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Chapter 15

Chapter 15. Over the Counter Drugs. 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.

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Chapter 15

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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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