Tuesday, September 25, 2012

19,000 Aussie Kids Use Janssen Cilag Concerta For ADHD After It Was Rejected For Adults

The Herald Sun has;
19,000 Kids Use Rejected 'Unsafe' ADHD Drug Concerta

AN ADHD drug rejected for a government subsidy because of "uncertain safety" in adults is being subsidised for children and was used by over 19,000 kids in the last year.
A subsidy for the medicine Concerta, a long acting form of ritalin, was recently knocked back for adults by the government's expert Pharmaceutical Benefits Advisory Committee "on the basis of uncertain efficacy and safety in the proposed PBS [Pharmaceutical Benefits Scheme]  population".

The PBAC was also concerned about the "highly uncertain cost to the PBS" if it did subsidise the drug, otherwise known as methylphenidate, with experts speculating this could be because the medicine could potentially be diverted for illegal use.

Anti ADHD drug campaigner and WA MP Martin Whitely says it is a "seemingly absurd inconsistency that the drug is not considered safe enough for adults but is considered safe for children".

"I argue that if Concerta isn't proved to be safe enough for adults there is no way it should be given to children," he said. 

A spokeswoman for the Department of Health and Ageing said a separate government body -  medicines watchdog the Therapeutic Goods Administration - had assessed Concerta as "safe and effective for adults". 

"However, in making its recommendation I can confirm that the PBAC took into account the cost effectiveness of the drug in comparison with alternative therapies for adults," the spokeswoman said.

The Electronic Medicine Compendium website, which contains information from the Concerta manufacturing company Janssen Cilag, warns "long-term use of methylphenidate has not been systematically evaluated in controlled trials".

The drug has been linked to a (10mmHg) rise in blood pressure in children, been associated with sudden death in those with cardiac abnormalities, can make aggression and hostility worse, produce the onset of tics and cause reduced weight gain and growth retardation. 

An eight year WA study on the use of psychostimulants in kids found they increased the probablility of a child medicated for ADHD falling behind at school by 950 per cent.

The nation's drug watchdog the Therapeutic Goods Administration has received 42 reports of adverse events linked to the drug  in the last decade including two cases of suicidal ideation, two cases of self injury, four cases of agression and another four cases of hallucination. 

Child psychiatrist Jon Jureidini, who heads the department of Psychological Medicine at Flinders University, says he thinks the drug is prescribed for too many children and given there is a rare chance it could kill children with heart problems it should be used "very rarely".

Janssen Cilag told the PBAC  the medication was already subsidised on the PBS for adults who were diagnosed with ADHD before they turned 18.

"This submission requested the same access for all adult patients regardless of the age at which they were diagnosed," the company said.

The company is consulting with the PBAC about a future submission.

Thank You HeraldSun and Ms Dunlevy

Here's the Drug in Question
Ritalin/Concerta Side Effects

Here's the Company in Question

Hat Tip To Mad In America

No comments: