People hoping for a safe way to lose weight by taking a pill will have to wait a little longer.
Almost 12 years ago to the month, I remember reviewing the clinical trial data on the efficacy and safety of the just-approved prescription weight loss drug sibutramine (Meridia). At that time, many in the medical community had fairly high hopes for this drug, given that there were so few approved medications to help overweight and obese people—and especially given the ever increasing population of overweight adults. But many were also quite aware of the risks that these medications posed—especially the potential risks associated with increasing one's heart rate and blood pressure (which were likely already elevated) in people who were the ultimate target group.
In the previous year (1997), the Food and Drug Administration had actually removed from the market two popular weight loss drugs: dexfenfluramine (Redux) and fenfluramine (Pondimin) due to specific heart risks associated with their use.
Back then, we just weren't all that impressed by how little weight people actually lost with Meridia during the relatively short trials, compared to those folks who received a placebo (sugar pill). Those who took Meridia also experienced some clear increases in heart rate and blood pressure. So, we reported in November 1998 that we felt Meridia was not worth the risk and we titled our brief article that appeared in Consumer Reports on Health "Meridia: Not safe for slimming."
On September 15th, an advisory committee to the Food and Drug Administration will convene to address the results of the SCOUT study and determine the future of this drug's availability to the public. What was stated in the last paragraph of the editorial that accompanied the NEJM study sums up our feeling on this issue best:
"The FDA advisory committee will now take up the matter. We surely need safe and effective medications to help overweight and obese patients lose weight and improve their long-term health. But given that sibutramine 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, it is difficult to discern a credible rationale for keeping this medication on the market."
—Chris Hendel, Associate Director, Health & Family












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