Poor
Not Aligned
Patient Risk:
Moderate
Summary
Mechanism-related claims about Lipitor are consistent with the label, but multiple broccoli–atorvastatin interaction claims (study/database/evidence and reassurance to not avoid broccoli) are not supported by the provided FDA labeling sections and therefore are misleading relative to the label.
Category Scores
Accurate Statements
Lipitor (atorvastatin) is a statin that inhibits the production of cholesterol in the liver.
12.1 Mechanism of Action / 12.2-12.3: HMG-CoA reductase inhibition and cholesterol synthesis inhibition in the liver (site of action).
Inhibiting cholesterol production in the liver reduces low-density lipoprotein (LDL) cholesterol in the blood.
12.1 Mechanism of Action: hepatic LDL receptor effects; LDL-C and lipoprotein reductions.
Unsupported Statements
A study found broccoli extract did not significantly affect the pharmacokinetics of atorvastatin (Lipitor) in healthy volunteers.
No broccoli-related study or PK data are present in the supplied label sections.
A study found broccoli consumption did not alter the plasma concentrations of atorvastatin in patients with hypercholesterolemia.
No broccoli-related study data are present in the supplied label sections.
According to a database, there are no reported interactions between broccoli and Lipitor.
The supplied label sections do not include any broccoli interaction database statement.
The available evidence suggests broccoli does not significantly affect the potency of Lipitor.
No broccoli-related evidence or potency claims are supported by the supplied label sections.
There is no need to avoid broccoli simply because of concerns about Lipitor.
The supplied label counseling is general (advising patients about substances not to take concomitantly) and does not mention broccoli; the specific reassurance about broccoli is not label-supported.
Contradictions
Important Omissions
Broccoli-specific interaction information (none provided) and any label-supported guidance regarding broccoli or related foods.
Importance:
High
Safety Assessment
Potential Patient Risk:
Moderate
Unsupported broccoli–atorvastatin interaction reassurances could mislead patients into assuming broccoli safety/concomitant safety is established by the labeling, despite the provided label sections not addressing broccoli.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
High |
Recommendation
Not Aligned
Primary Issue
Broccoli-specific study/database/evidence and the explicit reassurance to not avoid broccoli are unsupported by the provided FDA label sections.
Suggested Improvement
Remove broccoli-specific interaction/PK/potency claims and the reassurance statement; limit content to label-supported information (e.g., mechanism of action and label-discussed drug interaction classes).