given a placebo pill. Those participants that had type 2 diabetes had 38 percent of the Belviq group lose over 5 percent of their body weight compared to 16 percent in the placebo group who lost over 5 percent of their bodyweight.

The FDA approved Belviq for long-term use only if a person can lose 5 percent of their bodyweight in the first 12 weeks of treatment. The reason is that if the weight loss has not occurred, then the diet pill probably will not help them enough over the long-term.

Belviq is not to be used when pregnant. There are serious side effects from taking Belviq; this includes serontonin syndrome. Another problem is that Belviq could cause attention or memory problems.

Back in 1997, there was a problem from fenfluramine and dexfenfluromine because they were suspected to have caused heart valve damage. These drugs activated the serotonin 2B receptor, which caused damaged to the heart tissue.

Belviq participants in the trail were tested for heart valve damage and the research did not see any significant difference from the placebo group. However, Belviq’s preliminary data showed an increase in serotonin 2B receptors in congestive heart failure patients. Additionally, Belviq was not studied in people with valvular heart disease.

Belviq’s drug manufacturer will be required to conduct six more studies to assess the long-term cardiovascular safety, such as if there is any increased risk for heart attack or stroke caused from the medication.

By: Marsha Quinn
Health Reporter

ref: FDA

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