A study funded by Abbott Laboratories offered more detailed evidence that its weight-loss drug Meridia increases heart risks, prompting renewed calls by consumer advocates and others to pull the drug from the market.
Final data from the so-called SCOUT study, published on Wednesday, showed Meridia increases the risk of heart attacks and strokes in patients who already have heart disease. Patients taking the drug lost an average of 8.8 pounds (4 kg).Patients given Meridia had a 16 percent increased risk of heart problems such as heart attack or stroke compared to those given a placebo, the study showed. There was no increased risk of death, although Meridia patients also saw an increase in blood pressure and heart rate, it said.
The findings come two weeks ahead of a U.S. Food and Drug Administration public hearing to discuss whether to take further action against the drug, which is already withdrawn in Europe."When you put those ... things together, you have to wonder if the drug should be on the market any longer," said Dr. Gregory Curfman, executive director of the New England Journal of Medicine, which published the study.
"That's what you're trying to prevent through weight loss. You're trying to prevent people from having heart attacks, and here this drug caused more," said Curfman, a cardiologist.
Preliminary results from Abbott's study were initially disclosed to both U.S. and European health officials in late 2009 and led to Meridia's removal from the European market.At the same time, the FDA strengthened the drug's warning about risks to patients with pre-existing cardiovascular disease and called for a public meeting with its outside advisers.
An FDA advisory panel is to meet on Sept. 15 to discuss the drug.
Not a big seller
Meridia is not a big seller for the Illinois-based drugmaker, but has drawn attention to the controversial area of prescription diet drugs ever since its U.S. approval in 1997. The company expects Meridia's 2010 U.S. sales to be less than $30 million.
The trial looked at 10,744 overweight or obese patients who were at least 55 years old and had either heart disease, diabetes or both conditions. It ran from 2003 to March 2009.Abbott has defended continued use of the drug in the United States, where two out of three people are overweight or obese. The company, along with the study's authors, said Meridia should still be used, just not by people with heart problems.
Abbott spokesman Scott Davies said the company only studied the drug in riskier patients because regulators required it as a condition for approval, and that Meridia already clearly warns heart disease patients against using the drug.
"If you look at all of the data involved, in the approved patient population there is certainly a positive risk-benefit profile," he said. Those who are obese with no heart problems and have not lost weight with diet and exercise are ideal candidates for the drug, also known as sibutramine, he said.
Consumer groups and an FDA whistle-blower have long called on FDA to pull Meridia, in part because so many people have undiagnosed heart disease and are at greater risk.
Public Citizen's Health Research Group Director Sidney Wolfe said the journal's detailed data shows the FDA should have acted long ago. "FDA has unconscionably allowed this drug, which should not have been approved in the first place, to stay on the market," said Wolfe, who petitioned the FDA for Meridia's removal in 2002. "The agency appears immobilized to act against drugs that have no unique benefits but unique, serious dangers.
"The FDA denied his request, in part saying it would await the results from the SCOUT trial. FDA spokeswoman Karen Riley said the FDA advisory panel would review the company's latest analysis, among other information. "There's going to be a lot more data than what's being provided in the journal piece," she added. (Reuters, September 2010)