22 January 2010 - US Abbott Laboratories (NYSE: ABT) said yesterday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA, formerly known as EMEA) voted to recommend the suspension of marketing authorisations for all anti-obesity medicines containing sibutramine
Tests on Chinese Jia Yi Jian tablets revealed appetitesuppressant sibutramine
and impotence drug tadalafil.
An FDA analysis found that the undeclared active pharmaceutical ingredients in some of these products include sibutramine
(a controlled substance), rimonabant (a drug not approved for marketing in the U.S.), phenytoin (an anti-seizure medication), phenolphthalein (a solution used in chemical experiments and a suspected cancer causing agent) and bumetanide (a diuretic).
Another 10 studies focused on drug interventions with metformin, orlistat, and sibutramine
. The review, which is an updated version of one first published in 2003, was published online in The Cochrane Library this year.
Rimonabant will be made available to overweight or obese patients who cannot take, or who have had no success with, two other drugs, orlistat and sibutramine
The food intake study comprised 36 overweight males (mean age 37 years) who, after a 13-hour fast, received 4 mg of taranabant, 12 mg of taranabant, 30 mg of sibutramine
, or placebo, in crossover fashion.
A review of studies on the drugs showed a mean weight loss for people on sibutramine
of 9.8 pounds at 52 weeks; orlistat, 6 pounds at 52 weeks; phentermine, 7.9 pounds at 2 to 24 weeks; bupropion, 6 pounds at 24 to 52 weeks; topiramate, reported as 6.5 percent of pretreatment weight lost at 24 weeks; diethylpropion, 6.6 pounds at 6 to 52 weeks; and fluoxetine, which had ranges from 32 pounds lost to almost 1 pound gained at 52 weeks.
While Dr Sheperd's review of obesity management ("Effective management of obesity," 2003; 52(1):34-42) is timely and appropriate, given the significant impact of this problem for both the individual and society, unfortunately his brief review of sibutramine
therapy contains an inaccuracy.
Reductil is the brand name of the drug sibutramine
which is sold by Abbott Laboratories in Ireland.
The prescription weight-loss drug sibutramine
(Meridia) appears to be highly effective for weight loss, according to a recent clinical study.
, also known as Reductil, should be available on prescription in England and Wales as one part of an overall treatment plan for the obese, the National Institute for Clinical Excellence advised.
is the only appetite suppresant medication approved for longer-term use in significantly obese patients, although the safety and effectiveness have not been established for use beyond one year.