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Understanding Over-the-Counter Drugs: FDA Regulations and Safety Insights

Chapter 15 focuses on over-the-counter (OTC) drugs and the FDA's regulatory framework, particularly following the 1962 Kefauver-Harris Amendment. It discusses the concepts of Generally Recognized as Safe (GRAS) and Generally Recognized as Effective (GRAE), highlighting the similarities between OTC and prescription drugs, differences in active ingredient concentrations, and the emergence of certain products that have transitioned from prescription to OTC availability. Key topics include psychoactive OTC products, analgesics like aspirin and acetaminophen, and herbal alternatives.

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Understanding Over-the-Counter Drugs: FDA Regulations and Safety Insights

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  1. Chapter 15 Over the Counter Drugs

  2. FDA Regulations • 1962 Kefauver-Harris Amendment required drugs to be safe and effective • GRAS (generally recognized as safe) • GRAE (generally recognized as effective) • Results in all competing brands contain much of the same ingredients = identical

  3. OTC vs. Prescription • Only difference is the prescription product has greater amounts of active ingredient • Prescription drugs are chemicals that are unavailable OTC • Over time, the FDA allows certain preparations with higher doses to be sold OTC • This allows more frequency of prescription products to become OTC based on revised New Drug Applications (NDA’s)

  4. Psychoactive OTC Products • Stimulants • Phenylpropanolamine (PPA) are combined caffeine and ephedrine that are illegal OTC products • Ephedrine is now under close scrutiny by the FDA • Weight control products • PPA’s were used for this until November 2000 • Sedative and sleep aids • Antihistamines usage • Analgesics (pain relievers)

  5. Aspirin • Salicylates (internal analgesics) • 2,400 years ago Greeks used willow bark (salix) to treat illnesses • 1890’s Bayer Laboratories, Herr Hoffmann synthesized acetylsalicylic acid (aspirin) • This reduced side effects that salicylates caused

  6. Therapeutic Uses of Aspirin • Antipyretic (decreases fever) • Anti-inflammatory agent (decreases swelling) • Blocks pain

  7. Adverse Effects of Aspirin • Inhibits blood clotting • Fetal injury during 3rd trimester • Induces gastrointestinal tract bleeding • Reye’s Syndrome

  8. Acetaminophen • Equipotent with aspirin in the analgesic and antipyretic effects • Not an anti-inflammatory • Examples are Tylenol and Dantril • Overuse causes serious liver disorders

  9. Ibuprofen andOther NSAID’s • Former prescription analgesic • Anti-inflammatory value • Doses have common side effects • Other non-steroidol anti-inflammatory drugs are now available OTC

  10. Cold and Allergy Products • 3 common ingredients found in cold remedies • Anti-histamines • Nasal decongestants • Analgesic-antipyretics • Table 15-2 shows common formulations of popular remedies

  11. Popular Herbal Products • St. John’s Wort (hypericum perforatum) • SAMe (S-adenosyl-L-methionine) • Ginkgo biloba

  12. Chapter 15 Over the Counter Drugs

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