Public Citizen petitions FDA for recall, March 19, 2002
Public Citizen calls for criminal charges May 21, 2002.
A habit-forming drug, sibutramine appears to be responsible for deaths in
the US.
View slides from Audio
Conference aired on June 20, 2002
Public Citizen alleges cover-up by Abbott Laboratories / Knoll on Meridia
death. Prescription drug information on diet drug Meridia side effects, dangers,
and adverse reactions updated at FDA a sign of impending drug recall? Diet
drug dangers and prescription drugs side effects plague the important medical
area of obesity.
Drug names
Meridia, sibutramine (Europe: Reductil)
Medical usage
Diet aid
Meridia Adverse effects
Sympathetic activation (increased blood pressure, tachycardia)
Company
Abbott - Knoll - BASF
Meridia Patient presentation
Central and peripheral consequences of inhibition of serotonin, dopamine,
and/or norepinephrine uptake, including cardiovascular accidents
Meridia Litigation status
Major litigation led by Tobi Millrood, Esq.
Approved 22-NOV-97, sibutramine is a non-selective inhibitor of uptake of
biogenic amines dopamine, norephinephrine, and serotonin, a property shared
by amphetamines and partially shared by other diet drugs like phenylpropanolamine
(PPA) and antidepressants (which typically inhibit the uptake of just one
biogenic amine). Together the Food and Drug Administration (FDA) and its European
counterpart, the European Medicines Evaluation Agency (EMEA), tentatively
attributed 34 deaths worldwide to the drug, of which 25 occurred in the U.S.
of these 25 deaths, 16 were due to cardiac events. Some five thousand adverse
events have been spontaneously reported in the U.S., with 306 involving cardiac
events.
Prior to Public Citizen's appeal for a recall of the drug, FDA (March 15,
2002) and EMEA (March 21, 2002) had announced that they were opening investigations
into the safety of sibutramine, in view of the adverse events reported. FDA
had previously issued a warning letter (Oct 22, 1998) to the sponsor concerning
inadequate attention to side effects including the fact that sibutramine is
a schedule 4 drug. This classification indicates that the perscription drug
has abuse, dependence, or addiction potential, adding to the negative perception
of diet pills, such as fenphen.
An FDA advisory panel voted against Meridia's approval in 1996, based on an
unfavorable risk/benefit ratio.
Meridia lawyer filed Meridia class action.
No action: The American Medical Association (AMA) and American Heart Association
have not adopted policies on Meridia adverse events. Substantial medical questions
remain in the trade-off between the dangers of diet drugs compared to obesity,
both for women's health and men's health.
Update (May 24, 2002):
The national public interest group Public Citizen contends the pharmaceutical
company Abbott Labs concealed information from the FDA about the dangers of
the diet drug Meridia.
Dr. Sidney Wolfe, Director of Public Citizen?s Health Research Group, said
in a letter to Health and Human Services Secretary Tommy Thompson that Abbott
had failed to report the death of a Meridia user.
Wolfe, who also called for the recall of Meridia in March, went over the head
of the FDA this week to report directly to Thompson. In his letter, Wolfe
said he believed Abbott failed to disclose some of the evidence that would
link Meridia to the deaths of certain users, and asked that criminal charges
be brought.
Meridia has been implicated in the deaths of 29 users in 3 years from apparent
cardiac complications.
Abbott so far has not voluntarily withdrawn Meridia from the market. Abbott
Labs refutes the claim that Meridia caused these deaths and accuses Public
Citizen of misleading and alarming physicians and patients.
Meridia
Pharmacology - a report by John Lehmann PhD