The US watchdog, the Food and Drug Administration, has yet to decide whether diet pill, Meridia, should stay on the market after a report revealed that it may cause heart attack and strokes in some individuals.
Meridia, also known as sibutramine, was first approved in the US in 1997, but a large study released last November shows that people who took the drug had an 11% risk of cardiovascular events, while those who took a placebo had a 10% risk.
The study, called the SCOUT trial, prompted regulators to order the drug off the market in Europe. And demands for it be banned in the US are now being made.
Meridia has been shown to reduce weight in many patients – on average 4% more body weight below what they might lose with a placebo, an amount considered a modest benefit. About one-fifth of patients lose more. But the drug also causes increases in heart rate and blood pressure, both of which pose a danger to patients with cardiovascular disease.
Patients with known cardiovascular disease are not meant to be prescribed teh drug. But experts said they were troubled that many patients with undiagnosed disease could be at greater risk if they use the drug to lose weight.
The FDA’s own monitoring linked 14 deaths to the use of Meridia.The patients who died were in their 40s 71% were women.
The Public Citizen Health Research Group,in the US, which first petitioned FDA to ban Meridia in 2002, says the drug poses a “deadly tradeoff” between modest weight loss and the danger of heart attack and stroke.
Others say Meridia can be made safe by closely monitoring things like patients’ pulses and blood pressure readings.
Abbott, which manufactures Meridia, had pledged step up warnings and educational efforts for doctors and patients if the drug is allowed to stay on the market.
Meridia’s popularity has plummeted in recent years, particularly since the release of the Scout trial’s data in November. Only an estimated 280,000 prescriptions were filled last year in the US.
The FDA now has to decide if the clear benefits of even modest weight loss to most patients is worth a rise in cardiovascular risk in some of them. The FDA will also likely consider what vital signs doctors should monitor, and how often they should monitor them, to minimize the drug’s risks.