Can pregnant patients take red yeast rice, which contains statins (HMG-CoA reductase inhibitors)?

Red Yeast Rice Should Not Be Used During Pregnancy

Red yeast rice supplements should be avoided during pregnancy due to their statin content (monacolin K) and potential risk to fetal development. 1, 2

Why Red Yeast Rice Is Contraindicated in Pregnancy

Red yeast rice contains monacolin K, which is chemically identical to the prescription statin lovastatin 2, 3. The concerns about red yeast rice in pregnancy are therefore the same as those for pharmaceutical statins:

• FDA guidance: Statins should generally be discontinued when pregnancy is recognized 1
• Mechanism of concern: Statins decrease synthesis of cholesterol and possibly other biologically active substances derived from cholesterol that may be important for fetal development 1
• Inconsistent product quality: Red yeast rice supplements have large variability in monacolin K content, making dosing unpredictable 3, 4
• Lack of regulation: The FDA does not adequately regulate manufacturers of red yeast rice products, raising concerns about quality control 4
• Additional toxins: Red yeast rice may contain citrinin and other mycotoxins that have not been adequately evaluated for safety 5

Current Guidelines on Statins in Pregnancy

The 2022 American College of Cardiology guidelines state that 6:

• Women who are currently on lipid-lowering drugs for primary prevention of ASCVD should discontinue pharmacologic therapy generally at least 1 month and preferably 3 months before attempted conception or immediately if already pregnant
• Statins are generally not recommended during pregnancy except in very specific high-risk situations

The 2025 American Diabetes Association guidelines similarly note 6:

• For most individuals, lipid-lowering medications should be stopped prior to pregnancy or at the first pregnancy visit
• Statins should be avoided in pregnancy in most circumstances
• Statins may only be considered in a shared decision-making process for pregnant individuals at high risk, such as those with a history of atherosclerotic cardiovascular disease or familial hypercholesterolemia

Exceptions to Consider

In extremely rare circumstances, statins might be considered during pregnancy:

• Patients with homozygous familial hypercholesterolemia
• Patients with established clinical atherosclerotic cardiovascular disease at very high risk
• In these cases, pharmaceutical statins (not red yeast rice) should be used under close medical supervision 6

Safety Concerns Specific to Red Yeast Rice

Red yeast rice supplements pose additional concerns beyond pharmaceutical statins:

• Unpredictable potency: Studies have found extensive variability in monacolin K content between products and even between batches 3
• Multiple monacolins: Different preparations contain varying types of monacolins beyond just monacolin K 3
• Adverse reactions: The Italian Surveillance System has documented numerous adverse reactions to red yeast rice supplements including myopathies and liver injury, similar to prescription statins 7
• Lack of standardization: Unlike prescription medications, there is no standardized preparation method for red yeast rice supplements 3

Management Recommendations

1. Discontinue red yeast rice immediately if pregnancy is recognized
2. Consider alternative approaches for managing cholesterol during pregnancy:
   • Lifestyle modifications including appropriate diet and physical activity
   • For high-risk patients who require lipid management during pregnancy, consult with a lipid specialist and maternal-fetal medicine specialist
3. Resume lipid-lowering therapy after completion of breastfeeding if indicated

Bottom Line

Red yeast rice supplements should not be used during pregnancy due to their statin content and potential risks to fetal development. The unpredictable potency, lack of standardization, and potential contamination with toxins make them particularly concerning compared to pharmaceutical statins, which themselves are generally contraindicated during pregnancy.