Rockville - After sibutramine, which was in the U.S. until the beginning of the month has pushed the market, the U.S. Pharmacopoeia Drug Administration two other diet pills issued a denial: lorcaserin and the combination of Diphentermin / topiramate, the license was denied.
Early October, as reported by the manufacturer Abbott Meridia ® (active ingredient: Sibutramine) in North America and Australia voluntarily from the market. He came to a ban by the FDA before. The European Pharmacopoeia Authority EMA had been suspended in January 2010, the approval of Reductil ® with the same active ingredient.
The cause was the small effect of sibutramine coupled with an increase of cardiovascular complications in "Sibutramine Cardiovascular Outcomes Trial" (SCOUT). The patients lost less than 5 percent of body weight, and then also affected more often from heart attacks or stroke, which should protect against a medically indicated diet pill really.
On 23 October was then Arena Pharmaceuticals of San Diego Post by the FDA.The authorities complained that the reduction of excess weight had broken down in non-diabetic people with overweight or obesity only marginally.
In addition, the final results of "behavioral modification and lorcaserin for Overweight and Obesity Management in Diabetes Mellitus" or lay BLOOM-DM trial in diabetic patients not yet available. The study was completed in May 2010. A publication is pending. The manufacturer announced it now for the next few weeks.
The primary endpoint was a reduction in body weight by 5 percent, which the FDA has set as a condition of approval. For the medical benefits but should also be the results in the secondary endpoints of the influence on HbA1c, blood pressure and lipid metabolism is important.
Valvular heart disease among lorcaserin: diet pill lowers HbA1c
The FDA is also concerned about a possible cancer risk: In preclinical experiments, it was in female rats had increased to breast cancer - humans certainly no unacceptable adverse effect of diet pill.
Even with the third drug safety concerns are paramount. The FDA refused on 28October 2010, the approval of Qnexa ® by Vivus in Mountain View / California off, although the two drugs in the United States has long been on the market.
Phentermine was approved in 1959 by the FDA as an appetite suppressant. It is even touted as a generic. In the 90s there was a component of "Fen-Phen", which was banned because of an increased rate of heart valve defects. This complication, however, was the fenfluramine ("fen") attributed. Phentermine ("phen") was classified as harmless.
The second component of Qnexa is the anti-epileptic drug topiramate, which triggers a side effect of weight loss. As a combination of phentermine and topiramate are about twice as effective as sibutramine or lorcaserin. The participants in the clinical studies, an average of 10 percent of body weight.
Both agents have side effects: Phentermine increases heart rate, topiramate can interfere with concentration and memory, increase the risk of suicide and induce a metabolic acidosis and kidney stones. It is also suspected to be teratogenic.
This may be tolerable when used as anti-epileptic drug. With a diet pill that fell so much weight that the external reviewers of the FDA in July 2010 with 10 votes to 6 against the admission uttered. The FDA has now joined this vote.
After three years of Acomplia ® (active ingredient rimonabant) has been taken due to an increased risk of suicide from the market, is currently only with the active ingredient orlistat, Xenical ® on the market. It inhibits the breakdown of fats in the intestine and thus their absorption, but this can lead to the patient unpleasant greasy stools (steatorrhea).
For December 2010, the FDA has scheduled an advisory meeting on Contrave ®, a combination of bupropion and naltrexone. Should not this drug will be approved, the manufacturer should slow the interest in developing lose from diet pills - and leave the market to the illegal suppliers of products containing the banned drugs such as sibutramine, which in recent months repeatedly offered in the Internet and from theauthorities had to be confiscated.
