NMRA requires box warning and information for patient/care giver about serious mental health and side effects for asthma and allergy drug Montelukast to be included in the package insert (PIL) of the each and every commercial pack of Montelukast products -all oral dosage forms.
And,
Amended package insert/product information leaflet (PIL) need to be submitted to the NMRA within three months of this notice.
| RISK OF NEUROPSYCHIATRIC REACTIONS: Healthcare professionals are advised to be alert for neuropsychiatric reactions, including changes in behavior, speech impairment, depression and obsessive-compulsive symptoms, in adults, adolescents, and children taking montelukast. The risks and benefits of continuing treatment should be evaluated if these reactions occur. Patients should be advised to read the list of neuropsychiatric reactions in the product information leaflet and seek immediate medical attention if they occur. |
Information for the Patient/Care giver:
What should patients and parents/caregivers do?
Patients and parents/caregivers should stop montelukast and discuss with a health care professional right away if you or your child experience behaviour or mood-related changes while taking the medicine.
These may include:
- agitation, including aggressive behaviour or hostility
- attention problems
- bad or vivid dreams
- depression
- disorientation or confusion
- feeling anxious
- hallucinations (seeing or hearing things that are not really there)
- irritability
- memory problems
- obsessive-compulsive symptoms
- restlessness
- sleepwalking
- stuttering
- suicidal thoughts and actions
- tremor or shakiness
- trouble sleeping
- uncontrolled muscle movements