Earlier this year, the Food and Drug Administration approved in rapid succession two prescription drugs for weight loss in spite of opposition from health experts with Public Citizen. On June 27, the FDA approved lorcaserin, manufactured by Arena Pharmaceuticals, which was to be sold under the brand name Belviq. Fewer than three weeks later, the FDA signed off on the combination drug phentermine/ topimarate, made by Vivus, which was originally named Qnexa. Upon approval of the drug, Vivus announced it would market the pill under a new brand name, Qsymia. This was most likely because the drug’s dangerous side effects became well-known when the FDA rejected Qnexa in 2010, which was the first time Vivus submitted the drug to the agency for review.
Belviq and Qsymia are the first diet drugs the FDA has approved in 13 years. For years, Public Citizen has been warning the FDA about approving bad drugs where the risks greatly out-weighed any benefits. Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, observed:
It is magical and delusional thinking for anyone to believe that a drug will turn off hunger without hitting other internal targets where it will do harm, usually to the cardiovascular system. Has the FDA already forgotten why it pulled previous diet pills off the market?
Neither new diet pill is available on the market yet, but when they are, Public Citizen will immediately classify Belviq and Qsymia as “Do Not Use” drugs on its WorstPills.org website. As clinical trials have demonstrated, there’s good reason for extensive public debate about this class of drugs. The side effects of diet medications are serious, and the benefits are quite limited, typically amounting to just a few more pounds lost by patients taking drugs than by those taking a placebo. Dr. Wolfe had this to say:
There’s no need for the FDA to be reckless just because there is a desperate demand to solve the obesity crisis – a multilayered health, culture and food industry issue that has developed over decades.
Research shows that Belviq increases heart rate and can create heart valve problems. During clinical trials, four patients on the diet pill had nonfatal heart attacks, while no patients on the placebo experienced heart trouble. In a last-ditch effort to keep Belviq off the market, Public Citizen appealed to FDA Commissioner Margaret Hamburg on June 26, reminding her of the drug’s negative consequences and warning that approval would be “a mistake that will benefit only the company that makes it.”
That very same day, the Annals of Internal Medicine published an online recommendation against the use of any diet drugs due to safety issues, underscoring the reality that dieters cannot keep off the weight they lost by taking diet medications. But the FDA approved the drug anyway.
Qnexa also can cause a host of dangerous side effects, including kidney stones, pancreatitis, birth defects (such as cleft lip or palate), cognitive impairment and metabolic acidosis, a known risk factor for heart arrhythmia. In February, Dr. Wolfe testified before a meeting of the FDA Endocrinologic and Metabolic Drugs Advisory Committee urging the agency to reject Qnexa for a second time.
Over the past 15 years, the FDA has been forced to ban several weight-loss drugs it had previously approved because of clear-cut evidence that they increased cardiovascular risk. The drugs that were banned include:
• sibutramine (Meridia) because it increased the risk of heart attacks and strokes;
• the combination drug fenfluramine/dexfenfluramine (Redux) because of heart-valve problems;
• ephedra because of heart attacks and strokes; and
• PPA (phenylpropanolamine) because of bleeding strokes.
The only currently available diet drug approved by the FDA in the past 20 years came out in 1999. Orlistat, sold as Xenical and made by GlaxoSmithKline (GSK), was hailed as a breakthrough drug. After it was in wide circulation, evidence that it caused liver damage began to surface. When the market eventually became saturated and sales dwindled, GSK sought and received approval in 2007 to sell an over-the-counter version of Xenical, called Alli.
On two separate occasions in the past few years, Public Citizen petitioned the FDA to ban Orlistat, but it’s still on the market today. The drug’s common side effects, which occur almost immediately, include diarrhea, frequent or loose stools, gas with discharge, oily spotting and uncontrollable bowel movements. Even so, GSK estimates that it has sold its diet drugs to 40 million people worldwide. Finally, Dr. Wolfe had this to say on the subject:
Obesity is unquestionably a serious public health concern, but that doesn’t give the FDA license to ignore the scientific evidence when it outweighs and contradicts any reason to approve a drug for human consumption. Besides, it’s common knowledge that the true path to weight loss consists of a long-term program of healthy eating combined with regular exercise.
The American people must wake up and demand that the FDA stop putting dangerous drugs on the market. Public Citizen is leading a charge on this front, but it needs troops to follow along. Hopefully, once folks realize how many dangerous drugs have been approved by the FDA, they will get involved and demand action by both the FDA and Congress. It’s quite obvious that the drug industry is taking advantage of folks who want to lose weight the easy way. The marketing arms of the companies see the potential for making huge profits. It’s up to the FDA to control their activities.
Source: Public Citizen News
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