Diet Drug Danger: Meridia Raises Cardiovascular Risk

abc ^ | Sept. 15, 2010 | Courtney Hutchinson

[facedodge]

New Safety Concerns May Lead FDA to Recommend Pulling Abbott Lab Drug

Diet pill Meridia may garner new warning labels or be pulled from the market completely following today's meeting of the Food and Drug Administration's drug advisory committee.

Spurred by concern that Meridia might increase cardiovascular risk, Abbott Laboratories, which makes the drug, had sponsored a six-year trial, SCOUT, to further evaluate its safety.

Now that results are in, a group of outside advisers to the FDA will meet today to weigh whether the 16 percent increased risk in major adverse cardiac events seen in the trial is reason enough to restrict access or withdraw the drug from the U.S. market.

Related 11 Medical Weight Loss Treatments ExaminedWATCH: What Is Meridia, How Does it Work?New Diet Pill Safe and Effective ... So FarGiven that patients on Meridia only lost five pounds more in the study than those on placebo, many doctors feel that this increased cardiovascular risk is simply not worth it.

"The key point here is that obesity itself is associated with increased risk of cardiovascular disease, so the rationale for prescribing obesity drugs is to improve outcomes [by lowering that risk]," says Dr. Kevin Niswender, assistant professor of medicine at the Vanderbilt University School of Medicine.

"A drug that is modestly successful at increasing weight loss but increases cardiac risk further, that's clearly an issue," he said.

Abbot Laboratories products containing Meridia's main ingredient, Sibutramine, were already pulled from the European market in January based on preliminary results from SCOUT.

[facedodge]

They might as well pull the drug, Moochelle Obama has got that whole "fat people thing" under control.

[fireforeffect]

Eat less, exercise more.

Works every time.

[HangnJudge]

The FDA is just now catching on?

http://www.cmaj.ca/cgi/content/full/166/10/1307

sibutramine has been taken off the market in Italy after 50 adverse events (primarily tachycardia, hypertension and arrhythmias) and 2 deaths from cardiovascular causes were reported in that country.

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2003/2003_07-eng.php

On March 27, 2002, Health Canada issued a public health advisory informing Canadians that it was conducting a review of the safety profile of the marketed drug in light of international regulatory action and adverse reactions reported in Canada and elsewhere. Last year’s advisory explained that Italian authorities had temporarily suspended market authorisation of all drugs containing sibutramine in that country, primarily because of concerns regarding cardiovascular events and two deaths.