Child drugs linked to heart attack

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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."
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Child drugs linked to heart attack
By Clara Pirani, The Australian Medical reporter
March 27, 2006

Link
 
Why the fuck are doctors prescribing amphetamines and ritalin to five year olds? Jesus Christ, that's just wrong on so many levels.
 
Wow, all these negative stories recently with ADD drugs, how come they are still leagal to sell and prescribe ??? (Hint , Hint...) :\
 
Fucking legal drug dealers and their lobbying. Those people don't give shit about helping kids, they could watch hundreds die, as long as they are making money.
 
I know several people who are all deepley convinced that ritalin(methyphenidate) given to them around age 5-7 was somehow responsible for the development of a skin condition called 'vitiligo'. It is basically areas of skin that lack pigment. It has been explained here on bluelight that this probably occured because of an:

"(Auto-immune attack on the cells which produce pigment in your skin (melanocytes)).>"

caused by ritalin's effects on the auto-immune system.
 
Drug chiefs called in after children suffer strokes

AN urgent investigation has been launched into claims drugs used to treat attention deficit hyperactivity disorder could be killing children.

Parliamentary Secretary for Health Christopher Pyne will also meet pharmaceutical company executives this week to discuss whether such drugs should carry stronger warnings.

Mr Pyne yesterday said he had requested an urgent meeting with Novartis Australia, in response to a report in The Australian that children as young as five had suffered strokes, heart attacks, hallucinations and convulsions after taking ADHD medication.

Documents obtained by The Australian revealed almost 400 adverse reactions had been reported to the Therapeutic Goods Administration, some involving children as young as three.

"I've asked the people of Novartis, who are the makers of Ritalin, to come and see me this week and explain why Ritalin shouldn't have a black box applied to it," Mr Pyne said.

Black box warnings signify that a drug may cause dangerous side-effects. They are the strongest warnings that can be issued by drug regulators.

"The problem is that doctors are inappropriately prescribing Ritalin because they think it's the wonder drug for children with ADHD," Mr Pyne said.

"I'm very concerned about this. Parents are entitled to expect the Government to protect them from those kind of (drugs) that lead to the deaths of their children. I have spoken to the head of the TGA and directed him to fast-track an investigation of the use of Ritalin, including speeding up discussions with the FDA in the United States, who are also investigating."

A spokeswoman for TGA said there was no conclusive evidence ADHD was linked to sudden death or cardiovascular episodes. However, data obtained by The Australian showed the TGA's reports lacked detailed information about the side-effects experienced by dozens of children. Many of the reports failed to note the patient's age.

In more than 60 cases the TGA did not conduct any follow-up investigation to find out whether individuals recovered from the side-effects.

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Drug chiefs called in after children suffer strokes
Clara Pirani and Patricia Karvelas
March 28, 2006

Link
 
Dark side of a wonder drug

Not only do drugs prescribed to combat hyperactivity in children have frightening side effects, they may not be necessary, writes medical reporter Clara Pirani

FOR almost two years Janine Ritson ignored doctors and teachers who told her to medicate her son. Hyperactive, inattentive and angry, the seven-year-old was virtually uncontrollable. "He would fly off the handle at the slightest thing," Ritson says. "He couldn't cope with any change to his routine and he was falling behind in school."

Ritson's son was diagnosed with attention deficit hyperactivity disorder. "I really did not want to give him drugs but after years of hearing that he needed medication, I thought I'd give it a try," she says.

Ritson started her son on a low-dose course of dexamphetamine, one of the most commonly used ADHD drugs in Australia. The relieved mother says the change in her son's behaviour was startling. He was less angry, calmer and easier to control, much to the delight of his frustrated teachers. But the drug also caused alarming side effects.

"He started hallucinating," Ritson says. "He said he could hear monsters and voices in his head that wouldn't stop. And he stopped sleeping. He would still be wide awake at two in the morning."

Ritson sought advice from her doctor and was told to give her son a sleeping pill in combination with the dexamphetamine.

"That was it for me," she says.

"I thought it was ridiculous being told to give him tablets to make him be good and then tablets to make him sleep. I thought, 'If he can't fit in the school system, I'll have to home-school him."'

Ritson stopped giving her son dexamphetamine and, after much research and consultation with specialists, started her son on a strict diet that excluded all chemicals and preservatives.

"It's worked really well for him," Ritson says. "He's 10 now and he's like a different child. He has friends, he's doing better in school and he's much calmer."

Ritson's experience is not uncommon. Documents obtained by The Australian this week reveal almost 400 adverse reactions to ADHD drugs have been reported to the Therapeutic Goods Administration, some involving children as young as three. Children as young as five have suffered strokes, heart attacks, shortness of breath, hallucinations, muscle spasms and convulsions.

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.

The data raises questions about whether pharmaceutical companies and drug regulators are providing reliable information about the side effects of these widely prescribed medications.

The use of ADHD drugs has rocketed in the past decade. Prescriptions for dexamphetamine jumped from 96,000 a year to 232,000 in the 10 years to 2004-05. Prescriptions for Ritalin increased 10-fold 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.

ADHD is now the most commonly diagnosed psychiatric condition among school-age children. In 2000, a federal government report, the National Survey of Mental Health and Wellbeing, surveyed 4000 people in Australia and found that 11 per cent of parents thought their child had ADHD.

Yesterday, parliamentary secretary to the health minister Christopher Pyne said the federal Government would investigate whether the warnings about ADHD medication were adequate.

"I've asked the people of Novartis, who are the makers of Ritalin, to come and see me this week and explain why Ritalin shouldn't have a black box applied to it," he says.

Black boxes are placed on drug labels to signify the drug may cause dangerous side effects. They are the most serious warnings issued by drug regulators.

The US medication watchdog, the Food and Drug Administration, is considering whether all ADHD drugs should carry black boxes. The FDA is also investigating whether ADHD drugs were linked to the deaths of 25 people, including 19 children, and 54 cases of cardiovascular episodes, including heart attacks, strokes and serious heartbeat disturbances, between 1999 and 2003.

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. The panel declined to recommend the black box warning, which a different advisory panel endorsed last month.

The FDA will consider both panels' recommendations before making a final labelling decision.

Although FDA officials say there is no conclusive evidence that the medications cause psychiatric episodes or heart problems, they note a "complete absence" of similar reports in children treated with placebos during trials of ADHD drugs.

Pyne says the TGA should work with the FDA to review warnings about potential side effects caused by ADHD medication.

"The problem is that doctors are inappropriately prescribing Ritalin because they think it's the wonder drug for children with ADHD," Pyne tells The Australian. "I'm very concerned about this. Parents are entitled to expect the Government to protect them from those kind of [drugs] that lead to the deaths of their children. I have spoken to the head of the TGA and directed him to fast-track an investigation of the use of Ritalin, including speeding up discussions with the FDA in the US, who are also investigating."

However, a spokeswoman for the TGA says the regulator has adequate systems in place to monitor adverse events.

"Reporting of adverse drug reactions is just one of the methods utilised by the TGA to monitor the safety of medications," she says. "Other tools include thorough evaluation of all safety and efficacy information prior to approval of a medicine for registration in Australia [and] information sharing with international regulators regarding adverse drug reactions."

Drug companies must also report serious side effects that occur in Australia to the TGA within 15 days of becoming aware of the reaction, a system that relies on consumers or doctors reporting the adverse reactions to the drug company.

"It must be emphasised that, at this stage, no causal relationship has been established between the use of stimulant medicines registered for use in ADHD and sudden death, nor is there clear evidence in the US," the TGA's spokeswoman says.

However, the data obtained by The Australian shows the TGA's reports lack detailed information about the side effects experienced by dozens of children. Many of the reports fail to note the patient's age.

In more than 60 cases, the TGA did not conduct any follow-up investigation to find out whether the individual recovered from the side effects they experienced.

The cases where the outcome was recorded as unknown involved a 12-year-old who suffered heart palpitations, a four-year-old with anorexia and vomiting, and an eight-year-old who experienced hair loss.

Jon Jureidini, the head of the department of psychological medicine at the Women's and Children's Hospital in Adelaide, says many adverse reactions are not reported to the TGA.

"We doctors are very poor at reporting adverse drug reactions," Jureidini says. "Most of trainees who rotate through our unit don't even know what the forms look like. I think the drug companies, the TGA and the doctors ourselves are all failing the community in the area of monitoring adverse events."

Jureidini says claims by drug regulators and pharmaceutical companies that the number of adverse reactions are minimal when compared with the number of people who take ADHD medication cannot be substantiated.

"You can't rely on the actual number of adverse reaction reports versus the number of people taking the medication as any kind of estimate of the incidence of adverse events," Jureidini says. "The number of adverse events will always be grossly underestimated because we are so bad at reporting."

Jureidini claims there is also a lack of reliable data about the long-term use of ADHD medication on young children.

In September last year an analysis of more than 2200 studies into 16 drugs, including Ritalin and dexamphetamine, found there was no solid evidence about the long-term effect of ADHD drugs.

The review was conducted by the Drug Effectiveness Review Project at Oregon State University, a research group set up by 12 US states to provide independent information about some of the more commonly used drugs. It warned there were no good quality studies that examined the long-term safety of ADHD drugs.

"Good-quality evidence on the use of drugs to affect outcomes relating to global academic performance, consequences of risky behaviours, social achievements etc is lacking," the study found.

Joe Tucci, a psychologist and chief executive of children's welfare group the Australian Childhood Foundation, says the medication should not be given to young children, whose brains are still developing.

"I don't think we know enough yet about the long-term consequences of using this medication, especially when children are taking it every day for years," he says.

Tucci says medication can help a small number of children with severe behavioral problems. However, he says, doctors are prescribing medication far too often.

"The medical profession and the drug companies have pushed the model that really difficult children's behaviour can always be explained as a medical problem that requires a medical solution, which is a drug," Tucci says. "We've come to use medical intervention as a way of treating internal or emotional difficulties in children."

Lois Achimovich, a Fremantle psychiatrist with 30 years' experience, says many parents don't want to give their children medication but increasingly they don't have a choice.

She claims the lack of affordable mental health services in Australia has left parents without any support.

"Counselling should always be tried before drugs are given but there are waiting lists, in Western Australia, for example, of more than a year to get a child and adolescent mental health appointment," Achimovich says. "Any child behaviour that looks abnormal, parents think is ADHD, and they know that there's medication for it. Pills have become a cheap alternative to this problem."

Ritson says that finding an alternative to medication is a long and expensive process.

"It's really hard because you know your kids are suffering and you are told by teachers and doctors that they should be medicated," she says. "It has been an expensive, long road. We've had every possible test done, we went to lectures about alternative treatments and spent nights looking at papers on the internet, but it was worth it."

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Dark side of a wonder drug
Clara Pirani
March 28, 2006
 
i think its pretty obvious and rediculous that children this young are being prescribed these stimulants. obviously, the children are still growing and i think drugs like this can really mess with the composition of the body when it is still growing so rapidly. Kids that young arent supposed to pay attention all the time they are supposed to act wild and crazy sometimes. THEY ARE KIDS! i think its a cop out from the parents not trying to fill there parental duties by trying to put there kids on these drugs. its just rediculous
 
This just goes to show that people need to be more aware of the drugs themselves and not just blindly follow the directions of the good doctor. I consider it the parents responsibility to safeguard their children and there is no-way I would allow my child access to any stimulants until they are at least 14 years old. Handing out pharmaceutical grade stimulants to 5 year olds is totally wreckless to all parties concerned.
 
jond2005 said:
i think its pretty obvious and rediculous that children this young are being prescribed these stimulants. obviously, the children are still growing and i think drugs like this can really mess with the composition of the body when it is still growing so rapidly. Kids that young arent supposed to pay attention all the time they are supposed to act wild and crazy sometimes. THEY ARE KIDS! i think its a cop out from the parents not trying to fill there parental duties by trying to put there kids on these drugs. its just rediculous(sic)
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Don't forget that some kids genuinely *do* have these neurobiological disorders. Don't get me wrong, I personally think that these medications are often overprescribed, but some people genuinely need it.

As a person with Asperger Syndrome, I had a lot of trouble at school "fitting in" and being able to both learn and socialise in the same setting. I became very depressed during Year 8 & 9, and had the option of medication, but chose not to. It was a very difficult period of my life, and to this day I'm still not sure how I managed to survive it! On the same note, a good friend of mine that I met through a parent support network was greatly helped by medication, despite being on both antidepressants and depresants (to counter the hyperactivity caused by the antidepressants, which I thought was ridiculous, but it seemed to work for him, which is what matters). It's a complicated situation, one that can't be fixed by simply removing the medication altogether, or prescribing it to everyone with one or two symptoms of ADHD.

That said, counselling is *always* a better option - medication for these disorders should be a last-resort. I definitely agree with Smyth about kids that young on stimulants being reckless.
 
"I don't think parents are unwilling to deal with their kids necessarily. I think the medical establishment convinces them that these drugs are necessary for their children to lead healthy and happy lives."

I think it's a whole lot of both.
 
Raw Evil said:
Don't forget that some kids genuinely *do* have these neurobiological disorders. Don't get me wrong, I personally think that these medications are often overprescribed, but some people genuinely need it.

As a person with Asperger Syndrome, I had a lot of trouble at school "fitting in" and being able to both learn and socialise in the same setting. I became very depressed during Year 8 & 9, and had the option of medication, but chose not to. It was a very difficult period of my life, and to this day I'm still not sure how I managed to survive it! On the same note, a good friend of mine that I met through a parent support network was greatly helped by medication, despite being on both antidepressants and depresants (to counter the hyperactivity caused by the antidepressants, which I thought was ridiculous, but it seemed to work for him, which is what matters). It's a complicated situation, one that can't be fixed by simply removing the medication altogether, or prescribing it to everyone with one or two symptoms of ADHD.

That said, counselling is *always* a better option - medication for these disorders should be a last-resort. I definitely agree with Smyth about kids that young on stimulants being reckless.
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yes u are right, some kids do have needs but i dont think amphetamines such as adderall are the solution, these increase blood pressure and put stress on the heart and the whole circulatory system, do u really think kids under 10 really need this kinda stress on there bodies when at this age? i dont think so.

i def think there are alternatives such as counseling our maybe other medications
 
Raw Evil said:
Don't forget that some kids genuinely *do* have these neurobiological disorders. Don't get me wrong, I personally think that these medications are often overprescribed, but some people genuinely need it.

As a person with Asperger Syndrome, I had a lot of trouble at school "fitting in" and being able to both learn and socialise in the same setting. I became very depressed during Year 8 & 9, and had the option of medication, but chose not to. It was a very difficult period of my life, and to this day I'm still not sure how I managed to survive it! On the same note, a good friend of mine that I met through a parent support network was greatly helped by medication, despite being on both antidepressants and depresants (to counter the hyperactivity caused by the antidepressants, which I thought was ridiculous, but it seemed to work for him, which is what matters). It's a complicated situation, one that can't be fixed by simply removing the medication altogether, or prescribing it to everyone with one or two symptoms of ADHD.

That said, counselling is *always* a better option - medication for these disorders should be a last-resort. I definitely agree with Smyth about kids that young on stimulants being reckless.
Click to expand...


yes u are right, some kids do have needs but i dont think amphetamines such as adderall are the solution, the increase in blood pressure and the stress on the heart and the whole circulatory system, do u really think kids under 10 really need this kinda stress on there bodies when at this age? i dont think so.

i def think there are alternatives such as counseling our maybe other medications
 
jond2005 said:
yes u are right, some kids do have needs but i dont think amphetamines such as adderall are the solution, these increase blood pressure and put stress on the heart and the whole circulatory system, do u really think kids under 10 really need this kinda stress on there bodies when at this age? i dont think so.

i def think there are alternatives such as counseling our maybe other medications
Click to expand...

Not to mention the fact that these stimulants are anorexiants as well, which can lead to abnormal development and poor growth in children.
 
ive known it was a problem since I was a kid and my cousin hated taking his meds, even told me it made him hate his life cuz it made it boring. it would real nice to start seeing some lawsuits, thats the only way changes are made nowadays unfortunately, and sometimes this doesnt even make a scratch
 
I think a lot of doctors are reckless with exactly how much of ritalin or dexamphetamine they're prescribing to these little kids. It's not only the age factor but also the amount. At the least they could advise people on supplements and vitamins to work against potential negative health effects of stimulant medication.

From my viewpoint the average person is far too trusting of their doctor, then again i suppose the average person is far too trusting of everything in our system.
 
^^ things may be quite different in your part of the world, but I don't agree.

I don't know any doctor who is enthousiastic about prescribing ritalin &c to young kids; the trouble is that a lot of parents put huge amounts of pressure on the doctor to prescribe it anyway.
 
How much as in the dosage they receive not as in number of kids they are wanting to prescribe it to
 
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