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PS268 - MIDTERM1.docx

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Bruce Mc Kay

Drugs and Behaviour Review Chapter12 – Natural Health Products (NHP) and Over the Counter Drugs (OTC) -Food and Drug Act (FDA) -1990s concern over NHP NHP include vitamins, mineral supplements, herbal remedies, homeopathic medicines, traditional medicines, traditional Chinese and Ayuvedic medicines, probiotics, amino acids and essential fatty acids Growth in the public awareness and demand fueled by: [1] an increase in interest in foods the can be used in prevention and as a treatment of illness [2] growing belief that NHPs are better than conventional (chemical) drugs [3] emergence of aggressive multilevel marketing organizations that have become distributors of purported natural cures and preventions -NHPs were promoted as foods -Drug manufacturers have to demonstrate safety and effectiveness -However, foods have to ensure safety and purity, not their efficacy -NHP manufacturers were exempt from providing information on potential contraindications, side effects or toxicities associated with the use of their products -Natural Health Products Directorate (NHPD) NHP as products manufactured, sold, or represented for use in (1) diagnosing, treating, mitigating, or preventing a disease, a disorder, or an abnormal physical state or its symptoms in humans (2) Restoring or correcting organic function in humans (3) modifying organic function in humans, such as modifying functions in a manner that maintains or promotes health. Through these regulations, NHPS, must be safe to use as OTC products and do not need a prescription to be sold *NHP must be supported by evidence -to constitute traditional use, a NHP must have a history of at least 50 consecutive years of use as a medicinal ingredient within a cultural belief system or healing paradigm (traditional Chinese medicine) span chosen because it represents two generations, thereby allowing possible reproductive side effects to be identified -applicant must include references that support the recommended condition of use and that describe dose information and the method of preparation -Eight digit product license number preceded by the letters NPN (Natural Product Number) or in the case of a homeopathic medicine, by the letter DIN-HM. -71% of Canadians regularly use NHPs, 38% on a daily basis -most common vitamins (57%), Echinacea (15%), herbal remedies (11%), glucosamine (8%), and homeopathic medicine (5%). COMMON NHPs St. John’s Wort – Hypericum perforatum -devil’s scourge -treatment of depression and anxiety “to relieve restlessness or nervousness and to help treat symptoms of sleep disorders” -limited evidence on the effectiveness of treating anxiety, but several studies have found it’s usefulness in treating depression Hypericum extracts are [1] superior to placebo in patients with major depression [2] similarly effective as standard standard antidepressants [3] have fewer side effects than standard antidepressants -interacts with various prescription drugs (antiretroviral agents, oral contraceptives, digoxin, cyclosporine, warfarin, theophylline, and anti epilepsy drugs) SAMe – S-adenosyl-L-methionine -naturally occurring substance found in the body 0active form of the amino acid methionine, acts as a ‘methyl donor’ in a variety of biochemical pathways -1970s, SAMe was tested in Italy for its effectiveness as an antidepressant -more effective than placebo and apparently no less effective than tricyclic antidepressants “to help support a healthy mood and balance” Natural Male Enhancements -products as dietary supplements and not as NHPs -Enzyte Tribulus terrestris – clinical studies have not been done Panoax ginseng – might be helpful in treating erectile dysfunction, not clear Ginkgo boloba – mixed but likely no effect Avena Sativa – oat plant, oatmeal. Aphrodisiac Epimedium sagittatum – horny goat weed Traditional Chinese Herbal Medicine Dilate blood vessels, possibly lowering blood pressure No solid science backs up the effectiveness of this ingredient Tablets and capsules are treated as foods, not drugs in the States, and as such there is no requirement that the manufacturer demonstrate the effectiveness of the products Ginkgo Biloba “to improve memory and cognitive function” -reduce blood clotting, blood thinner, improves circulation -dangerous to combine with Aspirin -Appears safe for the use as a stand alone drug -unreliable- dementia or cognitive -interesting to note that studies using animal and cell culture models of stroke have recently demonstrated the ability of ginkgo extracts to protect neurons against oxidative stress Caffeine “temporarily restore mental alertness or wakefulness when experiencing fatigue or drowsiness” -2004, caffeine based cerebral stimulants were trasitioned from OTC to NHP …Wake ups, Full Throtle, Peptime energy extreme between 100-200mg of caffeine medium coffee contain 80mg OTC – Tylenol Untral relief contains 65mg of caffeine Difference is that these products are not intended to be used as stimulants. Caffeine is there as an adjunct, enhancing the response to the active ingredient acetaminophen -to use Tylenol to temporarily restore wakefulness or mental alertness is inappropriate as it require the unnecessary co-consumption of acetaminophen, which has been linked to live disease Weight-Control Products -before 2001 products containing phenylpropanolamine (PPA), a psychoactive drug of the amphetamine chemical class, were available and considered safe and effective anorexic agents AYDS – 1970s&1980s sold in candy form, contained PPA -1980s – recommended dose of 75mg, PPA has been shown to increase blood pressure -increased risk of hemorrhagic stroke (bleeding in brain) -2001/2002 no products contained PPA Ephedra (Ma Huang) – ephedra and caffeine combination to loose weight 4Ever Fit, sold ephedra and caffeine pills packaged in sepearate bottles but sold together in aconvenience pack -the active ingredients of ephedra are the alkaloids ephedrine and pseudo
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