Clipping Board » Drug Poisoning ─ It is necessary to be aware of the toxic side effects before taking medication.
Seasonal changes are a high-risk period for asthma. According to the 2017 National Health Interview Survey by the Health Promotion Administration, the prevalence of asthma among children under 12 years old was 5.6%, and most of them were prescribed maintenance medications, with "Singulair" being one of them.
### Preventing Asthma Attacks
Asthma is a chronic inflammatory disease of the airways. During an attack, symptoms such as wheezing, difficulty breathing, chest tightness, and prolonged coughing may occur. Based on severity, asthma can be classified into four stages: mild intermittent, mild persistent, moderate persistent, and severe persistent. Regardless of the stage, acute attacks can occur.
Depending on the severity, asthma medications are divided into two main categories: acute relievers and maintenance controllers. Typically, except for patients with mild intermittent asthma (Stage 1), those in the other three stages of persistent asthma require daily use of maintenance control medications to manage chronic symptoms. Common maintenance medications include Montelukast (Singulair) and inhaled corticosteroids.
### FDA Warning: Singulair May Affect Behavior and Mood
Pediatrician Peddy shared on his social media page that the U.S. FDA issued a Black Box Warning for Montelukast (Singulair) on March 4, alerting doctors and patients to potential behavioral and mood-related side effects, such as depression, sleep disturbances, suicidal thoughts, and suicidal behavior.
The FDA has continuously received reports of mental health side effects linked to Singulair. Some occurred during treatment and resolved after discontinuation, while others reported persistent mental health issues even after stopping the medication.
A related study involving asthma patients aged 6 and above found that, compared to inhaled corticosteroids, Singulair indeed increased the risk of behavioral and mood changes.
Although there isn’t sufficient evidence to confirm a direct causal relationship between Singulair and mood disorders or suicide, considering the potential severity, the FDA stated, "Singulair is not recommended as a first-line treatment for allergic rhinitis." Alternative medications, such as antihistamines, steroid nasal sprays, or allergy shots, may be considered.
Dr. Peddy also mentioned in his post that if you have allergic rhinitis, you should avoid Singulair unless other allergy medications prove ineffective or you experience severe allergic reactions to other treatments.
If behavioral or mood changes occur after taking Singulair, discontinue use immediately and consult your doctor for further treatment options.
Source: https://news. sina. com. tw/ article/ 20200310/ 34479332. html
March 11, 2020 Executive Editor: Hovis
When it comes to Montelukast (Singulair), many parents might find the name familiar. Indeed! This pediatric medication is quite common in daily life. Some parents believe Montelukast can be used to "prevent allergies" or "treat coughs," making it a household staple.
However, not long ago, the U.S. FDA issued a drug safety warning for Montelukast, emphasizing that healthcare professionals should be aware of the risk of serious neuropsychiatric events associated with the drug, including depressive tendencies.
After the announcement, it caused quite a stir in parenting groups, with many moms spreading the news that "Montelukast has strong side effects," leading to widespread panic.
So, what exactly does this "drug warning" mean? Can children still take it? Today, we’ve invited a pharmacist to answer these questions for everyone.
**What is Montelukast (Singulair)?**
Montelukast is an anti-allergy medication. Most commonly used anti-allergy drugs on the market work by blocking histamines, but Montelukast operates through a different mechanism as a "leukotriene receptor antagonist," which is also highly effective.
Domestic prescribing information includes dosages for children over one year old, and the U.S. has also approved the drug for use in children as young as six months.
It is typically used for the prevention and long-term treatment of asthma, including preventing daytime and nighttime asthma symptoms, treating aspirin-sensitive asthma patients, and preventing exercise-induced bronchoconstriction. It can also be used to alleviate symptoms of allergic rhinitis.
Moreover, Montelukast is recommended in many clinical guidelines. In other countries, such as the U.S., its use is also very widespread. The recent black box warning caused such an uproar, which was actually expected.
**What does the FDA’s warning mean? Are the side effects really that severe?**
The content of the FDA’s warning is not complicated.
It mainly states: With the widespread use of this drug in the market, data on adverse reactions have become increasingly comprehensive. Over the past 20 years, reports of serious neuropsychiatric adverse reactions linked to this drug have continued to rise.
This isn’t the first time Montelukast has been flagged for side effects. Regulatory agencies in multiple countries have previously issued warnings about its neuropsychiatric risks:
- **July 12, 2018**: Australia’s TGA, based on known associations between Montelukast and psychiatric risks (such as agitation, sleep disturbances, and depression)—and in rare cases, suicidal thoughts and behaviors—implemented new risk management measures, recommending clear risk disclosures, warnings, and proactive counseling.
- **September 20, 2019**: The UK’s MHRA warned that Montelukast carries a risk of psychiatric reactions. Prescribers should monitor patients for such reactions and carefully weigh the benefits and risks of continued use if they occur.
- **September 27, 2019**: The FDA’s advisory committee held a joint meeting to review safety concerns regarding neurological events in children taking Montelukast for asthma and allergies.
This latest FDA warning primarily serves to remind healthcare professionals to take these adverse reactions seriously. As for the side effects parents are concerned about, they are documented in Montelukast’s prescribing information: after all, all medications come with potential side effects.No one can predict a drug's adverse reactions before they occur. After all, it takes years of clinical use, feedback, and data collection to compile more objective conclusions.
Over the years, there have been many studies on Singulair (Montelukast) and its neuro/psychiatric adverse reactions:
Although previous evidence has generally leaned toward the drug being safe, the authoritative guideline UpToDate still conservatively advises: "If a patient has pre-existing active anxiety, depression, or symptoms suggesting mental disorders, the use of Montelukast is not recommended."
Additionally, when prescribing this medication for the first time, it is recommended to inform all patients of this potential side effect and advise them to discontinue use if they notice adverse mood effects.
**Can children still take Singulair (Montelukast)?**
This time, it's just a drug safety warning—not severe enough to warrant immediate withdrawal from the market. Therefore, in some very specific cases, it can still be considered for use.
For example: patients with allergic rhinitis who have not responded to or cannot tolerate other anti-allergy medications. However, based on this warning, even in such cases, extra caution is required.
For asthma and allergic rhinitis, the first-line treatment is actually corticosteroids. Many parents choose Montelukast out of fear of "hormones."
In reality, no drug is 100% safe. While corticosteroids are first-line treatments, they are also the longest-used and safest option in clinical practice, deserving more trust. Moreover, corticosteroids are used in very low doses for asthma and allergic rhinitis, making them highly safe.
Thus, this drug warning serves as a reminder for parents, especially since this medication is widely used in our country. Although it is a prescription drug, it is available in most pharmacies, leading some parents to purchase it for their children without medical supervision, which may contribute to misuse.
**Asthma, allergic rhinitis, side effects, anti-allergy, medication safety**
**What should parents do if their child has taken or is currently taking this medication?**
As a parent whose child has used or is currently using this medication, the first step is to assess the child's current condition and ask a few questions:
1. How long has our child been taking it?
2. Have any related adverse reactions occurred?
3. How well have the symptoms been controlled after taking the medication?
If the child has only taken it occasionally in the past and showed no abnormalities, there’s no need to worry excessively.
If the child has been taking it for a while, shows no obvious abnormalities, and the treatment is effective, there’s also no need for excessive concern. However, it’s important to discuss with a doctor whether alternative medications are available, as this warning should not be ignored.
If there truly are no other effective treatment options, continued use is possible, but close monitoring is necessary. If related symptoms appear, the medication should be stopped promptly.
If after taking the medication, the child exhibits noticeable abnormalities—such as unexplained neuro/psychiatric symptoms, unusual behavior, nightmares, etc.—parents should proactively consult a doctor to consider discontinuing the medication and switching to another treatment.
Most adverse reactions will resolve on their own after stopping the medication, so parents need not be overly anxious. However, if the medication has not been very effective in the first place, there’s even less reason to continue using it, and discussing alternative treatments with a doctor is advisable.
Finally, it’s important to remember that medication use is always a process of weighing risks and benefits. We should approach this situation rationally and avoid unnecessary panic.As parents, what we can do is not to easily give children medication without authorization, nor to easily stop their medication without authorization.
Source: https://today. line. me/ tw/ v2/ article/ aooMM3
Asthma Drug Singulair Linked to Behavioral and Mood Effects: FDA Upgrades to Black Box Warning
### Preventing Asthma Attacks
Asthma is a chronic inflammatory disease of the airways. During an attack, symptoms such as wheezing, difficulty breathing, chest tightness, and prolonged coughing may occur. Based on severity, asthma can be classified into four stages: mild intermittent, mild persistent, moderate persistent, and severe persistent. Regardless of the stage, acute attacks can occur.
Depending on the severity, asthma medications are divided into two main categories: acute relievers and maintenance controllers. Typically, except for patients with mild intermittent asthma (Stage 1), those in the other three stages of persistent asthma require daily use of maintenance control medications to manage chronic symptoms. Common maintenance medications include Montelukast (Singulair) and inhaled corticosteroids.
### FDA Warning: Singulair May Affect Behavior and Mood
Pediatrician Peddy shared on his social media page that the U.S. FDA issued a Black Box Warning for Montelukast (Singulair) on March 4, alerting doctors and patients to potential behavioral and mood-related side effects, such as depression, sleep disturbances, suicidal thoughts, and suicidal behavior.
The FDA has continuously received reports of mental health side effects linked to Singulair. Some occurred during treatment and resolved after discontinuation, while others reported persistent mental health issues even after stopping the medication.
A related study involving asthma patients aged 6 and above found that, compared to inhaled corticosteroids, Singulair indeed increased the risk of behavioral and mood changes.
Although there isn’t sufficient evidence to confirm a direct causal relationship between Singulair and mood disorders or suicide, considering the potential severity, the FDA stated, "Singulair is not recommended as a first-line treatment for allergic rhinitis." Alternative medications, such as antihistamines, steroid nasal sprays, or allergy shots, may be considered.
Dr. Peddy also mentioned in his post that if you have allergic rhinitis, you should avoid Singulair unless other allergy medications prove ineffective or you experience severe allergic reactions to other treatments.
If behavioral or mood changes occur after taking Singulair, discontinue use immediately and consult your doctor for further treatment options.
Source: https://news. sina. com. tw/ article/ 20200310/ 34479332. html
FDA Warning: Mental Side Effects in Asthma Drug Singulair – is It Safe for Kids?
When it comes to Montelukast (Singulair), many parents might find the name familiar. Indeed! This pediatric medication is quite common in daily life. Some parents believe Montelukast can be used to "prevent allergies" or "treat coughs," making it a household staple.
However, not long ago, the U.S. FDA issued a drug safety warning for Montelukast, emphasizing that healthcare professionals should be aware of the risk of serious neuropsychiatric events associated with the drug, including depressive tendencies.
After the announcement, it caused quite a stir in parenting groups, with many moms spreading the news that "Montelukast has strong side effects," leading to widespread panic.
So, what exactly does this "drug warning" mean? Can children still take it? Today, we’ve invited a pharmacist to answer these questions for everyone.
**What is Montelukast (Singulair)?**
Montelukast is an anti-allergy medication. Most commonly used anti-allergy drugs on the market work by blocking histamines, but Montelukast operates through a different mechanism as a "leukotriene receptor antagonist," which is also highly effective.
Domestic prescribing information includes dosages for children over one year old, and the U.S. has also approved the drug for use in children as young as six months.
It is typically used for the prevention and long-term treatment of asthma, including preventing daytime and nighttime asthma symptoms, treating aspirin-sensitive asthma patients, and preventing exercise-induced bronchoconstriction. It can also be used to alleviate symptoms of allergic rhinitis.
Moreover, Montelukast is recommended in many clinical guidelines. In other countries, such as the U.S., its use is also very widespread. The recent black box warning caused such an uproar, which was actually expected.
**What does the FDA’s warning mean? Are the side effects really that severe?**
The content of the FDA’s warning is not complicated.
It mainly states: With the widespread use of this drug in the market, data on adverse reactions have become increasingly comprehensive. Over the past 20 years, reports of serious neuropsychiatric adverse reactions linked to this drug have continued to rise.
This isn’t the first time Montelukast has been flagged for side effects. Regulatory agencies in multiple countries have previously issued warnings about its neuropsychiatric risks:
- **July 12, 2018**: Australia’s TGA, based on known associations between Montelukast and psychiatric risks (such as agitation, sleep disturbances, and depression)—and in rare cases, suicidal thoughts and behaviors—implemented new risk management measures, recommending clear risk disclosures, warnings, and proactive counseling.
- **September 20, 2019**: The UK’s MHRA warned that Montelukast carries a risk of psychiatric reactions. Prescribers should monitor patients for such reactions and carefully weigh the benefits and risks of continued use if they occur.
- **September 27, 2019**: The FDA’s advisory committee held a joint meeting to review safety concerns regarding neurological events in children taking Montelukast for asthma and allergies.
This latest FDA warning primarily serves to remind healthcare professionals to take these adverse reactions seriously. As for the side effects parents are concerned about, they are documented in Montelukast’s prescribing information: after all, all medications come with potential side effects.No one can predict a drug's adverse reactions before they occur. After all, it takes years of clinical use, feedback, and data collection to compile more objective conclusions.
Over the years, there have been many studies on Singulair (Montelukast) and its neuro/psychiatric adverse reactions:
Although previous evidence has generally leaned toward the drug being safe, the authoritative guideline UpToDate still conservatively advises: "If a patient has pre-existing active anxiety, depression, or symptoms suggesting mental disorders, the use of Montelukast is not recommended."
Additionally, when prescribing this medication for the first time, it is recommended to inform all patients of this potential side effect and advise them to discontinue use if they notice adverse mood effects.
**Can children still take Singulair (Montelukast)?**
This time, it's just a drug safety warning—not severe enough to warrant immediate withdrawal from the market. Therefore, in some very specific cases, it can still be considered for use.
For example: patients with allergic rhinitis who have not responded to or cannot tolerate other anti-allergy medications. However, based on this warning, even in such cases, extra caution is required.
For asthma and allergic rhinitis, the first-line treatment is actually corticosteroids. Many parents choose Montelukast out of fear of "hormones."
In reality, no drug is 100% safe. While corticosteroids are first-line treatments, they are also the longest-used and safest option in clinical practice, deserving more trust. Moreover, corticosteroids are used in very low doses for asthma and allergic rhinitis, making them highly safe.
Thus, this drug warning serves as a reminder for parents, especially since this medication is widely used in our country. Although it is a prescription drug, it is available in most pharmacies, leading some parents to purchase it for their children without medical supervision, which may contribute to misuse.
**Asthma, allergic rhinitis, side effects, anti-allergy, medication safety**
**What should parents do if their child has taken or is currently taking this medication?**
As a parent whose child has used or is currently using this medication, the first step is to assess the child's current condition and ask a few questions:
1. How long has our child been taking it?
2. Have any related adverse reactions occurred?
3. How well have the symptoms been controlled after taking the medication?
If the child has only taken it occasionally in the past and showed no abnormalities, there’s no need to worry excessively.
If the child has been taking it for a while, shows no obvious abnormalities, and the treatment is effective, there’s also no need for excessive concern. However, it’s important to discuss with a doctor whether alternative medications are available, as this warning should not be ignored.
If there truly are no other effective treatment options, continued use is possible, but close monitoring is necessary. If related symptoms appear, the medication should be stopped promptly.
If after taking the medication, the child exhibits noticeable abnormalities—such as unexplained neuro/psychiatric symptoms, unusual behavior, nightmares, etc.—parents should proactively consult a doctor to consider discontinuing the medication and switching to another treatment.
Most adverse reactions will resolve on their own after stopping the medication, so parents need not be overly anxious. However, if the medication has not been very effective in the first place, there’s even less reason to continue using it, and discussing alternative treatments with a doctor is advisable.
Finally, it’s important to remember that medication use is always a process of weighing risks and benefits. We should approach this situation rationally and avoid unnecessary panic.As parents, what we can do is not to easily give children medication without authorization, nor to easily stop their medication without authorization.
Source: https://today. line. me/ tw/ v2/ article/ aooMM3