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ADHD warning
label at issue
(June
2006 Issue)
By Pamela Berard
Armed with two different recommendations, the Food and Drug Administration
is deciding what sort of warning will appear on the labeling of
Attention-Deficit/Hyperactivity Disorder medications.
In February, the Drug Safety and Risk Management Advisory Committee
voted 8-7-1 to recommend the agency require black-box warnings on
the labels of ADHD drugs regarding cardiovascular events. A black-box
warning is the most serious warning placed in the labeling of a
prescription medication. Advertisements that serve to remind health
care professionals of a product's availability are not allowed for
products with black box warnings, according to information from
the FDA.
But in March, the FDA Pediatric Advisory Committee panel determined
that black-box warnings are not warranted. David Fassler, M.D.,
clinical professor of psychiatry at the University of Vermont College
of Medicine and co-founder of Walden Behavioral Care in Waltham,
Mass., testified during the hearings.
"The advisory panel included parents, advocates and physicians
with expertise in the evaluation and treatment of children and adolescents
with psychiatric disorders. The discussion was thoughtful, inclusive
and firmly based on a careful review of the data presented," Fassler
says. "At the end of the hearing, none of the panel members supported
the imposition of additional 'black-box' warnings with respect to
the use of these medications in pediatric populations.
"Instead, they recommended updating the existing labeling, where
appropriate, based on the research currently available. They also
discussed the development of additional 'med guides' to provide
parents and adult patients with even more information about the
risks, benefits and potential side effects of these medications."
The FDA staff and panel members agreed that these medications are
highly effective at treating the core symptoms of ADHD, Fassler
says. "They also felt they were generally well tolerated, and that
serious side effects were relatively rare.
"For these reasons, they concluded that additional black-box warnings
were not warranted. Both staff and panel members also expressed
concerns that such warnings, if imposed, could ultimately reduce
access to effective and appropriate treatment for children and adolescents
with ADHD."
Fassler adds, "Personally, I support the recommendations of the
advisory committee. I agree that patients, family members and physicians
need and deserve as much information as possible about the safety
and efficacy of medications in order to make fully informed decisions
about treatment options. I also think that regulatory decisions
must be firmly based on the available science."
During the hearing, Fassler recommended large-scale, multi-site
studies with long-term followup, and MedGuides that present information
about potential risks and benefits in a balance context.
However, Steven Nissen, M.D., a Cleveland Clinic cardiologist and
consultant to the Drug Safety and Risk Management Advisory Committee,
believes the black-box warnings are warranted to slow down the prescribing
of such drugs, use of which he says has gone up "exponentially."
Nissen refers to the high number of preadolescent boys who are
being treated with ADHD drugs. He referenced one fifth-grade classroom
where 70 percent of the boys are taking amphetamines.
"I simply can't believe that that's good public policy," he says.
"The real question is, 'Do we think that 10 percent of 12-year-old
boys have a disease that requires giving them powerful drugs?' I'm
not sure that is true."
Nissen says he wants people to be aware that there are risks associated
with taking the drugs.
"These are powerful drugs. The entire class of drugs is very much
suspect. So I took the position that giving powerful stimulants
is something that people need to be worried about. I didn't recommend
that these be removed off the market. I think the reaction by the
psychology community to resist that warning is not wise," he says.
According to FDA data, about 2.5 million children and 1.5 million
adults are now taking stimulant medications during any 30-day period.
Many people have become "cavalier" about taking medication, Nissen
says. "The drugs should be used more selectively and with knowledge
of the risks."
Nissen says he has "no hope" the FDA would approve the black-box
warnings but he is hoping the vote would give some momentum to discussion
on the issue.
Karen Mahoney, trade press liaison of the FDA's Center for Drug
Evaluation and Research, says FDA has contracted with the Institute
of Medicine for a review and recommendations as to how FDA should
improve safety efforts for all drugs. The recommendations are expected
this summer, Mahoney says.
Mahoney says the FDA expected the implementation of labeling changes
to occur in stages. She adds that the FDA is considering the use
of a Medication Guide, which was recommended by both committees.
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