It promises to help patients lose five-to-ten percent of their weight (according to clinical trials) when combined with diet and exercise. But is this what America’s overweight patients really need?
Lorcaserin, the drug name for the prescription diet pill Belviq, was approved by the FDA today, making it the first weight loss drug to receive such approval since Orlistat (Alli) in 1999. This comes just weeks ahead of what is anticipated to be an FDA approval for Qnexa, another weight loss drug.
“In two clinical trials, Lorcaserin helped patients lose 5.8 percent of their body weight after a year. That’s about ten pounds for a 180 pound person. Big deal,” said our resident dietitian Mary Hartley, RD.
The drug works by controlling the appetite by making the brain think its fuller sooner. It’s fared well in clinical trials, and will have to undergo six more studies after its in market to ensure long-term cardiovascular health and to determine Belviq’s risk factor for heart attack and stroke. This makes the in-market patients unassuming guinea pigs, according to Hartley, and that isn’t right.
“The advisory committee decided that the benefits of the drug outweighed the risks heart value problems, but the drug manufacturer was made to conduct post-marketing studies to assess long-term cardiac events such as heart attack and stroke. That makes the patient a guinea pig. No thanks.”
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UPDATE: 6/27/12: Lorcaserin, which will be sold as Belviq, received FDA approval today, making it the first diet pill the government agency has approved in more than a decade. Learn more about Lorcaserin.
In the midst of controversy over the weight loss drug Qnexa, a new drug has entered the arena of consideration after it was approved by an FDA advisory panel on Thursday.
The new drug, Lorcaserin, is made by Arena Pharmaceuticals and claims to control appetite through receptors in the brain. Experts tout its clinical trial results showed nearly half of participants lost up to five percent of their body weight.
The FDA committee approved the drug by a favorable vote of 18-4, and the FDA is slated to decide on its official approval by June 27.
Much like Qnexa, Lorcaserin was rejected in 2010 by the FDA advisory committee over numerous health concerns, including brain and breast tumors in rats during trials, as well as heart valve problems. However, these concerns dissipated after clinical trials showed these side effects did not appear on overweight and obese humans. The adverse effects experienced by those taking a 10 milligram dose of Lorcaserin included headache, dizziness, nausea, fatigue and dry mouth.
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UPDATE 7/17/12: Qnexa was approved by the FDA on July 17, 2012. This marks the second weight loss drug approval in 2012; the first weight loss drugs approved since Alli in 1999. The prescription drug will be sold as Qsymia.
The inmates are running the asylum. Reversing an earlier decision, the medical experts on FDA’s Endocrinologic and Metabolic Drugs Panel cleared the way for approval of the new diet drug Qnexa. Qnexa (PHEN/TPM) is a combination of phentermine and topiramate (PHEN/TPM). Topiramate is used to treat seizures and prevent migraine headaches and phentermine is approved for the short-term treatment (i.e. a few weeks) of obesity. PHEN was half of PHEN/FEN, the discontinued diet drug that led to valvular heart disease and potentially fatal pulmonary hypertension, primarily in women. Qnexa is indicated for “BMI greater-than or equal to 27 kg/m2) with weight-related co-morbidities such as hypertension, type 2 diabetes, dyslipidemia, or central adiposity (abdominal obesity),” the group with the highest heart disease risk.
The panel decided that the complications of obesity outweighed the risk of heart problems. It’s hard to believe they were swayed by the research. The 2010 study published in the Lancet reported that people who took the highest dose of Qnexa (not the lower approved dose) lost at least 10% of their body weight and showed improvements in their risk cardiac factors. Clinical trials by the manufacturer showed 45% of subjects treated at the low dose lost > 5% of baseline body weight following one year of treatment. No one seems to care that we’re talking about a 10 to 15 pound weight loss on a 200 pound person. Do we need a drug for that, especially one that comes with heart disease risk? No matter because the results showed statistical significance in a placebo control study.
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The Food and Drug Administration (FDA) is advising consumers not to purchase or use “Japan Rapid Weight Loss Diet Pills Green.” This product is used for weight loss and sold on various websites, such as Amazon.com and distributed by Xiushentang.
According to the FDA website, a laboratory analysis confirmed that “Japan Rapid Weight Loss Diet Pills Green” contains undeclared phenolphthalein.
According to the Britannica, Phenolphthalein is a potent laxative, which acts within 6–8 hours; its effects may last 3–4 days. Such adverse reactions as kidney irritation or skin rash may occur. As an indicator of the pH of a solution, it is colorless below pH 8.0 and attains a deep red hue above pH10.0.
It was discovered in 1871 by the German chemist Adolf von Baeyer, who prepared it by fusing phenol and ophthalmic anhydride in the presence of sulfuric acid or zinc chloride. This is a solution used in chemical experiments and is also suspect of causing cancer.
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Qnexa, a diet pill created by Vivus, Inc., that claims to help dieters lose 10% of their weight when combined with diet and exercise, has been approved by the FDA advisory panel in a landslide vote of 20-2.
The panel had previously rejected the the pill due to safety concerns, which has left its opponents concerned. Since the FDA typically follows the advice of its advisory panel, the drug is likely to be approved by mid-April.
Previous concerns about the drug are still present. And if the pill does go on shelves, potential users should be aware of that. One of Qnexa’s main ingredients is phentermine, a type of amphetamine that stimulates the nervous system and increases heart rate and blood pressure. It’s commonly used in diet pills since it suppresses appetite, and was woefully recognized as the “Phen” in the weight loss drug Fen-Phen, which was yanked from the market by the FDA in 1997 after being deemed too dangerous for consumption.
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