Drugs & Society Over-the-Counter Medications

1. Chapter 14
Over-the-Counter
Drugs
Albia Dugger • Miami Dade College

2. OTC Drug Market
• Billions of dollars are spent each year on OTC drugs
• In the US, four out of five adults take medicine or
supplements on a weekly basis
• The perception that nonprescription drugs (OTCs) are
completely safe can have grave consequences

3. OTC Drug Market
• For many years, people could get OTC drugs (patent
medicines) from traveling shows or from a local pharmacist
or physician
• The contents of these drugs were not regulated
• The Pure Food and Drug Act (1906) stipulated that
ingredients had to be listed on labels

4. Regulating OTC Drugs
• The Food, Drug, and Cosmetic Act (1938) required that
prescription drugs be proved safe and effective before being
marketed
• The Kefauver-Harris Amendment (1962) required that
nonprescription (OTC) drugs be proved safe and effective
• The FDA evaluated ingredients in OTC drugs rather than
examining each product

5. Regulating OTC Drugs
• In 2007, the FDA proposed a category for “behind-the-counter”
(BTC) drugs which consumers would have to ask for
after consultation with their pharmacist
• The Combat Methamphetamine Epidemic Act (2005) banned
OTC cold medicines containing pseudoephedrine, an
ingredient used to make methamphetamine

6. Children at risk for
adverse reactions to OTC drugs

7. Generic Versus Brand Name Drugs
• Generic drugs are copies of brand name drugs and have the
same dosage, safety, strength, and quality
• One advantage of generic drugs is that they cost less
• Trademark laws in the United States require that generic
drugs not look exactly like brand name drugs

8. Categories of OTC Drugs
• Category I:
• “generally recognized as safe” (GRAS)
• “generally recognized as effective” (GRAE)
• “generally recognized as honestly labeled” (GRAHL)
• Category II: Not generally recognized as safe or effective or is
improperly labeled
• Category III: Cannot be sold

9. Herbal Drugs
• Herbal drugs are largely unregulated
• It is unclear whether they should be classified as drugs, foods,
or herbs
• Manufacturers of herbal drugs cannot make claims regarding
their benefits without proof
• Some herbal remedies can interfere with the effectiveness of
conventional drugs

10. Commonly Used Herbal Supplements

11. Analgesics (Pain Killers)
• Two basic types of analgesics:
• External analgesics, such as Ben-Gay and Absorbine,
applied to the skin for sore muscles
• Internal analgesics such as aspirin, acetaminophen,
ibuprofen, naproxen sodium, and ketoprofen
• In 2009, 53,000 people went to emergency rooms due to
acetaminophen, and 27,000 people went to emergency rooms
due to ibuprofen

12. ASPIRIN
• Aspirin (acetylsalicylic acid)
• Similar to a chemical in willow bark
• Developed by Bayer
• Alters synthesis of prostaglandins
• Reduces inflammation, especially rheumatoid arthritis
• Antipyretic (fever-reducing)
• Reduces risk of heart attack and several diseases
• Increases bleeding risk
• Inhibits interferon
• Avoid use by children

13. Aspirin and Children
• Children with chicken
pox or flu-like symptoms
should not be given
aspirin

14. Acetaminophen
• Acetaminophen (Tylenol)
• Byproduct of phenacetin
• Reduces pain and fever
• Interferes with prostaglandin synthesis
• Adverse effects on liver and kidneys
• Irritates stomach less than aspirin
• Does not prolong bleeding
• Can cause death

15. Ibuprofen
• Ibuprofen (Advil)
• Reduces pain
• Lessens inflammation
• Produces less stomach upset
• May reduce risk of breast cancer and Alzheimer’s
• Prolongs bleeding time
• Can cause allergic reaction
• Numerous side effects
• May increase risk of peptic ulcers and enlarged prostate
• Can cause death

16. Naproxen Sodium and Ketoprofen
• Naproxen sodium (Aleve)
• Comparable to ibuprofen in effectiveness
• Long-term pain relief
• Ketoprofen (Orudis KT and Actron)
• Effective as ibuprofen
• More effective than acetaminophen for reducing fever in
children

17. Cold and Allergy Drugs
• OTC drugs relieve symptoms of colds and allergies
• Many people overcome colds more quickly when physicians
prescribe medications, even placebos
• Cough and cold remedies for children can be hazardous

18. The best way to prevent colds

19. Antihistamines
• When allergens are present, the body releases histamines
that normally help fight infections
• Antihistamines are effective for relieving itching, nasal
inflammation, and skin allergies
• Antihistamines are found in cough syrups, hay fever and
motion sickness preparations, and decongestants

20. Side Effects of Antihistamines
• Dizziness
• Weakness
• Nervousness
• Poor concentration
• Headache
• Drowsiness
• Blurred vision
• Difficulty urinating
• Constipation
• Hives
• Dry mouth, nose, and
throat

21. Cough Medicines
• A cough can be productive (produce secretions) or
nonproductive
• Drugs that suppress or prevent coughing are antitussives
• Codeine provides relief within 15 to 30 minutes, and the
effects last 4 to 6 hours
• Dextromethorphan (Delsym) is nonnarcotic , but can induce
drowsiness, nausea, and dizziness

22. Cough Medicines
• A productive cough helps respiration by removing mucous
secretions and foreign matter
• Cough syrups that increase mucous secretions, making a
cough productive, are called expectorants
• The most common expectorant is guaifenesin

23. Decongestants
• Decongestants constrict blood vessels of the nasal
passages, improve air flow, and obstruct secretions
• Some produce a rebound effect, in which the congestion
becomes worse than it was originally
• Dependency is possible – nasal sprays should not be used for
more than three consecutive days
• Pseudoephedrine is the active ingredient in the OTC
decongestant Sudafed

24. Antacids
• Neutralize stomach acid (hydrochloric acidr) reducing the
symptoms of the upset stomach
• OTC products contain such drugs as:
• Sodium bicarbonate
• Calcium carbonate
• Salts of magnesium
• Salts of aluminum
• Product examples include:
• Tums, Rolaids, Alka Seltzer

25. Drawbacks of Antacids

26. H2 Blockers and PPIs
• Newer heartburn remedies include histamine (H2) blockers
and proton pump inhibitors (PPIs)
• H2 blockers (Tagamet HB and Zantac) are effective in less
severe cases
• The American College of Gastroenterology recommends PPIs
(Prilosec and Nexium) because they are more effective

27. Sleep Aids and Sedatives
• The primary ingredient in many OTC sedatives and sleep aids
is some type of antihistamine
• A person should not drive an automobile, drink alcohol, or
engage in potentially hazardous activities while taking
antihistamines
• Examples include Nytol, Sominex, and Seep-Eze

28. OTC Stimulants
• The primary ingredient in OTC stimulants is caffeine
• Does not reverse alcohol intoxication
• Examples include Vivarin, No Doz, and “energy drinks” and
inhalable forms of caffeine
• Excessive caffeine consumption (caffeinism) results in
nervousness, anxiety, tachycardia, sweating, and panic

29. Weight Loss Aids
• Ephedrine (ephedra) can be fatal when combined with other
stimulants such as caffeine
• Orlistat (alli) works by blocking the absorption of about 25%
of the fat in the foods that people consume
• Phenylpropanolamine (PPA) is an appetite suppressant,
structurally similar to amphetamines
• Benzocaine is a topical anesthetic that numbs the tongue
and palate

30. Being a Smart Consumer
• Consumers must look at advertisements for OTC drugs
carefully because they may give inaccurate impressions
• Always read the information on labels of OTC medicines
• Relieving the symptoms of an illness is not the same as
curing the illness
• Some OTC drugs (stimulants, nasal sprays, sedatives, eye
drops, cough syrups, and laxatives) can result in dependency