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PSY 320 Chapter 12 - Dietary Supplements & OTC

by: Elliana

PSY 320 Chapter 12 - Dietary Supplements & OTC PSY 320

Marketplace > University of Miami > Psychlogy > PSY 320 > PSY 320 Chapter 12 Dietary Supplements OTC
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Combined textbook & lecture notes
Drugs & Behavior
Dr. Marc Gellman
Class Notes
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This 6 page Class Notes was uploaded by Elliana on Sunday February 14, 2016. The Class Notes belongs to PSY 320 at University of Miami taught by Dr. Marc Gellman in Spring 2015. Since its upload, it has received 57 views. For similar materials see Drugs & Behavior in Psychlogy at University of Miami.

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Date Created: 02/14/16
PSY 320 Drugs & Behavior Chapter 12 Dietary Supplements & Over-the-Counter Drugs Dietary Supplements: Food or Drug? • Legally classified as a food product • Drugs & food are similar in some respects • Both contain chemicals that interact w. the body's physiology • Drugs are defined as: ◦ A product intended for use in diagnosis, cure, mi▯ga▯on, treatment, or preven▯on of a disease • Drugs must be shown to be: ◦ Safe when used as directed esu dedne t n i ro f ev▯ce ◦ff E • These requirements do not apply to supplements! Over-the-Counter (OTC) Drugs • Self-prescribed for treatment of self-diagnosed illnesses • Americans self-treat 4x as many health problems as doctors treat s gurd CTO .w n◦ e▯ O OTC vs. Prescrip▯on Drug s • 1938 Food, Drug, & Cosme▯c Act ◦ Established a classifica▯on of drugs that can be sold only by prescrip▯on • Possible differences btwn OTC & prescrip▯on drugs: ◦ Dosage: • OTC version of a drug may come in smaller doses ◦ Chemicals: • A prescrip▯on drug may contain a chemical not allowed for OTC sale due to poten▯al toxicity History • 1994 Dietary Supplement Health & Educa▯on Act (DSHEA) ◦ Passed in part due to pressure on congress from supplement industry ◦ Industry wanted to limit FDA regula▯on ◦ Redefined which substances could be "dietary supplements" ◦ Redefini▯on of presumed safety ◦ Vague health claims w.o proof were allowed • Sellers do not have to prove claims • Only have to provide evidence that claims are not false or misleading • Essen▯ally: DSHEA expanded the defini▯on of supplements to include a variety of substances ◦ Vitamins & minerals ◦ Herbs (whole, concentrates, extracts) ◦ Amino acids • Congress's priority in payments from the industry over safety/health of consumers • Ingredients already on the market at the ▯me of the Act: ◦ Considered safe enough to be sold unless the FDA can demonstrate a risk 1 PSY 320 Drugs & Behavior • FDA can declare a dietary supplement to be unsafe or unadulterated ◦ Only if it presents a significant or unreasonable risk of illness/injury • Recent rules emphasizing safety: ◦ Good manufacturing prac▯ces rules ◦ Adverse Events Repor▯ng process ◦ But rules much more lenient than for drugs • *Dietary supplements cannot claim to be a treatment for a disorder ◦ Labels must carry a disclaimer: "This statement has not been evaluated by the Food & Drug Administra▯on. This product is not intended to diagnose, treat, cure, or prevent any disease." • DSEA: Boon or Threat to consumers? : no◦ B • Many more supplements on the market • Consumers have more op▯ons : sn ◦ C • Much less research available on safety & effec▯veness • Supplements remain on the market un▯l the FDA presents clear evidence of risk ▪ Basically someone has to die to raise concerns • Case Study: Ephedra ◦ S▯mulant for weight loss ◦ 1994: First evidence of safety concerns published by FDA • Took more than 10 yrs for FDA to compile evidence (cases of death) to get ephedra off the market • Consumers complained there were not enough regula▯ons protec▯ng them • 2010 Dietary Supplement Act ◦ Senator John McCain introduced bill • All manufacturers would have to register with FDA • Manufacturers would have to provide a complete list of ingredients • FDA could recall any ingredient they found to be unsafe : emoc t ◦ O • Dietary supplement industry mounted campaign against regula▯on • McCain withdrew bill FDA Regula▯on of OTC Products • 1962 Kefauver-Harris amendment ◦ Required that all drugs be evaluated for safety & efficacy ◦ FDA charged w. reviewing all OTC drugs currently on the market • Approximately 300,000 products • Impossible task? : no▯u l◦o S • Only ac▯ve ingredients reviewed • 300,000 individual products contain fewer than 1,000 total ac▯ve ingredients • OTC Regula▯on: 3 Standards ◦ GRAS • Generally Recognized as Safe ▪ Given currently available info, the ingredient is considered safe ▪ Safe = "low incidence of adverse reac▯ons" ▪ Note that no drug is en▯rely sage 2 PSY 320 Drugs & Behavior ◦ GRAE • Generally Recognized as Effec▯ve ▪ Reasonable expecta▯on that the pharmacological effect of the drug will provide clinically significant relief ◦ GRAHL • Generally Recognized as Honestly Labeled • OTC drug labeling: ◦ Uniform labeling standards adopted in 1997 • To avoid confusion • Layout, headings, topics consistent • Language made clear & concise • Less medical terminology ◦ Consistent labels make it easier for consumer to compare products • OTC drug review process: ◦ FDA reviews products & may switch drugs to OTC status : CTO o t dehc t i ws s gu ◦r D • Ibuprofen (Advil: analgesic) • Iansoprazole (Prevacid: heartburn) • Fexofenadine (Allegra: an▯histamine) Plant/Supplements • Saint John's Wort ◦ Hypericum Perforatum ◦ Used for centuries • Once thought to prevent possession by demons ◦ Currently used as poten▯al treatment for anxiety/depression ◦ May interact w. prescrip▯on drugs • SAMe ◦ S-adenosyl-L-methionine ◦ Naturally occurring substance found in the body • Ac▯ve form of amino acid methionine ◦ Possible an▯depressant • Gingko Biloba ◦ Long history of medical use in China ◦ Ac▯ve ingredients unclear ◦ Reduces blood clo▯ng • May improve circula▯on ◦ Poten▯ally risky if used w. aspirin or other clot-reducing drugs ◦ Research suggests slight* improvements in memory in some people • Really only for ppl declining w. old age (not Alzheimer's) • Doesn't work for college students w.o memory issues • Weight Control Products ◦ Biggest dietary supplement market de r i uqe r s senev▯ceffe f o ecn ed i ve ◦o N ◦ I.E. Herbalife • Many original products contained ephedra before FDA ban • Now many products contain large doses of caffeine 3 PSY 320 Drugs & Behavior Psychoac▯ve OTC Drugs • S▯mulants ◦ FDA allows s▯mulants to be sold to "help restore mental alertness/wakefulness when experiencing fa▯gue or drowsiness) • Only legal OTC ingredient is caffeine • I.E. Vivarin • Combina▯ons of caffeine & other ingredients (ephedrine) not allowed • Seda▯ves & Sleep Aids ◦ Early OTC seda▯ves & sleep aids • Combina▯on of scopolamine (acetylcholine receptor blocker) & methapyrilene (an▯histamine) • Found to be unsafe ◦ Brands changed ac▯ve ingredients frequently • Currently diphenhydramine is the only an▯histamine legally sold as a sleep aid • Weight-Control Products ◦ 1970s phenylpropanolamine (PPA) legal in OTC ◦ 2000 FDA requested all companies to seek marke▯ng PPA products • Concerns over safety & effec▯veness ◦ Currently, 1 FDA approved weight-control OTC drug: • Orlistat (Alli) ◦ Weight-control market shi▯ed largely from OTC drugs to less well regulated dietary supplements • Analgesics: Pain-killers ◦ Anesthe▯cs reduce all types of sensa▯on or block consciousness completely • General: blocks consciousness completely • Local: injected at site of injury to numb area ◦ Analgesics reduce pain selec▯vely w.o causing loss of other sensa▯ons ◦ Types of pain based on place of origin: • Visceral pain from non-skeletal por▯ons of body s d i o i po yb deve i l▪ e R • Soma▯c pain from muscle or bone ▪ Relieved by OTC analgesics • Aspirin • Acetaminophen • Ibuprofen ◦ About 35% of pa▯ents obtain pain relief from placebo OTC Analgesics: Aspirin • Long historical use of teas & extracts of willow & poplar bark for pain relief ◦ Used for pain-relief of arthri▯s in inhabitants of damp climates • 19th century: ac▯ve ingredient salicylic acid iden▯fied, synthesized, & mass-produced • 1989: Acetylsalicylic acid (less acidic product) synthesized by Bayer Labs chemist - had fewer side effects • 1899: Patented & released ini▯ally from prescrip▯on sale as white powder ◦ Consumed as powder mixed in water • 1915: Aspirin sold OTC in tablet form • Aspirin: Therapeu▯c Use 4 PSY 320 Drugs & Behavior ◦ Analgesic • Effec▯vely blocks mild-to-moderate soma▯c pain • Especially effec▯ve for headache & musculoskeletal pain c▯e r yp▯ ◦n A • Reduces fever • Causes vasodila▯on of peripheral blood vessels & increases swea▯ng ◦ An▯-Inflammatory • Reduces swelling, inflamma▯on, & soreness • Used extensively for arthri▯s treatment • Mechanism of Ac▯on ◦ Prostaglandins - local hormones manufactured & released when cell membranes are distorted or damaged (injured) ◦ Aspirin blocks synthesis of prostaglandins by inhibi▯ng enzymes COX-1 & COX-2 ◦ Blocks synthesis in the anterior hypothalamus • Effects & Risks ◦ Inhibits blood platelet aggrega▯on (clo▯ng) • Can cause bleeding problems for surgical pa▯ents • May prevent heart a▯acks & strokes by preven▯ng clots in high-risk pa▯ents ◦ Induces gastrointes▯nal bleeding emo rdny S s ' ey◦e R • Rare but serious disease • Symptoms include: disorienta▯on, personality changes, lethargy, coma, death • Almost all cases occurred in ppl under 20 y.o who have had a viral illness such as influenza or chicken pox • Prostaglandins ◦ Local-ac▯ng, pain-causing hormones • Released when cell membranes are injured • Mediate pain in injured areas by sensi▯zing neurons to s▯mula▯on ◦ Analgesic ac▯on: • Aspirin inhibits synthesis of prostaglandins by effec▯ng 2 forms of cyclooxygenase (COX) enzyme • Thereby blocking synthesis of pain-causing prostaglandins ◦ An▯pyre▯c ac▯on: • Aspirin acts on prostaglandins involved in heat regula▯on • Reduces heat OTC Analgesics: Acetaminophen (Tylenol) • Compared to Aspirin: ◦ As effec▯ve in analgesic & an▯pyre▯c effects ◦ Less useful as an▯-inflammatory drug • Risks: ◦ Overuse can cause serious liver disorders ◦ DAWN data: Acetaminophens far surpassed Aspirin for ER visits & deaths ◦ FDA has limited maximum single capsule amount to 650 mg for OTC products OTC Analgesics: Ibuprofen & other NSAIDS • Class of drugs known as Nonsteroidal An▯-Inflammatory Drugs (NSAIDs) ◦ Originally available by prescrip▯on, now also available OTC • Ibuprofen is an NSAID 5 PSY 320 Drugs & Behavior ◦ Effec▯ve as an analgesic & an▯-inflammatory ◦ Like aspirin, inhibits COX enzymes • Poten▯al side effects: ◦ Nausea & stomach pain ◦ Liver damage (if consumed in large amounts) OTC Cold & Allergy Products • Cold symptoms can be treated, not cured • Modern cold remedies contain 3 common types of ingredients: ◦ An▯histamines: for temporary relief of runny nose & sneezing • Also for relief of allergy symptoms ◦ Nasal decongestants: for temporary relief of swollen nasal membranes ◦ Analgesic-an▯pyre▯cs: for temporary relief of aches & pains & fever reduc▯on 6


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