| Roman Bystrianyk 2005-03-26, 9:50 am |
| http://www.healthsentinel.com/news....ist_item&id=703
"Public Citizen Petitions FDA to Take Pemoline Off the Market", Common
Dreams, March 24, 2005,
Link: http://www.commondreams.org/news2005/0324-02.htm
Public Citizen today petitioned the U.S. Food and Drug Administration
(FDA) to immediately remove pemoline (Cylert), a central nervous system
stimulant used in the treatment of attention deficit hyperactivity
disorder (ADHD), from the market because it is known to have caused at
least 21 cases of liver failure, including 13 resulting in liver
transplantation or death.
In its petition, the consumer advocacy organization noted that the
drug's unfavorable risk-to-benefit ratio has led to its withdrawal in
the United Kingdom and Canada while the FDA instead opted for two
separate black box warning labels that a 2002 FDA study shows were
ineffective in reducing the drug's risks. "In light of this
evidence of unique liver toxicity without evidence of unique
therapeutic benefit, we contend that the only responsible course of
action is to remove this dangerous drug from the market," states the
petition.
Pemoline originally appealed to clinicians because it allowed
once-a-day dosing, as opposed to multiple daily doses that might raise
logistical problems, especially for children in school during the day.
However, due to the development of long-acting formulations of other
stimulant medications, this is no longer a unique characteristic,
Public Citizen's petition says. In 2004, approximately 117,000
pemoline prescriptions were filled in the United States.
Reports of liver abnormalities appeared in U.S. clinical trials even
before the drug was approved by the FDA in 1975. Between the 1975
approval and 1996, there were 193 adverse drug reactions involving the
liver ascribed to pemoline reported to the FDA that involved patients
under the age of 20. As of May 1996, there were 13 cases of acute liver
failure due to pemoline, 11 of which resulted in death or liver
transplantation.
An FDA analysis by Dr. David Graham, who testified at congressional
hearings about Vioxx safety concerns, estimated a 16.8-fold increased
risk of acute liver failure due to pemoline compared to the general
population, assuming no underreporting. Given that adverse events are
reported to the FDA about 10 percent of the time, the relative risk for
acute liver failure could be closer to 168-fold.
The maker of pemoline, Abbott Laboratories, challenged the FDA's
conclusion in 1996 that pemoline had "an unfavorable risk to benefit
ratio" and should be withdrawn from the market. Abbott was allowed to
continue marketing the drug by adding a black box warning and by
sending a letter to all U.S. physicians warning about pemoline's
liver toxicity and recommending that it should no longer be considered
a first-line therapy for ADHD.
A stronger black box warning urging periodic liver tests was issued in
June 1999 as liver failure cases continued to accumulate. An FDA study
demonstrated that most physicians were not doing the recommended
testing.
"The Food and Drug Administration should immediately ban the sale of
pemoline," said Dr. Sidney Wolfe, director of Public Citizen's
Health Research Group. "Relatively safe and effective drug treatments
exist for ADHD, and since there are no data that demonstrate pemoline
has any unique benefit over other drugs, there is no responsible basis
for keeping this unacceptably dangerous drug on the market."
Public Citizen is joined in its petition to the FDA by Dr. Fredric
Solomon, clinical professor of psychiatry and behavioral sciences at
the George Washington university School of Medicine, who in the course
of 42 years of clinical experience has evaluated and cared for hundreds
of patients with ADHD.
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