The Food and Drug Administration announced last Friday that the diet drug Meridia is being taken off the market. This follows literally years of complaints that Meridia increases the risks of heart attacks and strokes for those people taking the drug.
Robert Langreth, in his blog at Forbes.com, presents an excellent viewpoint of the changes in the Food and Drug Administration in recent months. Here are excerpts:
The FDA finally recalled Abbott Laboratories’ obesity drug Meridia today. The nail-in-the-coffin was a big new study showing that the drug can increase heart attacks and strokes in high-risk patients.
But the potential for harm was obvious from day one. From the beginning it was clear the drug raised blood pressure and heart rate. Given this effect, it was always hard to imagine how the drug would have a net benefit to patients. Way back in 1996, an advisory panel agreed that the blood pressure rise produced by the drug was clinically important. Public Citizen has been petitioning to get the drug off the market since 2002 based on the potential for heart harm.
But back in the good-old-days (for the drug industry) in the mid-1990s, the FDA was far less stringent about safety of obesity drugs that may be used by millions. The fen-phen diet drug disaster hadn’t happened yet. The FDA approved the drug and kept it on the market for a long time, despite a very modest weight loss benefit and obvious problems with the safety of the drug. Only now that conclusive evidence is in does the drug get recalled.
The real story here is the changing regulatory environment. In the wake of Merck’s Vioxx scandal and GlaxoSmithkline’s Avandia mess, a drug like Meridia can no longer slip through the cracks. No longer will the FDA approve a drug for the masses based on a small symptomatic benefit or mild improvement in a lab value if a medicine isn’t demonstrated to have tangible improvements on patient health down the road. Approving a drug on a hunch it will help people won’t cut it anymore.
Here is the official announcement from the FDA:
Abbott Laboratories agrees to withdraw its obesity drug Meridia
Abbott Laboratories has agreed to voluntarily withdraw its obesity drug Meridia (sibutramine) from the U.S. market because of clinical trial data indicating an increased risk of heart attack and stroke, the U.S. Food and Drug Administration announced today.
“Meridia’s continued availability is not justified when you compare the very modest weight loss that people achieve on this drug to their risk of heart attack or stroke,” said John Jenkins, M.D., director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research (CDER). “Physicians are advised to stop prescribing Meridia to their patients and patients should stop taking this medication. Patients should talk to their health care provider about alternative weight loss and weight loss maintenance programs.”
Meridia was approved by the FDA in November 1997 for weight loss and maintenance of weight loss in obese people, as well as in certain overweight people with other risks for heart disease. The approval was based on clinical data showing that more people receiving sibutramine lost at least 5 percent of their body weight than people on placebo who relied on diet and exercise alone.
The FDA requested the market withdrawal after reviewing data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT). SCOUT was initiated as part of a postmarket requirement to look at cardiovascular safety of sibutramine after the European approval of this drug. The trial demonstrated a 16 percent increase in the risk of serious heart events, including non-fatal heart attack, non-fatal stroke, the need to be resuscitated once the heart stopped, and death, in a group of patients given sibutramine compared to another given placebo. There was a small difference in weight loss between the placebo group and the group that received sibutramine.
“The patients in the European SCOUT trial did not have the same characteristics as the patients for the approved indication in the United States; however, these results, combined with other available safety data raised serious questions about Meridia’s safety for all patient groups,” said Gerald Dal Pan, M.D., M.H.S., director of the Office of Surveillance and Epidemiology in CDER.
The agency’s analysis of SCOUT was the subject of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee meeting on Sept. 15.
