Abbott Tosses Out Meridia, Cardio Risks are Too Heavy

Sorry I can't link the original- from paid subscription....

WASHINGTON – Less than a month after an FDA advisory panel was evenly split over whether to permit Abbott to continue marketing its prescription weight loss drug Meridia (sibutramine), which had been linked to a higher risk of heart attacks and strokes, the company Friday voluntarily yanked the drug from the U.S., Canadian and Australian markets.

Sales of Meridia and other sibutramine-containing products already had been suspended in Europe in January.

The FDA Friday also warned consumers not to take a sibutramine-containing product called Slimming Beauty Bitter Orange.

John Jenkins, director of the FDA's Office of New Drugs, noted that his agency requested the withdrawal of Meridia after concluding that the continued availability of the product "is not justified, since patients who take the drug are at an increased risk of heart attack or stroke, and on average, achieved only modest weight loss."

The FDA Friday told doctors and pharmacists to cease all prescribing and dispensing of Meridia and advised patients to stop taking the drug and dispose of any remaining pills.

Meridia was approved by the FDA in November 1997 to help obese and overweight patients with underlying cardiovascular risk factors lose weight.

At the time of the approval, the clinical evidence for Meridia showed that about twice as many patients who took the drug managed to lose at least 5 percent of their body weight, compared with those who took a placebo, Jenkins told reporters Friday. Safety concerns at the time of Meridia's approval included increases in heart rate and blood pressure, he noted.

"Given the expected benefit associated with weight loss, and the fact that these adverse effects could be monitored and the drug stopped in patients who experienced sustained increases in heart rate and blood pressure, FDA concluded that the benefits of the drug outweighed its potential risks," Jenkins said.

But a recently completed analysis by the FDA of a large cardiovascular outcomes trial, known as SCOUT, showed that patients treated with Meridia did not achieve the expected cardiovascular benefit from losing weight, and instead, experienced a 16 percent higher rate of adverse cardiovascular events, such as heart attacks and strokes, compared with patients who took placebo, Jenkins said.

In fact, Meridia patients in SCOUT lost only an average of about 2.5 percent more weight than patients treated with placebo. Jenkins pointed out that SCOUT was conducted to meet a postmarketing requirement by European drug regulators, and most of the Meridia-treated patients in the study "would not have been appropriate candidates for the drug, according to the current FDA-approved label's warnings and precautions."

He noted that regulators had presented SCOUT's results at a Sept. 15 meeting of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee, at which half of the panelists recommended Meridia be withdrawn from the market, while the other half advised either imposing restrictions on the distribution of the drug or increased warnings. "FDA carefully considered the advice from the committee experts, and determined that there was no identifiable population of patients in whom the benefits of Meridia outweighed its risks," Jenkins said.

When regulators confront a significant safety issue involving a drug, "we carefully consider whether there might be a group of patients for whom the benefits of the drug still outweigh the risks," said Gerald Dal Pan, director of the FDA's Office of Surveillance and Epidemiology.

If the agency finds such a population, it may consider a risk evaluation and mitigation strategy, which could be constructed to limit access to a narrow patient group, he said.

But in the case of Meridia, the FDA found no safe population for the product and reached a "consensus decision" that the drug should be withdrawn, Dal Pan said.