Partial
Partially Aligned
Patient Risk:
Moderate
Summary
Some interaction statements align with the provided Lipitor label (notably CYP3A4 metabolism, CYP3A4 inhibitors, grapefruit juice effects, and cyclosporine). However, multiple herb- and symptom-specific claims (St. John's Wort, red yeast rice, grapefruit duration and quantitative ‘doubling’/dose thresholds) are not supported by the supplied label text, and several statements overgeneralize or overstate magnitudes.
Category Scores
Accurate Statements
Lipitor (atorvastatin) is metabolized by CYP3A4.
12.3 Pharmacokinetics: in vitro studies suggest metabolism by cytochrome P450 3A4; 7.1 Strong Inhibitors of CYP 3A4.
CYP3A4 inhibition can raise atorvastatin blood levels and increase the risk of muscle pain (myopathy) or rhabdomyolysis.
7.1 Strong Inhibitors of CYP 3A4: increases in plasma concentrations; 5.1 Skeletal Muscle: increased risk of myopathy/rhabdomyolysis with strong CYP3A4 inhibitors.
Grapefruit (juice or extract) inhibits CYP3A4, boosting atorvastatin levels.
7.2 Grapefruit Juice: inhibits CYP 3A4 and can increase plasma concentrations; 12.3 Pharmacokinetics Table 3.
Cyclosporine increases risk in patients taking Lipitor.
7.3 Cyclosporine: can increase bioavailability/AUC; 7 Drug Interactions and 5.1 Skeletal Muscle: increased risk with cyclosporine.
Unsupported Statements
St. John's Wort strongly induces CYP3A4, speeding atorvastatin breakdown.
Provided label text for CYP3A4 induction does not name St. John's Wort (7.4 references inducers generally, e.g., efavirenz/rifampin, but no St. John's Wort-specific statement in the supplied excerpts).
St. John's Wort reduces the cholesterol-lowering effect of atorvastatin.
No St. John's Wort-specific efficacy statement is supported by the supplied label excerpts.
Patients on Lipitor should avoid St. John's Wort to prevent treatment failure.
St. John's Wort is not identified in the supplied label excerpts.
The effect of grapefruit on atorvastatin exposure can last 24+ hours.
No duration statement regarding grapefruit effect is provided in the supplied label excerpts.
Red yeast rice contains natural lovastatin-like compounds.
Red yeast rice is not mentioned in the supplied label excerpts.
Combining red yeast rice with prescription statins raises the risk of myopathy.
Red yeast rice is not mentioned in the supplied label excerpts.
The FDA warns against using red yeast rice with prescription statins.
Red yeast rice is not mentioned in the supplied label excerpts; FDA-specific warning content about red yeast rice is not supported.
Inducers such as St. John's Wort decrease atorvastatin efficacy.
St. John's Wort-specific statement is not supported by supplied label excerpts.
Decreased atorvastatin efficacy can worsen cholesterol control and heart risk.
The provided label excerpts do not connect decreased efficacy to cholesterol control/heart risk.
Low body weight increases risk from herb-drug interactions with Lipitor.
No low body weight risk factor is included in the supplied label excerpts.
Hypothyroidism increases risk from herb-drug interactions with Lipitor.
No hypothyroidism risk factor is included in the supplied label excerpts.
Contradictions
Important Omissions
When discussing grapefruit, the label-supported quantity guidance in the supplied excerpts references excessive grapefruit consumption (>1.2 liters/day) rather than a specific 'under 1 quart/day' avoidance threshold.
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Moderate
Several unsupported or overstated counseling claims (St. John's Wort-specific interaction/avoidance and efficacy statements; red yeast rice content/FDA warning; grapefruit quantitative ‘doubling’ and duration) could mislead patient behavior. Some supported claims (grapefruit increases concentrations; strong CYP3A4 inhibitors increase myopathy/rhabdomyolysis risk; cyclosporine risk; age/renal risk context) reduce the overall miss severity.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Medium |
Recommendation
Partially Aligned
Primary Issue
Multiple herb-specific and quantitative/duration grapefruit claims are not supported by the provided Lipitor label excerpts, including St. John's Wort and red yeast rice.
Suggested Improvement
Limit herb-related statements to those explicitly supported in the supplied label excerpts (e.g., grapefruit juice >1.2 L/day; general CYP3A4 inducers like efavirenz/rifampin) and remove St. John's Wort/red yeast rice and unsupported grapefruit duration or 'doubling' magnitude claims; use label-supported thresholds where provided.