Dietary Supplements Flashcards
What is complementary medicine?
Complementary medicine refers to health practices that are used with conventional medicine. The term alternative medicine is used when conventional medicine is not used
What is natural medicine?
Natural medicine is a general umbrella term that includes herbals (plant products), vitamins, minerals and many substances that are not plant-derived but exist in nature, such as glucosamine from shellfish
What are dietary supplements regulated by?
Dietary supplements are regulated by the Dietary Supplement Health and Education Act (DSHEA) of 1994
What does that DSHEA require?
DSHEA requires the manufacturer to ensure that their products are safe before they are marketed. Once the supplement is marketed, the FDA must show it is “unsafe” before it can restrict use or remove it from the marketplace. The company selling or distributing the supplement must forward adverse event reports to the FDA
Where can adverse events from supplements be reported?
FDA’s Safety Reporting Portal, which sorts safety issues to the correct FDA site
What is FDAble?
FDAble is a searchable database of adverse events caused by dietary supplements, medications, devices and tobacco products
Where can information of natural medicines be found?
Information on natural medicines can be found in general drug references and the Natural Medicines Database
What are some differences between dietary supplements and drugs?
- Supplement safety is the manufacturer’s responsibility, which should be proven prior to release. After release, the FDA can remove a supplement if it is found to be unsafe. In contrast, drugs must be proven safe and effective to the FDA prior to release
- Supplements cannot claim to treat, cure or mitigate (lessen) a condition. In contrast, drug claims are baed on FDA approval
What is on a supplements facts label?
The Supplement Facts label is similar to the label required on food products. It includes the ingredients, quantities, serving size, servings/container, calories, calories from fat, total fat and saturated fat, cholesterol, sodium, carbohydrate, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium and iron, when present in measurable amounts
What is on an OTC Drug Facts label?
The OTC Drug Facts label includes ingredients, purpose, uses, warning, instructions, excipients and how to avoid an allergic reactions. OTC drugs can include a package insert similar to prescription drugs; this depends on the product’s approval process
What kinds of claims can manufacturers not make with dietary supplements?
Manufacturers cannot make claims that the product treats or cures a condition. Health claims are limited to the nutrient content, the relationship to health and the impact on normal body structure or function. Products that make claims on the structure or function of the body must state in a “disclaimer” that the FDA has not evaluated the claim
What organizations establishes standards for dietary supplements?
United States Pharmacopeia (USP)
What are four areas of particular concern for supplements?
Four areas of particular concern are supplements that interact with prescription drugs, increase bleeding risk or cause hepatotoxicity or cardiotoxicity
What do dietary supplements facts label include?
The Supplement Facts label includes the recommended daily intake (RDI) and the amount of each ingredient in the product
What is a label update associated with folic acid?
It will have units listed on labels in DFE instead of in micrograms. Folic acid 600 mcg DFE = 360 mcg of folic acid daily, the RDA for women in child-bearing years
What are some significant drug interactions of St. John’s Wort?
- SJW induces CYP450 3A4, 2C19, 2C9, 1A2 enzymes and p-glycoprotein (P-gp), which lowers levels of other drugs
- SJW is serotonergic and is often implicated in serotonin syndrome
- SJW causes photosensitivity and requires counseling on sun protection and avoidance
- SJW may lower the seizure threshold
What are some supplements that may increase bleeding risk?
- The “5 G’s”: garic, ginger, ginkgo, ginseng and glucosamine
- Fish oils (at higher doses)
- Vitamin E
- Dong quai
- Willow bark
What are some examples of supplements with risk of liver toxicity?
Black cohosh, kava, chaparral, comfrey, green tea “extracts”
What are some supplements with risk of cardiac toxicity?
- Ephedra was removed from the market due to reports of cardiac toxicity
- DMAA (dimethylamylamine) is an amphetamine derivative used in body-building or performance-enhancement (increases blood pressure and heart rate)
- Licorice contains glycyrrhizin (Glycyrrhizin, taken in excess, can lower potassium and increase blood pressure)
- Yohimbe is used to increase libido and for ED (raises blood pressure, increases heart rate and has a risk of seizures)
Describe the health risks of caffeine
- Caffeine taken in usual doses is not harmful; in excessive doses, caffeine can raise blood pressure and increase heart rate
- Caffeine is present in supplements for weight loss, energy and body-building (many have high caffeine content)
- Caffeine is present in black tea, green tea, cocoa (including chocolate), yerba mate, guarana and kombucha
- Green tea “extract” (with various unknown contents) has been linked to liver damage in body-building products
Describe the health benefits of caffeine
- Caffeine increases alertness, helps with weight management and can be useful in treating headaches
- Green tea, in reasonable amounts, helps lower LDL and triglycerides
What are medical foods?
They are compounds used to meet a nutritional need, which should be used under medical supervision, yet not all require a prescription
What are the FDA requirements for Medical Foods?
- Taken enterally (by mouth or with enteral feeding tube)
- Taken under supervision of a health care professional
- Intended to treat a condition with a known nutritional requirement
What are some commonly used medical foods?
Commonly used medical foods include L-methylfolate, used for depression, L-methylfolate, B6 and B12 (Metanx) used for neuropathic pain and phosphatidylserine conjugated to different forms of enriched omega-3 fatty acids used for mild cognitive impairment and ADHD
