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Asthma drug Singulair linked to suicidal thoughts in young people
AN ASTHMA treatment used by 20,000 Australians has been linked to suicidal thoughts in teenagers and children and doctors are being urged to prescribe it with caution.
The nation's medicines watchdog has revealed it received 58 reports of adverse psychiatric events in children and teenagers being treated with Singulair between January 2000 and January 2013.
These included five reports of suicidal ideation, five reports of depression and eight reports of agitation, the Therapeutic Goods Administration says.
This could be an underestimate of the problem because the TGA says it is difficult to establish psychiatric diagnoses in children.
The watchdog's warning is included in its latest monthly medicines safety update which also reports other adverse reactions which link nightmares, altered mood and insomnia to the medicine.
''In many cases, patients experienced multiple neuropsychiatric reactions,'' the TGA says.
''Health professionals should be aware of these potential adverse effects and advise patients and parents to seek medical advice should they occur.
Asthma Australia medical expert Professor Adam Jaffe says Singulair is used more commonly in treating children than adults and is ''highly effective'' in the majority of cases.
''In a very small minority we do see behavioural side effects like nightmares and hyperactivity and in those children we have to stop it,'' he said.
''With any medication you have got to balance the risks versus the benefits and Singulair is no different,'' he said.
Professor Jaffe said it was his practice to talk to parents about the possible side effects because they usually went straight to the internet to research medicines prescribed for their children.
The drug company Merck includes warnings in its product information of possible side effects including suicidal ideation, depression, agitation, aggressive behaviour, hallucinations, insomnia, somnambulism and tremor,
Singulair was Merck's biggest selling drug earning around $5 billion a year worldwide until last year when its patent expired in the United States.
Cheaper generic versions of the drug are now available but not yet on the pharmaceutical benefits scheme in Australia.
The TGA wants doctors to carefully evaluate the risks and benefits of continuing treatment with Singulair if psychiatric events occur in a patient.
''In the case of children, caregivers should also be made aware of these potential adverse effects and instructed to seek medical advice if they have any concerns,'' the TGA says.
The US Food and Drug Administration investigated Singulair in 2009 and investigated the manufacturer's clinical trial reports on the drug and found psychiatric problems were not
frequently reported but noted the trials were not designed to look for the issue.
Read more: http://www.news.com.au/lifestyle/he...ts/story-fneuzlbd-1226615201114#ixzz2PuYDDW43
AN ASTHMA treatment used by 20,000 Australians has been linked to suicidal thoughts in teenagers and children and doctors are being urged to prescribe it with caution.
The nation's medicines watchdog has revealed it received 58 reports of adverse psychiatric events in children and teenagers being treated with Singulair between January 2000 and January 2013.
These included five reports of suicidal ideation, five reports of depression and eight reports of agitation, the Therapeutic Goods Administration says.
This could be an underestimate of the problem because the TGA says it is difficult to establish psychiatric diagnoses in children.
The watchdog's warning is included in its latest monthly medicines safety update which also reports other adverse reactions which link nightmares, altered mood and insomnia to the medicine.
''In many cases, patients experienced multiple neuropsychiatric reactions,'' the TGA says.
''Health professionals should be aware of these potential adverse effects and advise patients and parents to seek medical advice should they occur.
Asthma Australia medical expert Professor Adam Jaffe says Singulair is used more commonly in treating children than adults and is ''highly effective'' in the majority of cases.
''In a very small minority we do see behavioural side effects like nightmares and hyperactivity and in those children we have to stop it,'' he said.
''With any medication you have got to balance the risks versus the benefits and Singulair is no different,'' he said.
Professor Jaffe said it was his practice to talk to parents about the possible side effects because they usually went straight to the internet to research medicines prescribed for their children.
The drug company Merck includes warnings in its product information of possible side effects including suicidal ideation, depression, agitation, aggressive behaviour, hallucinations, insomnia, somnambulism and tremor,
Singulair was Merck's biggest selling drug earning around $5 billion a year worldwide until last year when its patent expired in the United States.
Cheaper generic versions of the drug are now available but not yet on the pharmaceutical benefits scheme in Australia.
The TGA wants doctors to carefully evaluate the risks and benefits of continuing treatment with Singulair if psychiatric events occur in a patient.
''In the case of children, caregivers should also be made aware of these potential adverse effects and instructed to seek medical advice if they have any concerns,'' the TGA says.
The US Food and Drug Administration investigated Singulair in 2009 and investigated the manufacturer's clinical trial reports on the drug and found psychiatric problems were not
frequently reported but noted the trials were not designed to look for the issue.
Read more: http://www.news.com.au/lifestyle/he...ts/story-fneuzlbd-1226615201114#ixzz2PuYDDW43
