Meridia
Death & Side Effects
Public Citizen consumer group is very proactive in promoting
safe and effective prescription drugs. On March 19, 2002,
Public Citizen petitioned the FDA for the immediate ban of
Meridia because the "risks
of heart problems far outweigh benefits". After being
introduced to the U.S. market in 1998, the diet pill has been
associated with 29 Meridia deaths and hundreds of serious
Meridia side effects. Public Citizen stated the FDA knew before
approving Meridia of the ability for the diet pill to cause
side effects increasing blood pressure and heart rate in addition
to delivering minimal results.
Italy was the first country to take action against Meridia,
banning the diet pill from the market in March after two Meridia
deaths. The Italian government's action prompted a Europe-wide
review of the safety of Meridia, and Canada has also stated
they are investigating Meridia's safety implications and side
effects. In France and the United Kingdom there have been
over 100 serious adverse side effects reported and two Meridia
deaths. Public Citizen questions why Meridia was ever FDA
approved one year after their own advisory committee voted
5-4 that the benefits of the drug did not outweigh the risks
of Meridia side effects. The FDA medical officer  that
reviewed Meridia did not support approving the diet pill because
of research showing the potential side effects of heart problems.
The petition to ban Meridia is Public Citizen's fifth petition
to ban a drug since 1996, including the 1997 banned diet drug
Redux. In addition to the previous four drugs, Meridia has
had evidence of serious risks and side effects prior to FDA
approval. Public Citizen concluded in their petition that
"sibutramine (Meridia) is a drug that should never have
been approved, and in the interest of the safety of the American
public it must come off the market now."
On May 21, 2002, Public Citizen sent a letter calling for
criminal charges against Abbott Laboratories in regards to
their actions concerning Meridia diet pill. The letter was
sent to Health and Human Services Secretary Tommy Thompson
because of Abbott's actions of illegally withholding important
information from the FDA about 8 Meridia deaths and other
adverse Meridia side effects. An FDA inspection report of
the Abbott Laboratories plant from 3/21-4/3/02 found one Meridia
death was not reported and that several records that concerned
seven other Meridia deaths were "not accurate, not supported
by source data, or was missing additional information found
in the source data".
In addition, Public Citizen also found grounds for criminal
prosecution of Abbott in the review of the FDA's adverse event
reporting system-computerized database of three cases. Abbott
failed to notify the FDA of an adverse Meridia
side effect within the 15 days after the company becomes
aware of it that is required by law, including one Meridia
death. After the reported 29 Meridia deaths Abbott denied
there was any evidence that Meridia was responsible for the
deaths and attributed the fatalities to the higher risk of
cardiovascular death that obese people have. Abbott's actions
of not readily revealing and reporting recent Meridia side
effects and Meridia deaths has led Public Citizen to conclude
that they may be trying to conceal important information linking
Meridia to the resulting deaths.
The U.S. government has responded to Public Citizen's actions
by saying they will thoroughly investigate the Meridia deaths
and reevaluate whether or not Meridia provides enough benefits
to remain on the market. If you have questions regarding your
legal rights with Meridia side effects, please contact
us to speak with an expert Meridia lawyer.
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