Following research suggesting that the diet pill Meridia increases the risk of heart attacks and strokes, the federal government will consider pulling the Abbott Laboratories’ drug off the market, The Associated Press reports.
European regulators already have taken that action, withdrawing the product in January.
Meridia, known chemically as sibutramine, has been sold since 1997. But data released in November showed patients with heart disease who took the drug had more heart problems than those who took a placebo. A Food and Drug Administration reviewer who looked at the analysis concluded that using Meridia for an average of 3.5 years increased the risk of major heart problems by 16 percent, according to Reuters.
Another FDA official, Dr. Simone Pinheiro of the agency’s epidemiology division, said in a memo released Monday that, “Given the modest decrease in body weight associated with sibutramine and the potentially substantial weight regain with discontinuation of therapy, even a small increase in cardiovascular risk seems unwarranted.”
However, the FDA said Monday that it is considering a range of options, including simply adding more warning labels. It will take up the issue at a public hearing Wednesday, when it considers assessments from an advisory panel.
An Abbott spokesman said the company expects this year’s global sales of the drug, which never was a blockbuster product, to fall below $100 million, including less than $30 million in the U.S., he said.
In a document posted on the FDA’s website, Abbott says that available data on Meridia “continues to support its effectiveness as a weight loss agent in an appropriate patient population.”
