October 13, 2010 – Last week, Abbott Laboratories recalled their weight loss drug Meridia® after nearly fifteen years on the market. The decision came after an FDA study revealed that the medication was strongly associated with various heart problems in patients. Now those affected are beginning to seek legal action against the company.
Meridia SCOUT Study
According to Abbott, the FDA’s request for the company to remove Meridia from the US market is based mainly on the results of the SCOUT (Sibutramine Cardiovascular OUTcome Trial) study. The study researched approximately 10,000 patients over 6 years, and was requested by European regulatory authorities as a post-marketing commitment to evaluate cardiovascular safety in high-risk patients.
SCOUT showed that the average difference in body weight between people on Meridia and those on a placebo was about 2.5%, yet there was a 16% increase in the risk of heart attacks and strokes. This apparent risk-to-benefit ratio was not acceptable to the FDA, prompting a request to Abbot that they should recall Merida.