The results will be reviewed at a meeting of the U.S. Food and Drug Administration next month, when officials will weigh whether the medication should remain on the market. European regulators pulled the drug from pharmacy shelves last year on the basis of a preliminary review of the study. Abbott has said Meridia will generate $100 million this year in worldwide sales.
The findings led public health advocates to ask why it has taken the FDA so long to act on the medication, approved 14 years ago even as evidence showed it can raise blood pressure and heart rate. Patients taking the drug lost an average of 4.3 kilograms (9.4 pounds) during the six-year study.
“Fundamentally, it’s pretty bad,” said Steven Nissen, chief of cardiology at the Cleveland Clinic, in a telephone interview. “Here is a drug that has no medical benefits whatsoever and high risks. The FDA ought to get this drug off the market.”
The findings don’t change the company’s position that Meridia benefits select patients, including those without heart disease who haven’t been able to lose weight with diet and exercise alone, said Scott Davies, an Abbott spokesman. More than 90 percent of patients in the trial wouldn’t be eligible to be given Meridia on the basis of its current marketing label, he said in a telephone interview.
“This is an important option for patients and physicians to treat a serious condition for which there are few treatments currently available,” Davies said.
The drug is expected to generate about $30 million in sales in the U.S. this year, he said.
Calling for the medicine to be banned is “complete madness,” said Philip James, the lead researcher of the study, who is a professor of nutrition at the London School of Hygiene & Tropical Medicine. “The normal prescription requirements should continue, but with a strong warning against using it in people who have had heart attacks or strokes.”
The FDA is also reviewing three new prescription weight- loss drugs this year. Vivus Inc., the Mountain View, California- based company that was first in line, failed to win an advisory panel’s backing of its Qnexa drug in July.
Next FDA Panels
The panel is scheduled to review San Diego-based Arena Pharmaceuticals Inc. and Tokyo-based Eisai Co.’s lorcaserin Sept. 16 and tentatively slated to review La Jolla, California- based Orexigen Therapeutics Inc.’s Contrave Dec. 7. The FDA usually follows the recommendations of its advisers, though it’s not required.
On Sept. 15, doctors and scientists on the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will discuss the results of today’s Meridia study, called Scout. In January, the agency asked Abbott to revise Meridia’s prescribing information to say that it isn’t recommended for people with a history of cardiovascular disease, based on data from the Scout trial.
The study of Meridia, funded by Abbott Park, Illinois-based Abbott, tracked 9,804 high-risk patients with heart disease, diabetes or both to see if the medicine influenced their cardiac health. Previous trials showed weight loss improves health and helps the heart, though none looked at the long-term risks of weight-loss drugs.
After more than three years, 11.4 percent of those given Meridia died or suffered a heart attack, stroke or cardiac arrest, compared with 10 percent given a placebo. The biggest difference was in heart attacks and strokes, particularly in patients who already had heart disease.
“It is difficult to discern a credible rationale for keeping this medication on the market,” wrote Gregory Curfman, Stephen Morrissey and Jeffrey Drazen, the journal’s editors, in a commentary. It “has minimal efficacy for weight loss, no apparent benefit for clinical outcomes, a worrisome cardiovascular risk profile and a plausible mechanism to explain the cardiovascular risk.”
If you look only at patients who lost weight, they did show a benefit, James said. Those results will be presented to the FDA, he said. The researchers were shocked by the decision to pull the drug off the market in Europe on the basis of the study results, and unanimously agree it should remain available in the U.S., James said.
“We wouldn’t hesitate to treat people with Meridia, but we would emphasize that blood pressure should be monitored early on to see if they have an unusual response,” James said. “And of course, you don’t continue treatment if they don’t lose weight.”
Public Citizen filed a request in 2002 with the FDA to pull Meridia off the market. The petition was denied in 2005, and the agency said the findings from today’s Scout study would resolve questions about Meridia’s safety.
“This is a non-brainer,” said Sidney Wolfe, health- research director for the consumer advocacy group in Washington. “There is no evidence of any benefit. There were some groups that weren’t harmed, but that’s not good enough. It should have never been on the market and it’s long overdue to come off the market.”