Lecture 2: Over-the-Counter Medication and Herbal Supplements

Introduction

• Focus on over-the-counter (OTC) medications
• Controversy over herbal supplements, especially in the US

Kefauver-Harris Amendment (1962)

• Response to the FDA's inability to address the thalidomide event
• Thalidomide: Drug causing birth defects; FDA lacked power to stop its sale
• Amendment Features:
  • Manufacturers must prove drug effectiveness
  • Must publish side effects
  • Evidence based on controlled clinical trials by experts
  • FDA approval required before marketing
• Former FDA commissioner Margaret Hamburg emphasized FDA's enhanced power post-amendment

Over-the-Counter Medications

• Wide variety of OTC drugs available: antacids, antidiarrheal, sunscreen, cold remedies, analgesics, etc.
• Not all OTC drugs need tight oversight due to lower risk

Analgesics (Pain Relievers)

• Aspirin: Effective for dull pain, blocks prostaglandins
  • Risks: Stomach bleeding
  • Anticoagulant properties; useful during heart attacks
• Acetaminophen (Tylenol): Useful for pain and fever
  • Risks: Liver damage
• Ibuprofen (Motrin/Advil): Risks kidney issues
• Naproxen: Another common analgesic
• Marketing differences despite same active ingredients

Cold and Allergy Medications

• May contain decongestants, expectorants, antitussives, antihistamines
• Codeine in some prescription cold meds, not OTC
• Example: DayQuil contains acetaminophen

Stimulants and Sedatives

• Caffeine Pills: Available OTC
• Diphenhydramine: Often used in cold meds, causes drowsiness

Herbal Supplements

• Lack of FDA regulation unlike OTC medicines
• Manufacturers must ensure safety, but FDA acts only post-market
• Companies don't need to register with FDA
• Herbal supplements often accompanied by disclaimers about lack of FDA evaluation
• Common Supplements: Fish oil, St. John's Wort

Controversy and Legal Actions

• Example: Prevagen claims memory improvement but lacks FDA evaluation
• FTC lawsuits against misleading marketing
• Lack of stringent regulation for herbal supplements leads to potentially misleading claims

Risks and Misconceptions

• Herbal Supplements: Misleadingly perceived as safer than drugs
  • Example: Ephedra led to injuries and deaths
• Potential side effects and lack of evidence compared to OTC drugs
• Importance of cautious use due to lack of oversight

Conclusion

• Herbal supplements should be approached with care due to potential risks
• Next lecture will cover drug use statistics