hart13 ppt ch12

© 2011 McGraw-Hill Higher Education. All rights reserved.

Chapter 12Chapter 12

Dietary Supplements and Over-the-Counter

Drugs


Dietary Supplements vs. Dietary Supplements vs. DrugsDrugs

Drugs and food share certain characteristics They contain chemicals that interact

with the body’s physiology

Drugs and food are not regulated in the same ways

Supplements may be thought of as drugs by consumers but are legally classified as food products


Dietary Supplements vs. Dietary Supplements vs. DrugsDrugs

Pills, capsules, liquids, and powders classified as dietary supplements may be thought of as drugs by consumers BUT They are legally classified as food products They are treated very differently by the Food and

Drug Administration (FDA)

Example of Saint John’s wort Many people take it for its suggested ability to

improve mood, reduce anxiety, and induce sleep Classified as a dietary supplement, it is regulated

more like a food than a drug


Food, Drug, and Cosmetic ActFood, Drug, and Cosmetic Act

A drug is a product intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease

Before marketing, drugs must be shown to be Safe when used as directed Effective for their intended use

Food products and ingredients must be Safe Pure (unadulterated) They are not required to show that they are

effective or provide any benefit


Dietary Supplements: Dietary Supplements: RegulationRegulation

Dietary Supplement Health and Education Act (DSHEA) of 1994 Passed in part due to pressure on

Congress from the supplement industry in response to indications that the FDA was planning to expand regulation of dietary supplements

Defined supplements and set regulations for safety and labeling


DSHEA: Supplement LabelingDSHEA: Supplement Labeling

Same label format as those for packaged foods Not as accurate or precise as drug labels

Testing has found that potency varies from bottle to bottle and even capsule to capsule Amounts listed on label are for a plant substance and not

the presumed active ingredient

Ingredients listed on the label may not be the actual active ingredients in a plant or herb

Dosage guidelines are not well-established for many supplements

There is no requirement for proof of effectiveness


DSHEA: Defining Dietary DSHEA: Defining Dietary SupplementsSupplements

DSHEA expanded the definition of supplements to include a variety of substances: Vitamins and minerals Herbs and concentrates and extracts of herbs Amino acids

Many forms: Tablets Capsules Liquids Powders


DSHEA: Defining Supplement DSHEA: Defining Supplement SafetySafety

FDA can declare a product to be adulterated (unsafe) only if it presents a significant or unreasonable risk of illness or injury

Ingredients already on the market at the time of the Act: Considered safe enough to be sold unless the FDA

can demonstrate a risk

New ingredients: Need some evidence that they would not present a

significant or unreasonable risk BUT much less evidence is required than for drugs


Supplement Labeling: Supplement Labeling: Health ClaimsHealth Claims

FDA authorizes a small number of health claims that food and supplement manufacturers can use if their products meet certain requirements Based on available scientific research Examples:

Adequate calcium intake and reduced risk of osteoporosis

Soluble fiber intake and reduced risk of heart disease


Supplement Labeling: Supplement Labeling: Structure/Function ClaimsStructure/Function Claims

Unapproved health claims are not allowed, BUT

Supplement labels can make so-called structure/function claims Relate to the structure or functioning of the

body or to overall well-being Examples:

Maintains cell integritySupports the immune system


Supplement Labeling: Supplement Labeling: Structure/Function ClaimsStructure/Function Claims

Not a claim to prevent or treat a disease Not reviewed by the FDA Must carry a disclaimer:

This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

Supplement LabelingSupplement Labeling



Pros and Cons of Current Pros and Cons of Current Supplement RegulationsSupplement Regulations

Pro: Many more supplements on the market Consumers have more options

Con: Much less research available about safety and effectiveness of supplements

Con: Supplements remain on the market unless or until the FDA presents clear evidence of risk Example: Ephedra, a stimulant taken by people

wanting to lose weight First evidence of safety concerns published by the FDA in

1994 With the burden of proof now with the FDA, it took 10

additional years for the FDA to compile evidence to get ephedra off the market


Supplements to AvoidSupplements to Avoid

Definitely hazardous Aristolochic acid

Very likely hazardous Comfrey Androstenedione Chaparral Germander Kava Cesium Colloidial Siver Graviola

Likely hazardous Bitter orange Organ/glandular extracts Lobelia Pennyroyal oil Scullcap Yohimbe


Dietary Supplement ActDietary Supplement Act

Introduced by Senator John McCain in February 2010.

Would have required all manufacturers to register with the FDA and provide a complete list of ingredients.

The FDA could also recall any ingredient they found to be unsafe.

The dietary supplement industry mounted a campaign against the regulation and McCain withdrew the bill


Examples of Psychoactive Examples of Psychoactive Dietary SupplementsDietary Supplements

Saint John’s wort (Hypericum perforatum) Was originally thought to prevent possession by

demons Currently used as a potential treatment for both

anxiety and depression

Research results have been mixed, but there is some evidence supporting its use for depression

It may interact with prescription drugs, so users should notify their physicians



S-adenosyl-L-methionine (SAMe) A naturally occurring substance, the active

form of amino acid methionine Researched as a possible antidepressant Not yet any solid evidence it is more

effective than placebo



Ginkgo biloba Long history of medical use in China Active ingredients and mechanisms of action

haven’t yet been identified Reduces blood clotting; thins blood to improve

circulation Potentially risky if used with aspirin or other drugs

that reduce clotting

Research suggests a slight ability to improve memory


Dietary Supplements vs. Dietary Supplements vs. Drugs: ReviewDrugs: Review

Supplements: no requirement for proof of effectiveness

Disclaimer for any structure/function claim: “This statement has not been evaluated by

the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”


Over-the-Counter (OTC) Over-the-Counter (OTC) DrugsDrugs

A drug is a product intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease

Usage by Americans Americans self-treat four

times as many health problems as doctors treat, often with OTC drugs

Americans spend over$18 billion per yearon OTC drugs


OTC RegulationOTC Regulation

1962 Kefauver-Harris amendment required that all drugs be evaluated for safety and efficacy

Active ingredients reviewed individually; three standards considered:

1. GRAS (generally recognized as safe) means that, given currently available information, the ingredient is considered safe Nothing is entirely safe Safe = a “low incidence of adverse reactions or significant

side effects under adequate directions for use and warnings against unsafe use as well as low potential for harm which may result from abuse”


OTC RegulationOTC Regulation

2. GRAE (generally recognized as effective) = a reasonable expectation that the pharmacological effect of the drug will provide clinically significant relief of the type claimed in a significant proportion of the target population


OTC LabelingOTC Labeling

3. GRAHL (generally recognized as honestly labeled) More than 300,000 OTC products on the

market contain fewer than 1,000 total active ingredients now reviewed in over 80 therapeutic classes. Those that the FDA has classified as safe and

effective



Layout, headings, and topics are consistent, and language has been made clearer and more concise, with less medical terminology

Consistent labels make it easier for consumers to compare products

Uniform labeling standards were adopted in 1997 to reduce consumer confusion


OTC vs. Prescription DrugsOTC vs. Prescription Drugs

1938 Food, Drug, and Cosmetic Act established a classification of drugs that can be sold only by prescription

Possible differences between OTC and prescription drugs Dosage: An OTC version of a drug may come in

smaller doses Chemicals: A prescription drug may contain a

chemical not allowed for OTC sale due to potential toxicity


OTC vs. Prescription DrugsOTC vs. Prescription Drugs

FDA panels review products and may switch drugs to OTC status Examples of drugs switched to OTC status

include ibuprofen (analgesic), orlistat (weight-loss), and cetirizine (antihistamine)

Should there be a class of drugs between OTC and prescription? Pharmacist recommended?


Examples of Psychoactive Examples of Psychoactive OTC DrugsOTC Drugs

Stimulants FDA allows stimulants to be sold to “help

restore mental alertness or wakefulness when experiencing fatigue or drowsiness”

Only ingredient allowed by FDA in OTC stimulants is caffeine

Combinations of caffeine and other stimulants (e.g., ephedrine) are not allowed



Weight-control products Phenylpropanolamine (PPA) was sold over

the counter by the late 1970s Combinations of PPA and caffeine sold for

a brief period before being banned in 1983 Concerns over effectiveness of PPA and

the safety of recommended dosage due to its effects on blood pressure

2000: FDA requested all companies to stop marketing products containing PPA



Weight-control products Additional products banned due to lack of

safety or effectivenessEphedrineBenzocaine-containing candies and gumsStarch blockersCholecystokinin (CCK)

Currently, one FDA-approved weight-control OTC drug: Orlistat (alli)



Sedatives and sleep aids Early OTC sedatives and sleep aids

acetylcholine receptor blocker scopolamine + antihistamine methapyrilene

FDA review panel eventually rejected scopolamine but accepted methapyrilene

Later methapyrilene was found to cause cancer in rats, so it was no longer classified as GRAS

Different antihistamines were then marketed, and brands changed active ingredients frequently

Currently, there are no approved OTC sedatives; OTC sleep aids contain antihistamines


OTC Analgesics: Pain and OTC Analgesics: Pain and PeoplePeople

Anesthetics (“without sensibility”) reduce all types of sensation or block consciousness completely

Analgesics (“without pain”) reduce pain selectively without causing a loss of other sensations

Types of pain, based on place of origin Visceral pain from nonskeletal portions of the body

Relieved by opioids Somatic pain from muscle or bone

Relieved by aspirin and related products

About 35 percent of patients obtain pain relief from a placebo


OTC Analgesics: OTC Analgesics: Acetylsalicylic Acid (Aspirin)Acetylsalicylic Acid (Aspirin)

Development Long historical use of teas and extracts of willow

and poplar bark for pain relief Active ingredient—salicylic acid—was identified,

synthesized, and mass-produced in the nineteenth century

Related compound—acetylsalicylic acid—was synthesized in 1898 by a Bayer Laboratories’ chemist; had fewer side effects 1899: Patented and released for prescription sale in the

form of a white powder 1915: Sold over the counter in tablet form



Therapeutic use1. Analgesic—effectively blocks mild-to-moderate

somatic pain Maximum pain relief occurs in about one hour; effect

lasts for up to four hours Especially effective for headache and musculoskeletal

pain

2. Antipyretic—reduces fever Does not lower body temperature in someone with

normal body temperature Causes vasodilation of peripheral blood vessels and

increased perspiration



Therapeutic use3. Anti-inflammatory—reduces swelling,

inflammation and soreness

Relatively low toxicity Absorbed from the stomach and intestines



Effects/Risks Increases bleeding time by inhibiting blood platelet

aggregation Can cause bleeding problems for surgical patients May prevent heart attacks and strokes by preventing clots in

high-risk patients Induces gastrointestinal bleeding Reye’s syndrome—rare but serious disease

Effects can include disorientation, personality changes, lethargy, coma, and death

CDC recommends that aspirin should not be given to anyone under age 20 who has a suspected viral illness such as cold, influenza, or chicken pox

Accidental poisonings and suicide attempts



Mechanism of action Prostaglandins are local-acting hormones

Released when cell membranes are injuredMediate pain in injured areas by sensitizing

neurons to stimulation

Aspirin inhibits two forms of the cyclooxygenase (COX) enzymeBlocks the synthesis of pain-causing

prostaglandins

Aspirin also acts on prostaglandins involved in heat regulation


OTC Analgesics: OTC Analgesics: AcetaminophenAcetaminophen

Acetaminophen is closely related to phenacetin, a now banned pain reliever

Compared to aspirin: As effective in analgesic and antipyretic effects Less useful as an anti-inflammatory drug Causes less gastric bleeding

Overuse of acetaminophen can cause serious liver disorders Not safer than aspirin if recommended dose is

exceeded As of 2009, the FDA limited the maximum single

adult dose to 650 mg for OTC products


OTC Analgesics: Ibuprofen OTC Analgesics: Ibuprofen and Other NSAIDsand Other NSAIDs

Ibuprofen is an aspirin-like analgesic and anti-inflammatory; it also inhibits COX enzymes

Potential side effects Nausea and stomach pain Liver damage (if taken in large amounts)

Class of drugs is known as nonsteroidal anti-inflammatory drugs (NSAIDs)

Originally available by prescription, but now also available over the counter


OTC Cold and Allergy OTC Cold and Allergy RemediesRemedies

All-too-common cold Colds are viral infections, caused by

viruses in the rhinovirus or coronavirus families

Viruses damage or kill the cells they attack In the case of colds, the affected cells are

on the upper respiratory tract Symptoms include coughing, sneezing,

and production of fluid by the mucous membranes



All-too-common cold Most cold viruses enter the body through

the nose or eyes; they are usually transmitted via an infected person’s hands

Frequent handwashing is a good strategy to reduce the risk of contracting a cold



Treatment of cold symptoms—no cure Modern cold remedies contain three

common types of ingredientsAntihistamines for temporary relief of runny

nose and sneezing– Of questionable benefit for cold symptoms

Nasal decongestants for temporary relief of swollen nasal membranes

Analgesic-antipyretics for temporary relief of aches and pains and fever reduction



Allergy and sinus medications Rely mainly on antihistamines May also include an analgesic


Choosing an OTC ProductChoosing an OTC Product

Most products contain one or more of only a small number of ingredients, in different combinations An informed consumer can understand a large

proportion of these products by being familiar with only a few drugs

Single ingredient medications may be preferable to combination products Avoid medication interactions and side effects of drugs

that are designed to treat symptoms you may not have


Chapter 12Chapter 12

Dietary Supplements and Over-the-Counter

Drugs

hart13 ppt ch12

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