Summary
All extracted vitamin B12-related claims are not supported by the provided FDA label excerpts (only dosing/administration and capsule swallowing instructions are present, with no vitamin B12 content).
Category Scores
Accurate Statements
Omeprazole delayed-release capsules should be taken before eating.
2 DOSAGE AND ADMINISTRATION: 'Omeprazole delayed-release capsules should be taken before eating.'
Omeprazole delayed-release capsules should be swallowed whole.
2 DOSAGE AND ADMINISTRATION: 'Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.'
For patients unable to swallow an intact capsule, capsule contents can be added to applesauce and swallowed immediately with cool water; pellets should not be chewed or crushed; mixture should not be stored.
17 PATIENT COUNSELING INFORMATION: 'For patients who have difficulty swallowing capsules, the contents... can be added to applesauce... pellets should not be chewed or crushed... mixture should not be stored for future use.'
Unsupported Statements
Omeprazole can reduce vitamin B12 absorption over time.
No vitamin B12 absorption/deficiency content is present in the provided label excerpts.
Omeprazole lowers stomach acid.
No label excerpt provided describes stomach acid effects.
Lower stomach acid helps release vitamin B12 from food proteins.
No vitamin B12 mechanism content is present in the provided label excerpts.
With less stomach acid, less vitamin B12 is absorbed.
No vitamin B12 absorption content is present in the provided label excerpts.
The reduction in vitamin B12 absorption is especially associated with long-term use of proton pump inhibitors (PPIs) like omeprazole.
No vitamin B12/PPI duration association content is present in the provided label excerpts.
Long-term PPI use is associated with lower vitamin B12 levels.
No vitamin B12 level content is present in the provided label excerpts.
In some people, chronic acid suppression from long-term PPI use is linked to vitamin B12 deficiency.
No vitamin B12 deficiency risk content is present in the provided label excerpts.
Risk for vitamin B12 deficiency from omeprazole is higher in older age.
No age-related vitamin B12 risk content is present in the provided label excerpts.
Risk for vitamin B12 deficiency from omeprazole is higher with low baseline vitamin B12 intake or borderline vitamin B12 levels.
No baseline/borderline vitamin B12 risk stratification content is present in the provided label excerpts.
Risk for vitamin B12 deficiency from omeprazole is higher in conditions that reduce stomach acid or intrinsic factor, such as atrophic gastritis.
No atrophic gastritis/intrinsic factor vitamin B12 risk content is present in the provided label excerpts.
Risk for vitamin B12 deficiency from omeprazole is higher with prolonged PPI use.
No duration/prolonged-use vitamin B12 risk content is present in the provided label excerpts.
Checking vitamin B12 is considered if a person has symptoms consistent with deficiency (fatigue, numbness/tingling, balance problems, or anemia) or if the person is on long-term PPI therapy.
No vitamin B12 evaluation/testing guidance is present in the provided label excerpts.
Vitamin B12 supplementation is considered if laboratory tests show low vitamin B12 or if a clinician judges the risk to be higher.
No vitamin B12 supplementation guidance is present in the provided label excerpts.
The effect of omeprazole on vitamin B12 levels is usually not immediate.
No time-course content for vitamin B12 effects is present in the provided label excerpts.
The main concern is sustained acid suppression over time.
No vitamin B12/sustained acid suppression concern content is present in the provided label excerpts.
People on long-term PPI therapy are more often evaluated for vitamin B12 status than those taking omeprazole for short courses.
No label excerpt provided includes comparative evaluation practices by duration.
Symptoms consistent with vitamin B12 deficiency include neurologic symptoms such as numbness/tingling and walking trouble.
No symptom-to-diagnosis counseling content for vitamin B12 is present in the provided label excerpts.
Symptoms consistent with vitamin B12 deficiency include signs of anemia such as unusual fatigue or shortness of breath.
No symptom-to-diagnosis counseling content for vitamin B12 is present in the provided label excerpts.
Discussing the lowest effective dose and whether ongoing PPI therapy is still necessary is a step to reduce risk in people using omeprazole long-term.
No dose minimization/ongoing therapy risk-reduction guidance for vitamin B12 is present in the provided label excerpts.
A vitamin B12 blood test may be appropriate for people taking omeprazole long-term depending on their situation.
No vitamin B12 testing recommendation content is present in the provided label excerpts.
Supplementation should be considered if vitamin B12 levels are low.
No vitamin B12 supplementation recommendation content is present in the provided label excerpts.
Contradictions
Important Omissions
No boxed warnings, warnings/precautions content, contraindications, drug interactions, adverse reactions, monitoring, or population-specific safety statements were provided in the excerpts; therefore the response cannot be assessed for label concordance in those areas (e.g., whether vitamin B12 is mentioned under warnings/precautions).
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Low
The audit is limited to label fidelity: the response introduces multiple vitamin B12 risk/evaluation/supplementation claims that are not supported by the provided label excerpts, which may mislead users relying on label-accurate content. No direct dosing/administration contradictions are present in the provided excerpts.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
High |
Recommendation
Not Aligned
Primary Issue
Vitamin B12 absorption/deficiency counseling and risk stratification claims are absent from the provided FDA label excerpts.
Suggested Improvement
Remove or replace all vitamin B12-related claims with statements directly supported by the full FDA-approved label text (including any vitamin B12 content, if present). Limit extracted administration instructions to those explicitly included in the label excerpts.