Child drugs linked to heart attack, strokes, hallucinations and convulsions

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The Austrialian

 

Child drugs linked to heart attack

Clara Pirani, Medical reporter

March 27, 2006

 

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. "