Dark side of a wonder drug

March 28, 2006

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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