FDA

Despite health risks, two new weight loss drugs get FDA approval

Wednesday, August 22, 2012 by: Daniel C. Mizzi
Tags: weight loss drugs, FDA, health risks

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Delicious
(NaturalNews) Obesity is a leading health problem in the U.S. with nearly two thirds of all adults either being obese or overweight. In an effort to profit from this crisis, two new weight loss therapies "Qysmia" (formerly known as Qnexa) produced by Vivus Pharmaceuticals and "Belviq" (Lorcaserin) manufactured by Arena Pharmaceuticals recently received FDA approval.

What are the safety concerns of Qysmia and Belviq?

In summary, both therapies were initially rejected by the FDA due to safety concerns, are contraindicated during pregnancy, may cause withdrawal-like side effects if the medication is stopped abruptly, as well as, having potentially devastating cardiovascular and neurological side effects. Furthermore, both drug companies needed to meet additional requirements set forth by the FDA to help ensure the safety of each agent before they would grant FDA approval.

With respect to Qysmia, its most serious health concerns are linked to causing birth defects, metabolic acidosis, elevation in heart rate, kidney stones, dizziness, numbness in hands, arms, face or feet, and significant cognitive impairment including loss of memory, concentration and language skills. In addition, when research participants received higher doses of the drug, they were twice as likely to experience sleep disorders, anxiety, depression and irregular heart rhythms than those who received the placebo. In an effort to allay these potential risk factors, the FDA ordered Vivus Pharmaceuticals to develop a Risk Evaluation and Mitigation Strategy (REMS) that involved developing special prescriber and pharmacist certification/training programs along with a patient safety/education medication guide http://gregnguyen.blogspot.com/2012/07/qysmia-medication-guide.html). However, despite these safety initiatives, it is worth to point out that four trial participants who used Qysmia experienced non-fatal heart attacks during the research......while no one experienced heart attacks in the placebo group.

On the other hand, some of Belviq's most concerning health risks relate to the possibility it may cause heart valve defects, ability to reduce red and white blood cell counts, reduce heart rate, cause considerable cognitive impairment (drowsiness, confusion, worsening memory and attention) and the possibility of causing a serious condition called serotonin syndrome (especially when it is used in conjunction with other drugs like certain antidepressants and anti-migraine drugs that can elevate serotonin levels or activate serotonin receptors). Also, animal studies show that Belviq has a tendency to cause cancerous tumors in rats. In light of these health concerns, Arena Pharmaceuticals, as part of their FDA's approval process, agreed to conduct six post-marketing studies, including a long-term cardiovascular outcomes trial to assess the effect of Belviq on the risk for developing major adverse cardiac events such as heart attack and stroke.

The bottom line

Although, both of these drug therapies may help reduce a minimal amount of body weight (if taken continuously along with diet and exercise)both of these drugs offer little to solve the obesity pandemic long-term. Furthermore, little is known about their long-term safety and health risks. Thus, more effort should be placed on trying to treat the root causes of obesity (rather than focusing on drug profits) which involves making changes in our diet/exercise habits, getting enough sleep, alleviating hormonal imbalances that can contribute to weight gain, as well as, ensuring safer and healthier global food supplies.

Sources for this article include:

http://www.cdc.gov/nchs/data/databriefs/db82.pdf
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022529lbl.pdf
http://www.pharmpro.com
http://healthland.time.com
http://vitals.nbcnews.com
http://seattletimes.nwsource.com
http://www.ncbi.nlm.nih.gov/pubmed/15145308
http://healthfinder.gov/News/newsstory.aspx?docid=666835
http://www.forbes.com
http://www.drugs.com/phentermine.html
http://clinical.diabetesjournals.org/content/25/4/135.full
http://docnews.diabetesjournals.org/content/2/1/5.full
http://www.latimes.com
http://www.nature.com/ijo/journal/v31/n7/full/0803548a.html
http://www.ncbi.nlm.nih.gov/pubmed/12678838
http://gregnguyen.blogspot.com/2012/07/qysmia-medication-guide.html
http://healthland.time.com
http://www.ncbi.nlm.nih.gov
http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=3661
http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=3643

About the author:
Daniel C. Mizzi, R.Ph., Pharm.D.
Registered clinical pharmacist/staff writer with a sincere interest in natural/integrative medicine and author of the blog-site "The OTC Guide to Common Medical Conditions" http://otcguide.blogspot.com/.

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