Abbott Labs has recalled the obesity drug Meridia in the US for causing an increased risk of stroke and heart attack. From the Pharma Letter:
“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% 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)….The trial demonstrated a 16% 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….the FDA has not approved a new prescription drug for long-term weight loss since Swiss drug major Roche’s Xenical (orlistat) in 1999.
Forbes’ Robert Langreth writes that the Meridia recall is evidence that the FDA has changed over the years:
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.
Translation: The FDA is actually doing its job. This can only be good news.