ADHD Drug Reactions: Over The Top Down Under?
5 CommentsBy Ed Silverman // October 14th, 2009 // 7:08 am
The opposition party in Australia says the federal government has failed to properly regulate ADHD drugs, with acting opposition health spokesman Mathias Cormann charging that Health Minister Nicola Roxon has done nothing for almost two years, according to The Sydney Morning Herald.
His comments follow reports 30 children have wanted to kill themselves while on AHDD meds. One seven-year-old boy became so depressed while taking Ritalin last year that he tried to commit suicide and an eight-year-old hallucinated that spiders were crawling up his skin, the paper writes. Overall, the number of serious reactions to ADHD drugs has doubled in a three-year period, according to Therapeutic Goods Administration figures.
The former coalition government asked the Royal Australasian College of Physicians to review clinical guidelines for treating ADHD in its last year in office.”At the time, Ms Roxon was highly critical of the Howard government but now two years later she has failed to produce any guidelines,” Senator Cormann said in a statement. “What has this minister been doing?”
The National Health and Medical Research Council is currently upgrading the guidelines. But Senator Cormann said Labor had “failed” to implement the new standards. Reports children were becoming suicidal after having severe psychotic episodes were “very concerning”, he said. Acting Health Minister Justine Elliot wasn’t immediately available for comment, according to the Morning Herald.
Ted Chabasinski
I think it is fantastic that regulating these drugs has become a mainstream political issue in Australia. Hre in the US, one would never know that out politicians even know that such a problem exists.
Ron Kavanagh
I think it’s fascinating that there’s been a sudden increase in reporting over the last few years.
I was an FDA reviewer and I worked on ADHD meds and antipsychotics since 2002. Several years ago I presented at the FDA advisory committee on methylphenidate induced psychosis in children. At the time this was required under new pediatric drug laws.
These types of reactions with methylphenidate (Ritalin/Concerta) have been known about for years and can be first found in the 1973 edition of Goodman and Gilman’s ‘The Pharmacological Basis of Therapeutics’, the standard pharmacology textbook for almost any physician, dentist, pharmacist, or pharmacologist for years. In fact since 1969 it has been recommended in the literature that you start with a low dose and then go up because of this. This makes sense since it will wear off after as soon as sufficient drug has left your body which will be sooner with lower doses.
The entire episode with labeling on this issue for several years before the advisory committee, the circumstances surrounding the ac meeting itself, and labeling since then has all been very strange. In fact I was being told to define psychosis for the AC meeting as simply irritability due to the drugs. I was also told that these reactions (irritability) should mean that methylphenidate should be contraindicated as that the child may really have bipolar disorder. In every methylphenidate drug study since the 1960’s irritability occurs in about 1% of treatment naive patients.
To give you an idea of how strange it was FDA manager Shirley Murphy (ex-VP of pediatric marketing for Glaxo) was pushing this idea of methylphendiate induced psychosis via the press prior to the AC meeting and when I was at the last minute able to show it wasn’t really a big deal FDA shut up and then said they had to confirm my results and it took them a year to verify through post marketing reports what had been found in all the controlled clinical trials up to that point. They didn’t want to look at the data they just wanted to push the idea that these drugs induced psychosis, but for the 3 years before then they wouldn’t let me make it clear in the labeling that they do cause it occassionally.
Of the cases reported to the FDA and presented at the AC meeting most were dose related and weren’t really psychosis and the only one that clearly was psychosis which was unrelated to dose was in an 18 year old. (it occurred with the very first dose which was very small.)
Presently there are statements in methylphenidate product labeling prompting prescribers to think of bipolar illness in children. I now believe that raising these concerns about psychosis was really designed to instill concern that even lessor side effects with the methylphenidate products may mean bipolar illness and to help with shunting patients to using more expensive antipsychotics.
With the increased usage of antipsychotics in children for ‘bipolar disorder’ and even ADHD without bipolar disorder. Especially in combination with stimulants (50% of patients in Seroquel pediatric bipolar studies per the AC meeting). I’m not surprised that we’re seeing an increased incidence of true psychotic reactions and suicidality as both of these are side effects due to the antipsychotic drugs. (Publicly available data).
Ron Kavanagh
Pediatric Clinical Pharmacologist
talbot
Australians are protective of children in a way that the US will never be. A lot of American children are like the chickens in the industrial farms, cooped up, wings clipped, and controlled by whatever means to produce a consistent product. Australian kids are treated much more kindly and gently, without the incessant need to be cornered into a “type”. If ADHD drugs harm children–as this evidence seems to indicate–the data are going to come from a place like that, and not the US.
anon
Unfortunately, many parents and docs in the U.S. seem to want a label for children/minors who don’t behave in exactly the way they would like them to. It’s easier to medicate a child than to deal with them as they are. I read somewhere recently of a child as young as 5 being diagnosed with bipolar disorder, which I think is ridiculous. It is considered a mood disorder, but children are not physically or mentally mature yet, and as such cannot be expected to be able to have stable moods over a period of time. (I’ve heard that the human brain does not stop developing until age 25 in either gender.)
anon
Also, there is a tendency sometimes to look for a solution to problems in a pill, which often ends badly. (I make comments about the U.S. as someone is a U.S. citizen.)