Tag Archives: diet pills

US health watchdog refuses to OK new diet pill

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Lorcaserin [320x200].jpg The US’s Food & Drug Administration has refused permission for the manufacturers of Lorcaserin, a new diet pill, to put it on the market.

The FDA told Arena Pharmaceuticals this was because of concerns about its marginal effectiveness and about cancers that occurred at higher-than-usual rates during clinical trials with rats. The FDA’s decision comes just two weeks after the makers of the prescription diet-pill Meridia was banned in the US and Canadian markets at the request of the FDA.

Lorcaserin was developed by Arena Pharmaceuticals, the San Diego drug company in partnership with Eisai Co.

Among the FDA’s concerns were weight-loss results that failed to rise to the FDA’s standards for approval, and an  increase in cancerous breast and brain tumors in rats that were given a dose of the drug that is higher than that proposed for humans.

A clinical trial of Lorcaserin published in the New England Journal of Medicine found that two-thirds of patients lost at least 5% of their body weight, while a third lost at least 10% of body weight, with an average loss of 17 to 18 pounds.

US diet pill ban over heart attack and stroke risk?

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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.

Merediabig [320x200].jpg

 
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: Risks vs. Benefits

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.

Conflicting Viewpoints

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.