Albia Dugger • Miami Dade College

Chapter 14 Over-the-Counter

Drugs

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

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

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

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

Children at risk for adverse reactions to OTC drugs

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

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

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

Commonly Used Herbal Supplements

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

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

Aspirin and Children

• Children with chicken pox or flu-like symptoms should not be given aspirin

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

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

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

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

The best way to prevent colds

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

Side Effects of Antihistamines

• Dizziness• Weakness• Nervousness• Poor concentration• Headache• Drowsiness

• Blurred vision• Difficulty urinating• Constipation• Hives• Dry mouth, nose, and

throat

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

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

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

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

Drawbacks of Antacids

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

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

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

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

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