Posts Tagged ‘sibutramine’

October 8th, 2010

Abbott Withdraws Sibutramine from U.S. Market

Abbott has pulled its weight-loss drug sibutramine (Meridia) from the U.S. market. A safety communication from the FDA said the “drug may pose unnecessary cardiovascular risks to patients.” Earlier this year the drug was withdrawn in Europe. Sibutramine was approved by the FDA in 1997. The FDA recommendation is based upon a recent analysis of data […]

September 15th, 2010

FDA: Ticagrelor Deadline Extended; No Clear Signal on Sibutramine

FDA watchers require patience. AstraZeneca announced that the FDA had extended its review of ticagrelor (Brilinta) until December 16. The previous deadline had been September 16. In July, the FDA Cardiovascular and Renal Advisory Committee voted 7-1 in favor of approving ticagrelor for the indication of STEMI and NSTEMI patients, but the committee and the FDA […]

September 1st, 2010

NEJM Editors Call for Removal of Sibutramine from U.S. Market

Earlier this year, following the discovery of signals of potential danger in a large clinical trial, the weight loss drug sibutramine (Meridia) was withdrawn from the market in Europe while the FDA added a strongly worded contraindication to its use in people with cardiovascular disease. Now, 2 weeks before an FDA advisory panel will vote […]