Positive health benefits? Harmful side effects? Problem: Not enough information

1. Herbal Supplements Chapter 15 • Positive health benefits? • Harmful side effects? • Problem: Not enough information

2. Herbals vs. Drugs • Are herbals approved by the FDA? • Do herbals require warning labels for potential side effects? • Can herbal manufacturers make claims without scientific evidence?

3. Herbals vs. Drugs • 1994 Dietary Supplement Health and Education Act • Labeling • Ingredients • Literature

4. Medications FDA approval Lab research Clinical trials Safety profile Herbals No FDA approval Lack of research Lack of quality control Testing and Approval

5. Medications Safety warnings Adverse effects Interactions Herbals No safety warnings No interactions with food, medications, or other herbs Potential allergic reactions Risks and Warnings

6. Medications Pure contents No contamination Exact quantities Herbals Contaminated ingredients i.e. Heavy metals, pesticides Lack of standardization Quality and Quantity

7. Medications Required by law Product-related adverse events Herbals Not required by law Reporting Adverse Events

8. Medications Highly regulated Based on scientific evidence Herbals Misleading Lack of research Statements & Claims

9. Herb Safety • Before taking an herbal supplement • Talk to your doctor • Ask questions!

10. Herb Safety • Don’t mix herbs and drugs • Results: • Ineffective medications • Harmful side effects

11. Herb Safety • High Risk Patients: • Elderly and children • Pregnant or breastfeeding • Chronically ill • Kidney disease • Taking prescription or OTC drugs

12. Herb Safety Combining similar actions Exceeding dosages Use national brands

13. Herb Safety Small amounts Limit time taken Single-herb products

14. Herb Safety Stop taking it if you experience adverse effects Contact your doctor FDA’s MedWatch hotline 1-800-FDA-1088

15. Top 6 Dangerous Herbs

16. Chaparral Dangers: Liver damage, liver failure, and death Regulatory Action: FDA Warning December 1992

17. Kava Dangers: High blood pressure, liver damage & death Regulatory Action: FDA Warning March 2002 Banned in Canada, Germany, Switzerland, Singapore, South Africa

18. Lobelia Dangers: Breathing difficulty, rapid heartbeat, low blood pressure, seizures, dizziness, tremors, coma & death Regulatory Action: Banned in Italy & Bangladesh

19. Yohimbe Dangers: Heart arrhythmias,  BP, heart attack, kidney damage, and death Regulatory Action: None

20. Comfrey Dangers: Liver damage, liver cancer, and death Regulatory Action: FDA Advisory July 2001

21. Ephedra Dangers: Seizures, stroke, cardiac arrest, death Regulatory Action: FDA Ban December 2003