There are mixed reviews about the recent approval of lorcaserin (Belviq) and its new availability as a prescription weight loss drug. Obesity has become an epidemic in the United States and across the world and the maker of lorcaserin, Arena Pharmaceuticals, will market this drug as a supplement to drug and exercise to help patients reach their weight loss goals faster. Every drug has side effects and I felt it was important to look closer at some of the possible reactions.
Lorcaserin activates the serotonin 2C receptor which helps you eat less and feel full sooner. Previous weight loss drugs activated the 2B receptor and caused damage to heart valves. Cardiovascular health will be monitored once this hits the market to ensure no damage to the heart valves occur, as there were concerns about this in trials. In October 2010, lorcaserin was rejected by the FDA due to a cancer signal being detected. It caused mammary tumors in rats, which the makers believe is related to the animal themselves and should not have the same effect in human subjects (although prolactin levels can become increased in humans leading to breast development in men and lactation in women).
Multiple studies had patients with and without diabetes treated long term for one to two years with nearly 8,000 patients participating. Those who were randomized with lorcaserin along with diet and exercise counseling lost 3 to to 3.7 percent more weight. The drug should be discontinued if the patient does not lose at least five percent of their body weight in the first twelve weeks.
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Alli was the first FDA approved diet pill to hit the market and experienced a shortage recently. “We had experienced a supply shortage of the active ingredient used to make the product,” a representative from GlaxoSmithKline Consumer Healthcare said in an email. “The supply issue has been resolved.”
The active ingredient they are referring to is orlistat. It helps with weight loss by suppressing the body’s ability to absorb fat in the intestines and can block up to 25 per cent. When the body is unable to absorb the fats they become undigested waste.
Studies on the amount of weight loss you can lose with Alli are limited but you can expect to lose three to five pounds more a year than if you were relying on diet and exercise alone.
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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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