How long does it take to get a dangerous drug off the market? The weight-loss drug Meridia provides the latest test case. At the end of last year, the Food and Drug Administration (FDA) announced that it was looking into an early finding from a large international trial. Here’s the bad news that emerged from the trial last November: There were more heart attacks, strokes, and deaths among obese people with heart problems taking Meridia than those taking a placebo. Ironically, this trial was designed specifically to prove Meridia will not just help people lose weight, but it would also spare them the heart problems associated with obesity.

Last week, drug regulators in Europe and the U.S. reacted. The European Medicines Agency took a strong stance, advising doctors and pharmacists to stop prescribing and dispensing the European equivalents of Meridia. Obviously, the EMA thought the drug’s risks outweighed its benefit. And what did the FDA do? It took the wimpy route, asking Abbott Laboratories, maker of Meridia, to put a stronger warning on Meridia label. This is one notch better than doing nothing. Unfortunately hardly anyone, including most doctors, reads the drug label that can be 20-40 pages long. (Click here to see why.) Keep in mind that both regulatory agencies were looking at the same data from the same trial.

Known as the SCOUT trial, this large study was testing the widely held assumption that weight loss itself would automatically reduce the risk of heart problems in people who are overweight and obese. It included 10,000 overweight or obese people, aged 55 or older, who had heart disease or diabetes, or both. They were randomly assigned to take Meridia or a placebo for six years. All had been advised to make the same lifestyle changes associated with weight loss. The SCOUT trial found 1.4% greater risk of heart attack, stroke and death (combined) in the participants taking Meridia, according to the FDA’s June 30, 2009 Web site notice.

FDA watchdog Sidney Wolfe, MD, Director of the Public Citizen’s Health Research Group, assessed the Meridia-related cases on the FDA’s database for adverse reactions reports, while noting the underreporting common to all drugs. “We have found that there are now, as of June, 2009, a total of 84 reports of deaths from cardiovascular causes in the FDA Adverse Event Reactions database, including 30 in people 50 or younger. Of these 30 people, 11 were 30 or younger. It must be noted that FDA’s own estimates are that no more than one in ten adverse reactions to drugs that occur are reported to the agency,” wrote Dr. Wolfe in a December 3, 2009 letter to the FDA commissioner.

Dr. Wolfe initially petitioned the FDA to ban Meridia in 2002 because the placebo-controlled trials conducted prior to its approval showed that the drug caused increases in blood pressure, pulse rate, and palpitations.

For more information

About Dr. Wolfe’s Health Research Group, here’s its Web address.

About the FDA’s position, read its January 21, 2010 alert aimed at physicians and patients.

Maryann Napoli, Center for Medical Consumers(c)