Sibutramine: uses, side effects and safety

Important note

DISCONTINUED. Meridia (sibutramine) was approved by the FDA on November 22, 1997 (NDA020632) and was voluntarily withdrawn from the U.S. market on December 21, 2010. FDA's recommendation was based on new data from the Sibutramine Cardiovascular Outcomes (SCOUT) trial, which demonstrated a 16% increase in risk of major adverse cardiovascular events in patients treated with Meridia compared to placebo, and only a small amount of body weight lost versus placebo at 60 months (approximately 2.5% difference in mean percent change in body weight). FDA concluded the risk of an adverse cardiovascular event in the population studied outweighed any benefit from the modest weight loss observed. Sources: FDA Drug Safety Communication, 'FDA Recommends Against the Continued Use of Meridia (sibutramine)' (October 8, 2010), https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications-fda-recommends-against-continued-use-meridia-sibutramine ; and FDA Warning Letter to Je Dois Lavoir LLC (August 11, 2021), which states the drug was 'withdrawn from the United States market on December 21, 2010 after clinical data indicated sibutramine poses an increased risk of heart attack and stroke', https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/je-dois-lavoir-llc-616016-08112021 . No current DailyMed label exists: drug_name=sibutramine returned zero SPLs, and a drug_name=Meridia search returned only unrelated Bob Barker 'Meridian' fluoride toothpaste products. Therefore medlinePlusId and dailymedSetid are null, metabolism, halfLife, onsetHours and peakHours are null, and commonSideEffects and keyInteractions are empty arrays - none of these could be verified from a current label within the permitted primary sources. strengths are taken from the last FDA-approved Meridia label (020632s026), https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020632s026lbl.pdf . Note sibutramine remains a Schedule IV controlled substance under 21 CFR 1308.14(f)(12) even though its approval was withdrawn.