For Immediate Release
New Evidence of Dangers Associated With Weight-Loss Drug Meridia Makes an Immediate FDA Ban Imperative
For the Second Time This Decade, Public Citizen Petitions FDA to Ban Meridia
caused a significantly increased number of heart attacks, strokes,
resuscitated cardiac arrests or deaths in obese patients getting the
drug and should be pulled from the market immediately, Public Citizen
said today in a petition to the Food and Drug Administration (FDA).
This is Public Citizen's second petition to have Meridia banned; the
FDA rejected the first four years ago, saying it was awaiting results
of an ongoing trial. The results are in, and they show that the drug's
dangers significantly outweigh its benefits.
"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," said Dr. Sidney Wolfe, director of
Public Citizen's Health Research Group. "The FDA should therefore tell
Abbott to pull Meridia from the market immediately."
Public Citizen first petitioned the FDA to ban sibutramine, the
active ingredient in Meridia, on March 19, 2002. The organization based
its request on results of pre-approval clinical trials that
demonstrated increases in blood pressure, pulse rate and palpitations
in obese patients taking the drug.
Despite scientific evidence that these patients were three times
more likely to experience clinically significant electrocardiogram
changes than obese patients taking placebos - coupled with the minimal
benefit of an average six-and-a-half pound weight-loss difference
between the two groups - the FDA approved the drug in 1997. By March
2003, there were reports to the FDA's adverse reaction system of 49
cardiovascular deaths among patients taking Meridia. Twenty-seven of
the 49 (55 percent) were in people younger than 50 years old. The
number is likely higher, as the FDA estimates that only one in 10
adverse reactions to drugs are reported to the agency.
In responding to Public Citizen's 2002 petition, the FDA said that
until a large, randomized study could provide more conclusive results,
Meridia would continue to be sold. Now the early results are in from a
persuasive study called SCOUT, in which 10,000 people across Europe
participated. The recently released results of this study reveal a
significant increase in heart attacks, strokes, resuscitated cardiac
arrests or deaths in obese patients 55 or older with known or
undetected cardiovascular disease who used sibutramine, compared with
those given a placebo. Both groups were on the same weight management
Based on the new findings from the SCOUT study and Public Citizen's
updated figures based on an analysis of FDA data, Public Citizen
calculates that there have been 84 post-approval cardiovascular deaths
of patients taking Meridia. This includes 32 patients who were 50 or
younger and 11 patients 30 or younger. Public Citizen urges the FDA to
take immediate action to ban sibutramine. About 294,000 prescriptions
for Meridia were filled in the past 12 months.
READ Public Citizen's petition.
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