Dietary supplements drugs

For any intervention intended to impact favorably upon human health, it is important to evaluate its safety and efficacy in order to demonstrate that it does not cause harm and it does provide the expected benefit. The gold standard method for evaluating any intervention, whether it be a botanical product, dietary supplement, drug, medical device or medical procedure, is the randomized, clinical trial (RCT). A clinical trial is a type of experiment conducted in human subjects where the effects of at least two interventions are compared. Often, the clinical trial takes the form of an active treatment compared to an inactive control or placebo. 

Drug-Drug, Drug-Dietary Supplement, Drug-Citrus Fruit, and Other Food I nteractions—Label ing I mpl ications... 

Smolinske, S.G. 1999. Dietary supplement-drug interactions.. Am. Med. Womens Assoc. 54(4) 191-195. 

Gardiner P, Phillips R, Shaughnessy AF. Herbal and dietary supplement - drug interactions in patients with chronic illnesses. Am Fam Physician. 2008 77 73-8. 

An issue that has become of concern is the interaction of dietary supplements with herbs and other dietary supplements, drugs, foods, lab tests, and diseases or other conditions. There are literally hundreds of potential interactions that have not yet been recognized. Both practitioners and consumers must be aware of the possibilities. In some cases. 

When obtaining the drug history, the nurse must always question the patient about the use of herbs, teas, vitamins, or other nutritional or dietary supplements. Many patients consider herbs as natural and therefore safe It is also difficult for some to report the use of an herbal tea as a part of the health care regimen. Display 1-4 identifies teaching points to consider when discussing the use of herbs and nutritional supplements with patients. Although a complete discussion about the use of herbs is beyond the scope of this book, it is important to remember that the use of herbs and nutritional supplements is commonplace in many areas of the country. To help the student become more aware of herbal therapy and nutritional supplements, Appendix B gives... 

The EVA warns the public not to take ephedrine-contain-ing dietary supplements with labels that portray the products as an alternative to illegal street drugs such as Ebsta because these products may pose serious health risks to consumers... 

Conduct a medication history (prescription, over-the-counter, and dietary supplements) to determine conditions or causes of hypertension. Does the patient take any medications, supplements, herbal products, or foods that may elevate SBP or DBP Does the patient have drug allergies ... 

Inform the patient about the potential drug-drug interactions with warfarin, including over-the-counter medications and dietary supplements (Tables 7-8, 7-9, and 7-10). Instruct the patient to call the health care practitioner responsible for monitoring warfarin therapy before starting any new medications or dietary supplements. 

Medication use must be monitored carefully for potential hepatotoxicity. Hepatically metabolized medications have the potential to accumulate in patients with liver disease. Little guidance is available on drug dosing in hepatic impairment because these patients are often excluded from drug trials. Daily acetaminophen use should not exceed 2 g. Dietary supplements have not been well studied in hepatic impairment and cannot be recommended. 

Obtain a complete history of alcohol intake and hepato-toxic drug use, including over-the-counter products and dietary supplements. 

Obtain a thorough medication use history, including present and past drugs prescription and nonprescription drugs the patient s self-assessment of response and side-effect problems use of alcohol, tobacco, caffeine, and illicit substances and use of herbal products and dietary supplements, as well as any allergies and adherence difficulties. 

Several studies have evaluated dietary supplements such as isoflavones, which are found in soy products and red clover. A well-controlled trial in more than 400 postmenopausal women evaluating a specific isoflavone, ipriflavone, found no benefits on bone mineral density or fracture rates after 3 years.47 Nevertheless, because these therapies are available without prescription and are not regulated by the FDA, patients may choose to self-medicate with isoflavones. Lymphocytopenia appeared in several patients treated with ipriflavone in clinical trials. Additionally, ipriflavone should be used with caution in immunocompromised patients or those with renal disease. It may inhibit CYP1A2 and CYP2C9 and may interact with drugs metabolized by those pathways, such as warfarin. 

Obtain a thorough medication history, including prescription drugs, over-the-counter drugs, and dietary supplement use. 

Obtain a complete medication history, including history of prescription drug, nonprescription drug, and dietary supplement use. Determine if the patient has used any successful or unsuccessful treatments for this condition in the past. 

The above illustration should be a clear caution that components of food may interact with drugs, resulting in substantial positive or negative therapeutic effects. As will be noted later, this principle also applies to so-called dietary supplements, including bo-tanicals, used for the treatment of numerous medical conditions. 

In addition to food- or nutrient-based interactions in the metabolism of drugs, it has become quite clear in recent years that so-called dietary supplements including botanicals have the potential to participate in such interactions. The latter observation has special relevance because of the extensive use of such products worldwide ( 12 billion per year in the United States alone), their easy commercial availability (no prescription required), and their common use with prescribed drugs. Furthermore, many people consider such natural products to be safe and free of any bad effects (it should be pretty easy to recall many poisons... 

By the year 2010, FDA will have a science-based regulatory program that fully implements the DSHEA. The plan addresses safety, labeling, clarification of the differences between drugs and dietary supplements, and enforcement activities. 

Although many patients believe that dietary supplements will not interact with medications, recent literature suggests otherwise. Recently, many St. John s wort-drug interactions have been reported in the literature. Cases of patients developing symptoms of serotonin syndrome have been reported with St. John s wort alone and in concomitant therapy with other antidepressants such as monoamine oxidase inhibitors, serotonin reuptake inhibitors, and venlafaxine. St. John s wort may exacerbate the sedative effects of benzodiazepines, alcohol, narcotics, and other sedatives. St. John s wort may decrease the levels of protease inhibitors, cyclosporine, digoxin, and theophylline. 

Legal principles in the area of dietary supplements are not well established. Some believe that liability should be the same for dietary supplements as it is for prescription and pharmacist-recommended non-prescription drugs [55]. 

FDCA defines drugs as articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and articles (other than food) intended to affect the structure or any function of the body. Therefore, a product becomes a drug based upon its intended use and not upon its composition or source [26]. A pharmacist may violate the FDCA if he or she recommends and sells a dietary supplement for the treatment of a particular disease—the pharmacist would be indicating the product as an unapproved drug. However, if the pharmacist is not selling the product, the FDCA would not be violated. 

If a pharmacist posted a sign in a pharmacy claiming a dietary supplement is effective in treating or preventing a certain disease, the pharmacist would be violating the FDCA. The product would be considered a drug but not properly labeled as a drug and therefore would be misbranded. 

Natural and herbal diet pills available in the United States today are considered dietary supplements and are not subject to FDA review prior to being sold. Although these agents may have drug-like activity in the body, they do not need to be proven safe or effective like conventional drugs do. Unlike conventional drugs, natural and herbal diet pills can only be withdrawn from the market when they are proven to be dangerous. As a result, many herbal products reach the market without any scientific evidence that they are safe or effective. These products are discussed in more detail in Chapter 6. 

What defines a dietary supplement versus a drug As defined by Congress in the Dietary Supplement Health and Education Act (which became law in 1994), a dietary supplement is a product (other than tobacco) that ... 

One distinction between drugs and dietary supplements is how they are regulated by the FDA. Unlike for drugs, manufacturers do not have to provide FDA with evidence that dietary... 

Unlike with drugs, manufacturers of dietary supplements do not have to disclose potential side effects of their products to consumers. The label of the supplement may contain a cautionary statement, but the lack of such a statement does not mean that no adverse effects are associated with the product. Dietary supplements may also interfere with the activity of other medicines (drugs or other supplements) an individual is taking. Also unlike with drugs, the manufacturer is not required to disclose these interactions to the consumer. 

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