ADHD drugs suspected of hurting Canadian kids

by David Bruser, Andrew Bailey
Staff Reporter, Data Analyst
thestar.com
September 26, 2012

Adverse Reaction Report No. 324764

Submitted by: Health Professional

Date: 2009

Location: Canada

Patient: Male

Age: 15 years old

Suspect Drug: Strattera

Side Effect: Completed Suicide

This is just one of nearly 600 cases of Canadian kids suffering serious, sometimes fatal side effects suspected to have been caused by ADHD medications in the past 10 years.

A Toronto Star investigation has found a growing number of doctors, nurses, pharmacists and parents are reporting that they believe attention deficit drugs are causing major health problems in patients, many as young as 6 and 7 years old.

The federal government is not listening.

Health Canada, which collects these adverse reaction reports, does not alert the public to the magnitude of these side effects. This is because the regulator has not analyzed the data it collects. It has allowed the industry to largely police itself.

“It is primarily the (drug company’s) responsibility to monitor the safe use of their products,” Health Canada told the Star.

The regulator says the benefits of the drugs, when properly prescribed and used, outweigh the risks. Health Canada and the drug companies also say the side-effect reports show only a suspected connection between the drug and side effect but no medical proof that one caused the other.

Though ADHD doctors and experts worry the Star’s investigation will scare parents from medicating kids in need, they say Health Canada should consider the reports a “red flag” and move quickly to find out if doctors and patients know enough about the drugs’ risks.

All parties involved agree that because doctors and nurses are not required by law to report adverse effects the regulator only learns of a minority of cases.

“It boils down to a simple thing: we need good safety monitoring for medication,” said Dr. Kenny Handelman, an ADHD specialist in Oakville. “That will help us be safer in prescribing medicines to people.”

The Star’s data analysis revealed 7-year-olds were most likely to suffer a serious side effect.

Ten per cent, or nearly 60 cases, of the nearly 600 reviewed involved boys and girls 7 years old.

A nurse said a boy suffered amnesia, mania and psychotic disorder while on Concerta. A 7-year-old girl on the same drug developed Stevens-Johnson syndrome, a potentially life-threatening skin disorder, as well as 13 other side effects, a doctor reported. A boy the same age and on Strattera thought about killing himself.

Twenty-two youths aged 8 to 18 tried to kill themselves and two demonstrated suicidal behaviour. Seven completed the attempt. All boys. An 11-year-old, one 14-year-old, two 13-year-olds and three 15-year-olds. One of the 15-year-olds who ended his life was on an antipsychotic that the reporting nurse believed was partly to blame.

The reports of the 11- and 14-year-old Canadian boys were found in the U.S. government side-effect database. Tuesday, Health Canada contested the accuracy of those reports and was continuing to look into the issue.

The Star also found four deaths that were not suicides, including an 18-year-old girl who died after a cerebral hemorrhage in 2011.

“This is ugly. This is really ugly,” said a concerned Conservative MP Terence Young, when presented with the Star’s findings. Young has been pushing for stricter regulation of the drug industry since his 15-year-old daughter Vanessa died while taking Prepulsid, a digestion aid, in 2000. Health Canada pulled the drug from shelves a few months after her death.

“Every parent who makes a decision about one of these ADHD drugs for their child should be given this information that the Star found on the adverse drug reactions that other children have suffered,” Young said.

Each of the nearly 600 adverse reaction reports reviewed by the Star is the opinion of the doctor, pharmacist or parent that a particular drug has caused a side effect. Anyone can make a report but most of the time it is doctors who do so. Patients’ names are taken out of the reports to protect their privacy.

The drugs in the Star study are commonly prescribed to help manage attention deficit hyperactivity disorder, a term used to describe people with poor focus, impulsivity and hyperactivity.

Though the number of Canadian kids with the disorder is unclear — one estimate puts it at one in 20 children — parents are increasingly turning to these drugs to deal with the diagnosis.

In the 10 years reviewed by the Star, 76 kids on ADHD medications thought about killing themselves. One-third of these were children younger than 10, some as young as 6.

When presented with this number, Dr. Sohail Khattak, a behavioural pediatrician and ADHD expert in Whitby, shook his head and said: “This is an important number. I think (this) information should be available to everyone. If I am going to be on the front line of prescribing the medication, I need to know.”

In 52 of these suicidal ideation reports, the attention deficit drug Strattera is listed as the suspected cause of the side effect. In 12 of the reports, Concerta is listed as the suspected cause. It is also listed as the suspected cause of one completed suicide.

Canadian doctors also prescribe Adderall XR (an extended-release formula), Ritalin, Vyvanse, Biphentin and generic versions to treat ADHD. Unlike other ADHD medications, Strattera is not a stimulant.

“Additional scientific investigations are needed to establish a cause and effect relationship between a medication and an adverse reaction,” said a spokesperson for Eli Lilly Canada, maker of Strattera.

The reports are supposed to play a crucial role in regulating the drug companies.

After a controlled-setting clinical trial involving thousands of participants, if a drug is approved for sale, the reports are often the only way a government can monitor how a drug performs in the much-larger general population. (A clinical trial may not reveal serious drug reactions that occur infrequently or take a long time to materialize.)

The Star found the reports are piling up in Ottawa at an increasing clip: more than one-third of the 600 serious ADHD medication side-effect reports were filed in the past two years alone.

While the reports accumulate, the Canadian regulator says on its website it does not have the expertise to analyze the information for trends and is relying on the U.S. Food and Drug Administration (FDA) for help. When asked about this in late August, the regulator told the Star that the plan to partner with the FDA had been dropped and another strategy would be launched this month.

In the meantime, the drug companies note that they are required by law to forward adverse reaction reports they receive to Health Canada, and say they closely monitor these reports and consider patient safety a priority.

[READ MORE…]

[hat tip: LittleSisMedia]