WHATFG
Well-Known Member
Prompted by reports of suicidal behaviour in patients taking ADHD medications, Health Canada is issuing “stronger, clearer warnings” about the risks associated with the drugs.
The drugs are: Adderall XR, Concerta, Biphentin, Strattera, Intuniv XR, Dexedrine, Ritalin, Ritalin SR, and Vyvanse. They are prescribed to help manage attention deficit hyperactivity disorder, a term used to describe people with poor focus, impulsivity and hyperactivity.
Health Canada said that, overall, the benefits of these drugs in ADHD treatment continue to outweigh the risks.
The regulator made the announcement Monday after reviewing reports of suspected side-effects filed to the federal government. Such reports are typically made by doctors, nurses, patients and drug companies.
“The reports involved thoughts of suicide, suicide attempts, and in a very small number of cases, completed suicide,” Health Canada said in a statement. “These events have been reported at various times during treatment, particularly at the start or during dose changes, and also after stopping the drug treatment.”
This is the same type of data reviewed by the Star as part of its 2012 investigation that found nearly 600 cases of Canadian kids suffering serious, sometimes fatal side-effects suspected to have been caused by ADHD medications between 2002 and 2012. (Intuniv XR was not on the market then.)
In the ensuing years, Health Canada has received more reports, but the regulator was not immediately able to offer specifics of any that may have led to its decision.
The side-effect reports show only a suspected connection between the drug and side-effect but no medical proof that one caused the other.
In its Monday press release, Health Canada underscored that point, saying, “There is little evidence to establish that these drugs cause suicidal thoughts and behaviours, but it is possible that they may contribute to the risk.”
The Star’s 2012 investigation found in these suspected side-effect reports, which are filed in a federal database, that 76 kids on ADHD medications thought about killing themselves. One-third of these were children younger than 10; some were as young as 6.
In addition, the Star found that 22 Canadian youths aged 8 to 18 tried to kill themselves. Five completed the attempt. All were boys age 13 to 15.
It has been estimated that one in 20 Canadian children have ADHD.
Doctors who specialize in ADHD and other experts told the Star in 2012 that, while they worried the newspaper’s investigation would scare parents from medicating kids in need, 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.
The risk of suicidal behaviour was flagged for one of the drugs, Strattera, in 2005, but “new information has emerged since to suggest that the risks . . . may apply to all other ADHD drugs,” Health Canada said Monday.
Whitby doctor Sohail Khattak was surprised to see the regulator’s announcement covered all of the ADHD drugs.
“The wow element is: Why now? What specific additional information does Health Canada have on every medication that is being prescribed for ADHD?”
The regulator also published Monday brief summaries of recent safety reviews it conducted into ADHD medications containing amphetamines, such as Dexedrine and Adderall XR, and methylphenidate, including Concerta and Ritalin. Both kinds of drugs are commonly prescribed to Canadian children.
The reviews were prompted by side-effects reports sent to the regulator describing suicidal behaviour after a patient took ADHD medication.
“Side-effects are things that need to be monitored,” said Heidi Bernhardt, president and executive director of the Centre for ADHD Awareness Canada, an ADHD advocacy group. “It’s always a good thing to notify the public and medical professionals about this stuff as soon as there is some evidence that’s found that hasn’t been there. Is it something to panic about? No.”
The stronger warnings will apply to generic and brand-name ADHD drugs. Shire Canada, whose Vyvanse, Adderall XR and Intuniv XR were all listed in Health Canada’s announcement, did not immediately respond to questions from the Star.
Janssen, which manufactures Concerta, said a recent company review “did not identify evidence of a causal relationship between Concerta and suicide.”
Health Canada also notes in its Monday press release that people with ADHD “may already have a slightly increased risk of suicidal thoughts and behaviours,” and that “ADHD may also affect people who have other mental health conditions that are associated with an increased risk of suicide, such as depression or bipolar disorder.”
Khattak, who had concerns in 2012 that doctors were possibly over-prescribing ADHD medications, said the new warning language highlights the importance of health professionals carefully diagnosing a child whose ADHD symptoms may be the result of depression or anxiety.
The drugs are: Adderall XR, Concerta, Biphentin, Strattera, Intuniv XR, Dexedrine, Ritalin, Ritalin SR, and Vyvanse. They are prescribed to help manage attention deficit hyperactivity disorder, a term used to describe people with poor focus, impulsivity and hyperactivity.
Health Canada said that, overall, the benefits of these drugs in ADHD treatment continue to outweigh the risks.
The regulator made the announcement Monday after reviewing reports of suspected side-effects filed to the federal government. Such reports are typically made by doctors, nurses, patients and drug companies.
“The reports involved thoughts of suicide, suicide attempts, and in a very small number of cases, completed suicide,” Health Canada said in a statement. “These events have been reported at various times during treatment, particularly at the start or during dose changes, and also after stopping the drug treatment.”
This is the same type of data reviewed by the Star as part of its 2012 investigation that found nearly 600 cases of Canadian kids suffering serious, sometimes fatal side-effects suspected to have been caused by ADHD medications between 2002 and 2012. (Intuniv XR was not on the market then.)
In the ensuing years, Health Canada has received more reports, but the regulator was not immediately able to offer specifics of any that may have led to its decision.
The side-effect reports show only a suspected connection between the drug and side-effect but no medical proof that one caused the other.
In its Monday press release, Health Canada underscored that point, saying, “There is little evidence to establish that these drugs cause suicidal thoughts and behaviours, but it is possible that they may contribute to the risk.”
The Star’s 2012 investigation found in these suspected side-effect reports, which are filed in a federal database, that 76 kids on ADHD medications thought about killing themselves. One-third of these were children younger than 10; some were as young as 6.
In addition, the Star found that 22 Canadian youths aged 8 to 18 tried to kill themselves. Five completed the attempt. All were boys age 13 to 15.
It has been estimated that one in 20 Canadian children have ADHD.
Doctors who specialize in ADHD and other experts told the Star in 2012 that, while they worried the newspaper’s investigation would scare parents from medicating kids in need, 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.
The risk of suicidal behaviour was flagged for one of the drugs, Strattera, in 2005, but “new information has emerged since to suggest that the risks . . . may apply to all other ADHD drugs,” Health Canada said Monday.
Whitby doctor Sohail Khattak was surprised to see the regulator’s announcement covered all of the ADHD drugs.
“The wow element is: Why now? What specific additional information does Health Canada have on every medication that is being prescribed for ADHD?”
The regulator also published Monday brief summaries of recent safety reviews it conducted into ADHD medications containing amphetamines, such as Dexedrine and Adderall XR, and methylphenidate, including Concerta and Ritalin. Both kinds of drugs are commonly prescribed to Canadian children.
The reviews were prompted by side-effects reports sent to the regulator describing suicidal behaviour after a patient took ADHD medication.
“Side-effects are things that need to be monitored,” said Heidi Bernhardt, president and executive director of the Centre for ADHD Awareness Canada, an ADHD advocacy group. “It’s always a good thing to notify the public and medical professionals about this stuff as soon as there is some evidence that’s found that hasn’t been there. Is it something to panic about? No.”
The stronger warnings will apply to generic and brand-name ADHD drugs. Shire Canada, whose Vyvanse, Adderall XR and Intuniv XR were all listed in Health Canada’s announcement, did not immediately respond to questions from the Star.
Janssen, which manufactures Concerta, said a recent company review “did not identify evidence of a causal relationship between Concerta and suicide.”
Health Canada also notes in its Monday press release that people with ADHD “may already have a slightly increased risk of suicidal thoughts and behaviours,” and that “ADHD may also affect people who have other mental health conditions that are associated with an increased risk of suicide, such as depression or bipolar disorder.”
Khattak, who had concerns in 2012 that doctors were possibly over-prescribing ADHD medications, said the new warning language highlights the importance of health professionals carefully diagnosing a child whose ADHD symptoms may be the result of depression or anxiety.
