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Question about Singulair: side effects?
Carson has been on it for about 2.5 weeks.
I have heard/read that it can cause mood problems. I am going to call the pedi about it today. Anyone have any input?
TIA!
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Re: Question about Singulair: side effects?
I'm a former drug rep (not for this drug tho!)
Here's the verbage from the prescribing information:
5.4 Neuropsychiatric Events
Neuropsychiatric events have been reported in adult, adolescent, and pediatric patients taking
SINGULAIR. Post-marketing reports with SINGULAIR use include agitation, aggressive behavior or
hostility, anxiousness, depression, disorientation, dream abnormalities, hallucinations, insomnia,
irritability, restlessness, somnambulism, suicidal thinking and behavior (including suicide), and tremor.
The clinical details of some post-marketing reports involving SINGULAIR appear consistent with a drug-
induced effect.
Patients and prescribers should be alert for neuropsychiatric events. Patients should be instructed to
notify their prescriber if these changes occur. Prescribers should carefully evaluate the risks and benefits
of continuing treatment with SINGULAIR if such events occur [see Adverse Reactions (6.2)].
AND:
Pediatric Patients 2 to 5 Years of Age with Asthma
SINGULAIR has been evaluated for safety in 573 pediatric patients 2 to 5 years of age in single- and
multiple-dose studies. Cumulatively, 426 pediatric patients 2 to 5 years of age were treated with
SINGULAIR for at least 3 months, 230 for 6 months or longer, and 63 patients for one year or longer in
clinical trials. In pediatric patients 2 to 5 years of age receiving SINGULAIR, the following events occurred
with a frequency =2% and more frequently than in pediatric patients who received placebo: fever, cough,
abdominal pain, diarrhea, headache, rhinorrhea, sinusitis, otitis, influenza, rash, ear pain, gastroenteritis,
eczema, urticaria, varicella, pneumonia, dermatitis, and conjunctivitis.
Pediatric Patients 2 to 14 Years of Age with Seasonal Allergic Rhinitis
SINGULAIR has been evaluated in 280 pediatric patients 2 to 14 years of age in a 2-week,
multicenter, double-blind, placebo-controlled, parallel-group safety study. SINGULAIR administered once
daily in the evening had a safety profile similar to that of placebo. In this study, the following events
occurred with a frequency =2% and at an incidence greater than placebo: headache, otitis media,
pharyngitis, and upper respiratory infection.
and the 2 biggest neurological/psychiatric issues were headache and dizziness (1st set of #'s = singulair, 2nd set of #'s = placebo. The table didn't paste very pretty: The heavy duty stuff mentioned above didn't even make the adverse events chart so I'm thinking it's a VERY small portion of patients who will experience it.
TABLE 1
Adverse Experiences Occurring in =1% of Patients
with an Incidence Greater than that in Patients Treated with Placebo
SINGULAIR
10 mg/day
(%)
(n=1955)
Placebo
(%)
(n=1180)
Body As A Whole
Pain, abdominal
Asthenia/fatigue
Fever
Trauma
2.9
1.8
1.5
1.0
2.5
1.2
0.9
0.8
Digestive System Disorders
Dyspepsia
Pain, dental
Gastroenteritis, infectious
2.1
1.7
1.5
1.1
1.0
0.5
Nervous System/Psychiatric
Headache
Dizziness
18.4
1.9
18.1
1.4
Respiratory System Disorders
Influenza
Cough
Congestion, nasal
4.2
2.7
1.6
3.9
2.4
1.3
Skin/Skin Appendages Disorder
Rash
1.6
1.2
Laboratory Adverse Experiences*
ALT increased
AST increased
Pyuria
2.1
1.6
1.0
2.0
1.2
0.9
Total score: 6 pregnancies, 5 losses, 2 amazing blessings that I'm thankful for every single day.