Excellent
Mostly Aligned
Patient Risk:
Low
Summary
The claim that promethazine (within Promethazine DM syrup) is contraindicated for pediatric patients <2 years due to potential/fatal respiratory depression, with caution for ages ≥2 years, is directly supported by the provided FDA label excerpts (Section 5 black box content and Section 2).
Category Scores
Accurate Statements
Promethazine should not be used in pediatric patients <2 years due to fatal respiratory depression.
Section 5: “PROMETHAZINE PRODUCTS ARE CONTRAINDICATED FOR USE IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF AGE.” and “RESPIRATORY DEPRESSION AND APNEA, SOMETIMES ASSOCIATED WITH DEATH…”; Section 2: contraindicated for children under 2 years.
With caution for pediatric patients 2 years and older due to potential for fatal respiratory depression.
Section 5: “CAUTION SHOULD BE EXERCISED… TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION.”
Unsupported Statements
Contradictions
Important Omissions
The claim does not specify that the label discusses association with death and that respiratory depression/apnea are strongly associated with promethazine products (and potentially with concomitant respiratory depressants).
Importance:
Low
Safety Assessment
Potential Patient Risk:
Low
The evaluated claim is a direct restatement of the label’s pediatric <2 years contraindication and ≥2 years caution related to fatal respiratory depression/apnea.
Regulatory Assessment
| On Label |
Yes |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Low |
Recommendation
Mostly Aligned
Primary Issue
Slightly reduced specificity: the claim does not include the label’s emphasis on association with death and/or concomitant respiratory depressants.
Suggested Improvement
Add that the label specifies contraindication for <2 years and caution for ≥2 years due to potential fatal respiratory depression/apnea, including that the risk is associated with death and respiratory depressants.