Regulations Affecting Medications

•1906 Pure Food & Drug Act (drug must be pure & accurately labeled)

•1937 Federal Food, Drug & Cosmetic Act (drug must be demonstrated to be safe when used as directed)

•1962 Kefauver-Harris Amendment (drug must be demonstrated to be effective before it can be marketed for that use)

•Evaluation of whether drugs meet these requirements continues today (recall the testing required for FDA approval)

•Then came the 1994 Dietary Supplement Health Education Act allowing products labeled as such to be essentially free from FDA regulation

Herbal or Natural Remedies and Dietary Supplements

Are “natural” remedies better?

Are “natural” remedies safe?

Are “natural” remedies worth the money?

Should “natural” remedies be subject to the same regulations as “drugs”?

• “Natural” plant products are not necessarily distinctly different from “drugs”. The majority of drugs are derived from or based on plants.

• “Natural” does not mean “meant for the human body”. Nature is full of poisons!

• Use of natural remedies still relies on knowledge and careful use.

Herbal/Natural Remedies: Buyer Beware

• Purity, safety, effectiveness or batch-to-batch quality control of herbals are NOT regulated by FDA (see Nov, 1995 Consumer Reports)

• No FDA regulation of claims made on packages except that they cannot say that they treat a specific illness; no research required.

• Huge herbal/supplement lobby has successfully campaigned against regulation.

• Don’t assume they are safe - read about them in reputable source (Herbs of Choice, Honest Herbal). (RM333, Reference shelves)

Example: Ginseng (used to improve health and energy)

• Rite Aid Imperial ~.001% ginsenosides

• Naturally Korean ~.003%

• Solger Korean, Nature’s Resource, KRG Korean Red ~.025%

• Ginsana ~.030%

• American Ginseng ~.050%

• Herbal Choice .065%

• Walgreen’s Gin-Zing .076%

Herbal/Natural Remedies: Buyer Beware

• Brands may vary 80 fold in concentration of active ingredient – some may be inactive! (see 19)

• Select standardized brands with concentration and dose information. (Nature’s Way, Quanterra, Lichtwer, Bayer)

• Tell your doctor what you are taking – herbs can produce drug interactions and side effects; avoid herb mixtures

• Even beneficial herbs, like beneficial drugs, may not be for every person.

Examples

• Chamomile –used as a digestive and anti-inflammatory, but may irritate those with ragweed/flower allergies

• Echinacea – may boost immunity but shouldn’t be used in pregnancy or autoimmune disorders

Ma Huang, Ephedra, and Ephedrine Containing Products

• Wide range of “herbals” and “supplements” and some OTCs contain these stimulants

• amphetamine-like but not quite as potent or psychoactive, but does stimulate body

• properly used (low doses, occasional) these have been safe and beneficial (e.g. Anti-asthma)

• higher doses or unknown doses much riskier even in young people (stroke, heart attack)

• as with other diet drugs, weight loss tends to be temporary

Ephedra

St. Johns-Wort (Hypericum perforatum)

• ~300 mg of .3% extract is effective in treating mild /moderate depression (not serious cases)

• takes 2-4 weeks for hypericin to work (like drugs)

• Blocks reuptake of 5HT, NE and DA

• side effects: restlessness, stomach upset, dry mouth, dizziness, photosensitivity

• don’t use WITH other antidepressants; don’t use in pregnancy

• Interferes with a CYP enzyme changing sensitivity to drugs such as codeine, caffeine & psychotherapeutic drugs

Other Herbals of Interest

• Ginkgo- may improve blood flow to brain, sold for “mental sharpness” (but increases your tendency to bleed)

Kava

• South Pacific sedative/intoxicant

• antianxiety, sleep-promoting depressant-like action (interacts with other depressants)

Valerian

• also produces mild depressant action

• Kava and Valerian seem to act on GABA receptors like depressant drugs

Sample Drug Interactions

• Gingko & blood thinners

• St. John’s Wort & antidepressants

• Ephedra & caffeine, decongestants, stimulants

• Ginseng and warfarin (Coumadin)

• Kava & sedatives, alcohol, sleeping aids, antipsychotics

• So it is even more important to be a cautious informed consumer of natural/herbal remedies and supplements since regulatory agencies, in this case, cannot protect you.

Toxic Herbs Still Sold

• Chapparal & Comfrey – causes liver damage

• Ephedra (Ma huang) – hi BP and HR, increased risk of stroke, heart attack

• Lobelia – vomiting, seizures, coma

• Yohimbe – GI problems, psychosis, paralysis

Examples of herbal side effects

• Ginkgo – bleeding

• St. John’s Wort – GI upset, fatigue, dizziness, confusion, dry mouth, allergic reactions

• Ephedra – hi BP, arrhythmias, anxiety, insomnia, tremors, kidney stones

• Kava – sedation, slurring, ocular & neck spasms, rash, PD-like symptoms