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Posts Tagged ‘Meridia’

 

Dr. Wolfe

 

The Food and Drug Administration (FDA) approved Meridia in 1997 despite pre-approval randomized trial evidence of significantly increased blood pressure and heart rate (both risk factors for heart attacks) and despite the opposition of the FDA medical officer who reviewed the drug and the FDA’s advisory committee. Our 2002 petition to the FDA to ban the drug was based on this information and a growing number of post-marketing cases of heart attacks with no other explanation in relatively young patients.

Since then, more than 3 million prescriptions have been filled for Meridia, with many patients inevitably having had heart attacks or strokes because of its known toxicity. Even since January of this year (after our December 2009 re-petition to ban the drug), when the European Medicines Agency decided to withdraw the drug from Europe, there have been more than 160,000 prescriptions filled for Meridia in the U.S.

The FDA’s decision today to ask pharmaceutical maker Abbott to withdraw the drug is commendable, but dangerously too late for all of the victims of its unacceptable risks. It appears that it was banned only because of the rare concordance about banning a drug between FDA’s Office of New Drugs (OND) and FDA’s Office of Surveillance and Epidemiology (OSE), as documented in last week’s Oct. 4 memo from those two divisions to Center for Drug Evaluation and Research Director Dr. Janet Woodcock.

In both of the other cases in which drugs have recently been taken off the market in Europe – Darvon (propoxyphene) and Avandia (rosiglitazone) – OSE also urged a ban in this country but was “overruled” because of the reckless unwillingness of OND or Dr. Woodcock to ban the drugs. Thus, both of these unacceptably dangerous drugs remain on the market in this country, predictably injuring or killing many people, who, unlike their European counterparts, do not have the government protecting them from drugs with no unique benefits, but significant, unique risks.

Dr. Sidney Wolfe is the director of Public Citizen’s Health Research Group.

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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 (more…)

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