A few years after it hit the market, the diet drug Meridia was being investigated by health authorities globally for links to more than two dozen deaths and hundreds of adverse reactions. But those authorities, including Health Canada, concluded that Meridia, the brand name of the drug sibutramine, was safe enough to remain on the market and be prescribed to treat obesity.
Seven years later, Abbott Laboratories, the company that sells Meridia, has voluntarily pulled it off the market in Canada and the U.S. after a major study published last month, funded by the company, found that it raises a patient’s risk of stroke, heart attack and cardiovascular death.
Two generic versions, called Apo-sibutramine and Nova-sibutramine, have also been pulled off Canadian shelves.
The study, which last more than three years, also found that patients lost, on average, less than 10 pounds on sibutramine, which acts on the serotonin system to make an individual feel full.
Abbott Laboratories stands by Meridia, maintaining that the benefits outweigh the risks as long as the appetite suppressant is given to people without pre-existing cardiovascular disease and patients are monitored closely for increased blood pressure or pulse rate.
However, some medical experts and advocates see Meridia as an example of deep-rooted problems in the drug-safety system that urgently need to be fixed. There is concern that such health issues could arise again, as other companies look to create new appetite-suppressing prescription drugs.
“I think it took a decade or more to establish that sibutramine is really not a safe enough compound, and that’s too long,” said Gregory Curfman, executive editor at the New England Journal of Medicine, who co-wrote an editorial in September calling for the drug’s removal.
Meridia was approved for use in Canada in 2000, while it has been sold in the U.S. since 1997.
In 2005, nearly 90,000 prescriptions for Meridia were dispensed from retail pharmacies in Canada, according to IMS Brogan, a company that tracks the pharmaceutical industry. Last year, nearly 120,000 prescriptions for Meridia were dispensed.
Health Canada, which received 259 reports of adverse reactions linked to sibutramine, says consumers were well informed of the potential risks and were warned not to take it if they had heart problems.
Safety concerns dogged the drug for years, as reports of patient deaths and severe adverse reactions emerged around the world, prompting Abbott to launch the clinical trial to evaluate Meridia’s safety.
Scott Davies, an Abbott spokesman, defended Meridia, pointing out that many patients in the trial had pre-existing heart problems, something the drug label warns about.
That argument highlights inherent problems in the market for obesity drugs, said Stephen Morrissey, managing editor of the New England Journal of Medicine. It is easy for doctors to miss heart problems in people who do not have symptoms, meaning that it is highly possible sibutramine could be prescribed to high-risk patients.
Dr. Curfman added that most obese people are already at risk for heart problems; putting them on a drug known to raise blood pressure and heart rate could lead to serious complications. “Any cardiologist will tell you, over time, sustained increases in heart rate and blood pressure are not good,” he said.
He said the clinical trial should have been conducted much sooner because it would have prevented patients from being exposed to a potentially dangerous drug. Companies should be required to conduct such trials early in a drug’s life, he said.
Meridia is not the first diet drug to be linked to serious health problems, and it may not be the last. Two other appetite-suppressing drugs, sold under the brand names Redux, Ponderal and Pondimin, were pulled off the market the same year Meridia was approved for that reason.
Now, Arena Pharmaceuticals is trying to get approval for lorcaserin, a new appetite-suppressing drug that Dr. Curfman and Dr. Morrissey say works in a similar manner to Meridia, Redux, Ponderal and Pondimin.
Last month, a panel of the U.S. Food and Drug Administration recommended against approving lorcaserin, but as companies work toward finding a pharmaceutical solution to the continent’s obesity crisis, there are fears that new appetite suppressants will get approved and expose millions to potentially life-threatening side effects.
Science simply has not identified an effective weight-loss treatment that does not come with serious side effects, Dr. Curfman said. It is a complicated puzzle and until it is figured out, patients should not be exposed to those drugs, he said.
“We’re not against diet pills. It’s just that this is a tough problem,” he said. “It’s been very difficult to come up with diet pills that have an acceptable risk profile.”
