Legal requirement for strong warning about risk of Singulair and generic Montelukast


Legal requirement for strong warning about risk of Singulair and generic Montelukast
The Issue
There is increasing evidence that the asthma and allergy medication Singulair and the generic medication Montelukast can lead to neuropsychiatric events in children. The FDA in the US now requires stronger warning about this risk but this medication, which is widely prescribed by doctors in Singapore, is severely lacking in such warning here. Some doctors are even marketing it as tonic for the lungs with claims that it is extremely safe for children.
Starting 11 August 2020, my 11 year old daughter has been displaying the Singulair withdrawal syndrome - extreme anxieties, fears, worries, withdrawn, difficulty sleeping and hallucinations.
She had taken Singulair since July 2018 after her dad’s respiratory specialist Dr CT Y based at Gleneagles diagnosed her with asthma. It did help with the asthma but this year, I noticed she got worried and sad easily and the first specialist refused to take her off it and kept saying it was safe. At that time, a friend told me about the danger of Singulair associated with depression. So I switched her to a pediatric respiratory specialist in June and the specialist said my girl should not been on it for so long and at such dosage. Then we realised that the first specialist whom we trustEd had given her the adult dosage of 10mg when children her age should only be prescribed 5 mg. We took her off it immediately but I did not know about the withdrawal syndrome. The pediatric specialist had not encountered that before as none of her pediatric patients had taken such high dosage for so long. Following the onset of her withdrawal syndrome, the pediatric specialist and the pediatric neurologist warded her to run a health check and neurological tests and thank God for the miracle that the results including the brain MRI are normal. After ruling out the possible medical causes, the pediatric respiratory specialist agrees that the Singulair withdrawal syndrome is a likely cause for her current condition but unfortunately there is no test to prove it.
With the encouragement and support of family, friends and teachers, together with counselling and a detox program, my daughter is slowly recovering.
Since then, I have spoken to many friends and many have encountered neuropsychiatric events associated with Singulair usage for their children, even though their children had taken it for brief period only.
Hence I want to ask the Health Sciences Authority to take immediate actions to protect all children from being exposed to the neuropsychiatric risk associated with Singulair and Montelukast by:
(1) Making it compulsory for the manufacturer to label this risk on all Singulair and Montelukast medication boxes.
(2) Making it compulsory for all doctors to highlight this risk clearly to the patients or their guardians before any prescription.
(3) Reviewing the clinical protocol for the prescription of this drug : Maximum dosage for children, maximum period for taking the drug, the strict medical conditions under which this drug may be prescribed with strict follow up and review protocols.
(4) Working with MOH to review the doctor’s’ professional ethics with regards to drug prescriptions to prevent any unscrupulous doctors from placing profit-making above the well-being of the patients.

The Issue
There is increasing evidence that the asthma and allergy medication Singulair and the generic medication Montelukast can lead to neuropsychiatric events in children. The FDA in the US now requires stronger warning about this risk but this medication, which is widely prescribed by doctors in Singapore, is severely lacking in such warning here. Some doctors are even marketing it as tonic for the lungs with claims that it is extremely safe for children.
Starting 11 August 2020, my 11 year old daughter has been displaying the Singulair withdrawal syndrome - extreme anxieties, fears, worries, withdrawn, difficulty sleeping and hallucinations.
She had taken Singulair since July 2018 after her dad’s respiratory specialist Dr CT Y based at Gleneagles diagnosed her with asthma. It did help with the asthma but this year, I noticed she got worried and sad easily and the first specialist refused to take her off it and kept saying it was safe. At that time, a friend told me about the danger of Singulair associated with depression. So I switched her to a pediatric respiratory specialist in June and the specialist said my girl should not been on it for so long and at such dosage. Then we realised that the first specialist whom we trustEd had given her the adult dosage of 10mg when children her age should only be prescribed 5 mg. We took her off it immediately but I did not know about the withdrawal syndrome. The pediatric specialist had not encountered that before as none of her pediatric patients had taken such high dosage for so long. Following the onset of her withdrawal syndrome, the pediatric specialist and the pediatric neurologist warded her to run a health check and neurological tests and thank God for the miracle that the results including the brain MRI are normal. After ruling out the possible medical causes, the pediatric respiratory specialist agrees that the Singulair withdrawal syndrome is a likely cause for her current condition but unfortunately there is no test to prove it.
With the encouragement and support of family, friends and teachers, together with counselling and a detox program, my daughter is slowly recovering.
Since then, I have spoken to many friends and many have encountered neuropsychiatric events associated with Singulair usage for their children, even though their children had taken it for brief period only.
Hence I want to ask the Health Sciences Authority to take immediate actions to protect all children from being exposed to the neuropsychiatric risk associated with Singulair and Montelukast by:
(1) Making it compulsory for the manufacturer to label this risk on all Singulair and Montelukast medication boxes.
(2) Making it compulsory for all doctors to highlight this risk clearly to the patients or their guardians before any prescription.
(3) Reviewing the clinical protocol for the prescription of this drug : Maximum dosage for children, maximum period for taking the drug, the strict medical conditions under which this drug may be prescribed with strict follow up and review protocols.
(4) Working with MOH to review the doctor’s’ professional ethics with regards to drug prescriptions to prevent any unscrupulous doctors from placing profit-making above the well-being of the patients.

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Petition created on 22 August 2020