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Mar 23, 4:46 AM EST
Advisers Reject Strong ADHD Warnings
By ANDREW BRIDGES
Associated Press Writer
WASHINGTON (AP) -- Federal health advisers said Wednesday that
Ritalin and other drugs for attention deficit hyperactivity disorder
should not carry strong "black-box" warnings about potential
cardiovascular and psychiatric risks.
Rather, the Food and Drug Administration pediatric advisory
committee recommended that the drug labels include warning language
written so people can understand it. "I wouldn't use the word
'tougher,' said panel chair Dr. Robert Nelson, of the Children's
Hospital of Philadelphia. "'Clearer.'"
By rejecting the black-box warnings in a consensus decision, the
advisory panel broke with another committee that voted just last
month to include them on some ADHD drugs.
The FDA was poised Wednesday to follow the more recent
recommendations.
"I think we are likely to follow them, yes," said Dr. Robert Temple,
director of the FDA's office of medical policy, following the
meeting.
Any updated language may not appear on labels until pharmaceutical
companies begin using a recently adopted format, something that
could take several years. And the FDA may yet require black-box
warnings on stimulants to treat ADHD that would alert adults to
increased risk of heart attacks, strokes and other similar problems,
Temple said.
Nearly 3.3 million Americans age 19 and younger used an ADHD drug
last year, according to Medco Health Solutions Inc., a prescription
drug benefit program manager.
Psychiatrists and others had urged the committee to move cautiously
before recommending strengthened warnings associated with the drugs.
In February, the FDA's Drug Safety and Risk Management advisory
committee voted to recommend the agency add the strongest possible
warning to some of the drugs regarding their potential
cardiovascular risk.
The FDA then asked the pediatric panel to examine that same issue,
as well as reports that psychosis or mania can occur in some
juvenile patients at normal doses of any ADHD drug.
Adding black-box warnings to some or all the drugs, which also
include Adderall and Strattera, could cause more harm than good,
some experts told the panel.
"I suggest confusion, polarizing viewpoints, initial press hysteria.
But then what?" asked Julie Zito, a University of Maryland associate
professor in pharmacy and psychiatry.
The FDA has struggled since last year with the question of how to
communicate the potential risks associated with ADHD drugs. It now
appears likely the warnings will come in the form of highlighted
language on drug labels, as well as guides distributed - admittedly
infrequently, FDA officials said - to patients.
Psychiatrists and mental health advocates said leaving the disease
untreated could rival the risks the drugs may pose.
"It is important to not let the discussion of ADHD medications
overshadow the public health crisis of untreated mental health
disorders in children," said Cynthia Wainscott of the National
Mental Health Association. Her 16-year-old granddaughter has ADHD.
Ritalin is manufactured by Novartis Pharmaceuticals Corp. and in
generic form by other companies; Adderall is made by Shire
Pharmaceuticals Inc.; and Strattera, which is produced by Eli Lilly
and Co.
Earlier Wednesday, FDA officials say patients and doctors should be
aware that the small number of reported psychiatric events,
including hallucinations, could represent side effects of the drugs,
although they cannot point to a definitive link.
The new labels should counsel parents to watch for such events and
to both talk to their doctors and consider halting treatment, Nelson
said.
McNeil Consumer & Specialty Pharmaceuticals said in briefing
documents that it is customary to weigh the "therapeutic benefits
and potential risks" of treatment. The unit of Johnson & Johnson
makes Concerta, a long-acting form of methylphenidate, the drug in
Ritalin.
Novartis believes current Ritalin labels are adequate, company
medical safety director Dr. Todd Gruber said.
Jacqueline Bessner of Ishpeming, Mich., said her daughter, Leanne,
15, hanged herself last year two months after starting treatment
with Concerta. Bessner said more black-box warnings would be useless
without increased counseling and monitoring of patients.
"It's being handed out like it's candy," Bessner said of ADHD drugs.
"It's too easily accessible."
A different FDA panel planned to consider on Thursday an application
by Cephalon Inc. to sell its sleep-disorder drug Provigil, or
modafinil, as an ADHD treatment for children.
The FDA wants members of its psychopharmalogic drugs advisory
committee to examine that request, including whether serious skin
rashes seen in children treated with modafinil should merit special
warnings, follow-up studies and steps to limit the risk. |
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