Abbott Removes Weight Loss Pill Meridia Due to Heart Risk - FDA

Per the FDA website, the Food and Drug Administration relayed on Oct 8 that it has requested Abbott laboratories to withdraw its obesity drug Meridia, or sibutramine, because of its association with an increased risk of heart disease and stroke. 

Abbott Laboratories has agreed to withdraw Meridia from the market, the FDA said. According to the Wall Street Journal, the drug company complied with the request reluctantly, because they said numerous studies have not shown an association between the drug and increased risk of cardiovascular disease. 

What triggered the FDA's request is the Sibutramine Cardiovascular Outcome Trial or simply SCOUT, which shows that patients receiving Meridia were 16 percent more likely to suffer serious heart events, including non-fatal heart attack, non-fatal stroke, the need to be resuscitated once the heart stopped and death over those who received a placebo.  The study also shows that the difference in weight loss in both groups was tiny. 

The SCOUT study was conducted by James W. and colleagues from London School of Hygiene and Tropical Medicine in London, England and published in the Sep 2, 2010 issue of New England Journal of Medicine. 

The study involved 10,744 overweight or obese people ages 55 years of age or older with preexisting cardiovascular disease, type 2 diabetes mellitus or both.  All participants were initially given sibutramine, in addition to a weight-management program for a 6-week period; subsequently, 4906 were given sibutramine and 4898 were not for about 3.4 years. 

The average weight loss was 2.6 kg during the initial period. Additional loss of 1.7 kg of body weight was observed in those who continued taking Meridia during the 3.4 years of follow-up. 

The primary outcome including nonfatal myocardial infarction, nonfatal stroke, resuscitation after cardiac arrest, or cardiovascular death was 11.4 percent in the Meridia group, compared to 10.0 percent. 

Non-fatal myocardial infarction and nonfatal stroke were 4.1 percent and 2.6 percent in sibutramine group compared to 3.2 percent and 1.9 percent in the control group, respectively. 

Nevertheless, the obesity drug did not seem to increase risk in cardiovascular death and death from any cause, according to the study report.  This does not seem in agreement with the FDA statement. 

The FDA approved Meridia in Nov 1997 for weight loss and maintenance of weight loss in obese individuals as well as in certain overweight people with other risk parameters for heart disease. The approval was based on clinical studies showing that people who were on Meridia lost 5 more percent of their weight than those who did not take the drug. 

"Meridia's continued availability is not justified when you compare the very modest weight loss that people achieve on this drug to their risk of heart attack or stroke," said John Jenkins, M.D., director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research (CDER). 

Dr. Jenkins said physicians are required to stop prescribing Meridia to their patients; additionally, patients are advised to stop taking the drug due to said heart risk. 

There are many fad diets available that have been claimed to be effective in helping weight loss. But the long-term efficacy and safety are not clear.   

Dr. Colin T Campbell, a distinguished nutrition professor suggests that a plant-based diet is critical in maintaining a healthy body weight.  He said the Chinese people in rural areas consumed more calories than their American counterparts, but much fewer are overweight or obese. 

Recent studies have linked sugary beverages or sodas with increased risk of obesity. Fructose used in drinks and processed foods is blamed for the obesity epidemic. 

With Meridia removed from the market, another obesity drug, Alli, made by GlaxoSmithKline still remains on the market, even though some consumer advocates suggest the drug needs to be removed from over-the-counter shelves because it is ineffective in eliciting weight loss.

David Liu and editing by Rachel Stockton