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Child drugs linked to heart attack
Clara Pirani, Medical reporter
27mar06
CHILDREN as young as five have
suffered strokes, heart attacks, hallucinations and convulsions after taking
drugs to treat attention deficit hyperactivity disorder.
Documents obtained by The Australian reveal that almost 400 serious adverse
reactions have been reported to the Therapeutic Goods Administration, some
involving children as young as three.
Cases include the sudden death of a seven-year-old, and a five-year-old
who suffered a stroke after taking Ritalin. Children also experienced heart
palpitations and shortness of breath after taking Dexamphetamine.
Others taking Ritalin or Dexamphetamine - the two most commonly used ADHD
drugs - experienced hair loss, muscle spasms, severe abdominal pain,
tremors, insomnia, severe weight loss, depression and paranoia.
Almost 60 of the adverse-reaction reports dating back to 1980, obtained
under Freedom of Information laws, involved children under the age of 10.
The TGA has asked pharmaceutical companies to provide updated information
about any cardiovascular side effects involving ADHD medication. "The TGA is
currently reviewing this new information," a TGA spokeswoman said.
Prescriptions for Ritalin increased tenfold after the drug was listed on
the Pharmaceutical Benefits Scheme in August last year, reducing the cost
from $49 to $29.50, or $4.70 for concession card holders.
More than 5800 prescriptions were written for Ritalin in January this
year, compared with 523 in August last year. Prescriptions for
Dexamphetamine jumped from 96,000 a year to 232,000 in the 10 years to
2004-05.
The US Food and Drug Administration is reviewing 90 studies to determine
whether ADHD drugs were linked to the deaths of 25 people, including 19
children, between 1999 and 2003.
The drugs were also associated with 54 cases of cardiovascular episodes,
including heart attacks, strokes and serious heartbeat disturbances.
Last week, a panel of pediatric experts advising the FDA recommended new
information about psychiatric and heart risks be added to the labels of ADHD
drugs.
They declined to recommend the "black box" warning - the strongest for
prescription drugs - which a different advisory panel endorsed last month.
The FDA will consider both panels' recommendations before making a final
labelling decision.
While officials said there was no conclusive evidence that the
medications caused psychiatric episodes or heart problems, they noted a
"complete absence" of similar reports in children treated with placebos
during trials of ADHD drugs.
A spokeswoman for Novartis Australia, which makes Ritalin, said warnings
regarding adverse reactions were constantly reviewed. "We welcome the
opportunity to work with the TGA to ensure the labelling is as accurate as
possible," she said.
Melbourne psychologist Joe Tucci said some ADHD drugs had the potential
to cause long-term side effects.
"There is certainly a small group of children who would benefit from ADHD
drugs, but it's far fewer than the number of children who are currently
being prescribed medication," he said.
Others warned that the number of adverse reactions may be much higher
because the TGA excludes reports where the cause of side effects is
"unclear". Shelley Wilkins, executive director of the Citizens Commission on
Human Rights, which lobbies against the use of psychiatric medication on
children, said many side effects were not reported.
"There is no mandatory reporting in Australia for adverse side-effects
for psychiatric drugs," she said. "This needs to be rectified immediately so
we can see the true extent of the damage being done."
Fremantle psychiatrist Lois Achimovich said doctors were prescribing
medication too often, particularly in very young children.
"Any child behaviour that looks abnormal is being diagnosed as ADHD and
drugs are prescribed. They should not be used in children that young."
http://www.theaustralian.news.com.au/printpage/0,5942,18614238,00.html
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