FDA Advisory Committee Recommends Lorcaserin for Obesity

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A United States Food and Drug Administration (FDA) advisory committee recommended the approval of lorcaserin for the treatment of obesity. It was the second time the drug has gone before the advisory committee.

In 2010, lorcaserin received a negative review because of concerns about it causing cancer. New followup information was submitted by the drug’s manufacturer Arena Pharmaceuticals, and the FDA determined that the risk of tumors was “negligible.”

Lorcaserin Side Effects

Possibilities for side effects include hypertension in diabetics or heart valve damage. If the drug is approved, it may require patients getting echocardiograms to check their hearts a few times a year.

Lorcaserin and Qnexa for Obesity

Both lorcaserin and Qnexa could be the first prescription weight loss drugs for obesity in 13 years approved by the FDA. Coincidentally, both drugs have been recommended for FDA approval after previously being rejected by FDA advisory committees for safety concerns.

Qnexa is manufactured by Vivus, Inc and is a combination of topiramate and phentermine. Topiramate is an anticonvulsant that also goes by the brand name Topamax, and phentermine is a part of the fen-phen combination. Fen-phen, as you may recall, was removed from the market in 1997 amid concerns about heart valve issues and pressure in the lungs. The fen or fenluramine portion of fen-phen was considered the main problem, not the phentermine.

Side effects of Qnexa include a slight increase in heart rate, which could increase the chances of having a heart attack or stroke. An increase in birth defects, especially cleft lip was also associated with Qnexa in clinical trials.

In both Qnexa and lorcaerin, FDA advisory committees believe the benefits of weight loss outweigh the health risks of obesity.

How Much Weight Can You Expect to Lose with Lorcaserin or Qnexa?

On Qnexa, you can expect to lose an average of 10 percent of your body weight in one year. Lorcaserin users can expect to lose approximately 5 percent of their body weight within one year.

If lorcaserin and Qnexa are approved by the FDA, it’s expected the drugs will be prescribed for people who have a body mass index (BMI) of 30 or higher or a BMI of 27 or higher with weight related health issues such as diabetes and sleep apnea.

People with a BMI of 30 or higher are considered obese, and people who have a BMI of 25 to 29 are considered overweight. According to the Centers for Disease Control and Prevention (CDC), over 35 percent of adult Americans are obese.

The FDA is expected to make a decision about lorcaserin by June 27, 2012, and it is expected to make a decision about Qnexa by July 17, 2012.  

 

 

References:

“FDA Panel Recommends Lorcaserin for Obesity. TheHeart.Org.

“Arena Pharma Says it Plans New Stock Offering.” CBS News.

Lorcaserin Weight Loss Drug Wins Thumbs Up from FDA Panel.” Boston.com.

 

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