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FDA should ban weight-loss drug linked to deaths

Four years ago, the Food and Drug Administration rejected Public Citizen’s petition to ban the weight-loss pill Meridia. At the time, the FDA said it wanted to wait to see the results of an ongoing trial. Well, those results are in and they show that Public Citizen’s concerns about Abbott Laboratories’ Meridia were well founded. Research from a 10,000-patient study shows that the popular weight-loss drug has caused a significantly increased number of heart attacks, strokes, resuscitated cardiac arrests and deaths in obese patients.

So, here we go again. Public Citizen filed another petition today asking the FDA for an immediate ban of Meridia. Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said the pressure is on the FDA to do the right thing:

If the FDA truly intends to operate as a public health agency, then it should acknowledge that the continued approval of this drug cannot be justified based on science. The FDA should therefore tell Abbott to pull Meridia from the market immediately.

When Public Citizen filed its first petition in 2002, it based its request on results of pre-approval clinical trials that showed obese patients on the drug experienced increases in blood pressure, pulse rate and palpitations. Now, there’s even more evidence against the use of Meridia. From the Associated Press story:

Public Citizen said there had been a total of 84 deaths associated with Meridia reported to FDA as of June this year.

FDA approved Meridia in 1997 as a weight loss aid alongside diet and exercise. The drug is related to the amphetamine family of stimulants.

Public Citizen pointed out that the agency’s panel of outside specialists voted 5 to 4 that the drug’s risks outweighed its benefits. The agency isn’t required to follow their advice, though it often does.