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FDA considers pulling Meridia (sibutramine) off the market
Monday, September 13, 2010 9:04 am Email this article
The US Food and Drug Administration is considering pulling the diet drug Meridia (sibutramine) off the market because of an increased risk of heart attack and strokes notes a story from the Associated Press.
"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," states Dr. Simone Pinheiro, of the FDA's epidemiology division.
Earlier this month, the editors of the New England Journal of Medicine said that FDA should pull the drug off the market.
European regulators pulled the product off the market in January. Meridia increases cardiovascular events in people with a history of cardiovascular disease
Meridia increases cardiovascular events by 27.4% in people with a history of cardiovascular disease
In January 2010, the FDA revealed that Meridia increased the risk of cardiovascular events by 27.4% in people with a history of cardiovascular disease. (See here.
Deaths Reported in Young People
Deaths Reported in Young People with No History of Heart Problems
Another FDA reviewer notes that deaths continue to be reported with the drug in young patients with no history of heart problems notes the AP story.
“Young people without known risk factors, aside from obesity, have died shortly after initiating sibutramine therapy,” states the review from the FDA’s office of surveillance, which monitors adverse events reported with drugs.
Meridia Use Has Declines
Meridia Use is about half of what it was in 2005
Meridia use has fallen nearly in half from what it was in 2005 to about 283,000 prescriptions last year according to prescription data firm IMS Health notes the AP story.
Meridia sales $100 million worldwide, $30 million in the US
Sales of Meridia are expected to be $100 million worldwide this year, including less than $30 million in the U.S.
Meridia should not be used by anyone with a history of heart problems
The FDA notes that Meridia (sibutramine) should not to be used in patients with a history of cardiovascular disease, including:
- History of coronary artery disease (e.g., heart attack, angina)
- History of stroke or transient ischemic attack (TIA)
- History of heart arrhythmias
- History of congestive heart failure
- History of peripheral arterial disease
- Uncontrolled hypertension (e.g., > 145/90 mmHg)
Briefing Document by the makers of Meridia
Briefing Document by the makers of Meridia is posted on-line
A 205-page briefing document prepared by Abbott, the makers of Meridia, is posted here.
Perrone M. FDA mulls pulling diet pill linked to heart attack. Assocaited Press. 2010 Sept 13.
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