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Belviq
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Para 1: Obesity is leading cause of cardiovascular diseases. More than 30% of Americans are obese. This can be attributed to increase in junk food consumption habits. Para 2: Arena pharmaceuticals developed Belviq as anti-obesity pill. It was rejected by the EMEA on grounds that the information was not sufficient. However, Arena pharmaceuticals could not submit the requested information and decided to withdraw its marketing application. Shockingly, the FDA approved Belviq for marketing in the United States. Para 3: Belviq was actually rejected by the EMEA because it caused increased tumors in rat models when the drug was dosed for a period of two years. Belviq also has potential to cause cardiac valvulopathy which is undesirable in obese individuals. The FDA has recommended that the company conduct additional Phase IV studies to rule out the impact of cardiac valvulopathy in the long run. Belviq is unsafe in pregnant women too as it was found to decrease the weight of fetuses in animal models. Also, the drug has potential of dependency. Also, Belviq is a category IV controlled substance and its usage should be regulated to prevent addiction to the drug. The risk benefit ratio of the drug is low. Only 3-3.7% of weight reduction was observed in clinical investigations, of which 25% was gained back by the end of 60 days. So it is not entirely benficial to the obese individuals. Even the benefits observed in diabetic patients who were obese was minimal. Para 4: Given the risk profile of the drug and minimal benefits it seems like FDA acted hastily and approved Belviq. Instead of using
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Belviq is approved in USA but not in Europe.
Transcript of Belviq
Para 1:
Obesity is leading cause of cardiovascular diseases. More than 30% of Americans are obese. This can be attributed to increase in junk food consumption habits.
Para 2:
Arena pharmaceuticals developed Belviq as anti-obesity pill. It was rejected by the EMEA on grounds that the information was not sufficient. However, Arena pharmaceuticals could not submit the requested information and decided to
withdraw its marketing application. Shockingly, the FDA approved Belviq for marketing in the United States.
Para 3:
Belviq was actually rejected by the EMEA because it caused increased tumors in rat models when the drug was dosed for a period of two years.
Belviq also has potential to cause cardiac valvulopathy which is undesirable in obese individuals. The FDA has recommended that the company conduct additional Phase IV studies to rule out the impact of cardiac valvulopathy in the long run.
Belviq is unsafe in pregnant women too as it was found to decrease the weight of fetuses in animal models. Also, the drug has potential of dependency.
Also, Belviq is a category IV controlled substance and its usage should be regulated to prevent addiction to the drug.
The risk benefit ratio of the drug is low. Only 3-3.7% of weight reduction was observed in clinical investigations, of which 25% was gained back by the end of 60 days. So it is not entirely benficial to the obese individuals.
Even the benefits observed in diabetic patients who were obese was minimal.
Para 4:
Given the risk profile of the drug and minimal benefits it seems like FDA acted hastily and approved Belviq. Instead of using drugs like Belviq, people should instead focus on not eating junk food and not maintaining a sedentary lifestyle.
References:
http://www.belviq.com/documents/Belviq_Prescribing_Information.pdf
https://scholar.google.com/scholar?q=related:8MrDQYTDoIoJ:scholar.google.com/&hl=en&as_sdt=0,22
http://www.klinikfarmakoloji.com/files/EMEA%20FDA.pdf
USFDA. (2012). FDA approves Belviq to treat some overweight or obese adults. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm309993.htm
