What You Need to Know About Herbal Medications

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As the elderly population in the United States grows, the number of prescriptions being filled in the U.S. is increasing dramatically. Because of media hype and disappointment with current conventional medications, more patients are turning to alternative treatments such as herbal products.

In the year 2000, the U.S. spent more than $5 billion on herbal medications. Additionally, 1 out of every 3 people in the U.S. will use at least one form of alternative medication. It is important to note that the U.S. Food and Drug Administration (FDA) has no established definition for an herbal supplement. Although traditionally used as drugs, herbal products are generally unable to pass the stringent requirements imposed by the FDA for new molecular entities, such as new medications.

The Dietary Supplement Health and Education Act (DSHEA) of 1994 prohibits the FDA from the regulation of dietary supplements as food additives. Thus, it is extremely important that patients talk to their health care providers before purchasing and taking any over-the-counter or herbal medication. This is especially true if the patient is on multiple prescription medications.

It is very important to tell your health care professional about your past medical history and medication history. An estimated 70 percent of patients do not inform their doctors about the use of alternative therapies, causing 15 million Americans to be at risk for potential drug-dietary supplement interactions.

The information you tell your doctor should include: a list of all your allergies, an updated list of all your medications (prescription, over-the-counter and herbals), if you are having problems taking your medications, or if you are or plan to become pregnant.

Patients should not be afraid to ask their doctors or pharmacists any questions they may have about their medications, such as side effects, food interactions, drug interactions, and how and when to take their medications. The open communication will decrease the likelihood of a potential drug interaction and, hopefully, encourage medication compliance, which can lead to overall improved patient care and satisfaction.

What are herbal medications?

Herbal medications are products derived from plant parts that cause a pharmacologic effect (like a medicine).

Are herbal medications safe?

There are a few general cautions to follow when taking herbal medications:

  • Use herbs with caution if you are taking prescription medications. Always ask a health care provider to review your medications for any potential herb-drug interactions.

  • Because they contain a variety of chemical components, many herbs may cause temporary adverse effects such as nausea, vomiting and gastrointestinal upset.

  • Large doses of herbs may increase the potential of adverse effects.

Common sense dos and don'ts

DO:

  • Buy only preparations in which the plant ingredients are listed on the packet.

  • Tell your health care provider about any herbal remedy or alternative medicine you may be taking, and watch out for side effects and drug interactions.

  • Be careful about taking similar types of herbs if you have allergies to certain plants, pollen or flowers.

  • Beware of false claims. Many herbal preparations are sold by people who have limited clinical knowledge.

DON'T:

  • Do not take herbal products if you are pregnant or attempting to become pregnant.

  • Do not give herbal products to infants or children.

  • Do not take large quantities of any one herbal preparation.

Are there any regulations on herbal supplements?

In 1994, the Dietary Supplement Health and Education Act (DSHEA) was passed. The DSHEA defined dietary supplements as vitamins, minerals, herbs, botanicals or amino acids used to supplement the diet to increase total dietary intake.

According to the DSHEA, the U.S. Food and Drug Administration (FDA) is prohibited from regulating dietary supplements as food additives. Makers of dietary supplements are permitted to make structure and function claims, but not therapeutic claims. For example, a St. John's wort product can claim to enhance mood, but it cannot state that it treats depression. In addition, all dietary supplements must have the following warning about the functional claims: "This statement has not been evaluated by the Food and Drug Administration."

What does it mean if a product claims to be standardized or to have guaranteed potency?

"Standardized" or "guaranteed potency" means the botanical extract has been analyzed for and contains a certain, known level of components (within a range of +/- 10 percent). These components help your health care provider have confidence that the chosen product will have a standard for effectiveness and quality.

Keep in mind that not all herbals are standardized. It is difficult to identify ingredients, and the active ingredient may not be present. For example, contamination or environmental conditions--such as temperature, rainfall, altitude and soil--can affect the quality and concentration of the active ingredient plant.

Are there any "unsafe" herbs?

There are some herbs that are considered unsafe in particular situations:

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n Licorice -- This is used for ulcers, as an expectorant and for cancer prevention. It is unsafe for use in people who have cirrhosis, kidney disease and heart disease, as well as in women who are pregnant. To minimize the risk of adverse effects, licorice should be used for no longer than 6 weeks.

n Ephedra -- Ephedra is used as a decongestant and anorexiant (appetite suppressant), as well as for allergies, asthma and depression. It is a component of the herbal phen-fen, and has been associated with increased blood pressure, as well as an increased incidence (frequency) of tremors, seizures, stroke, heart attacks and even death.

Issues to consider when using herbal supplements:

Following are some issues to consider before using herbal supplements:

  • What prescription and non-prescription (over-the-counter) medications are you taking?

  • What other dietary supplements are you taking?

  • Are there any potential interactions--either with drugs or other supplements--when using this supplement?

  • What is the appropriate dosage of this product?

  • What is the appropriate dosage amount and length of therapy for this product?

  • What are the contraindications (inadvisable uses) for this particular dietary supplement?

  • Can this supplement be used during pregnancy and breastfeeding?

  • What is the appropriate children's dosage, if applicable?

Herb/Drug interactions (HDIs)

Seventy percent of patients do not inform their doctors about the use of alternative therapies. (Herbal Medicinals: A Clinician's Guide ) Recent reports show that 18 percent of adults in the United States use prescriptions drugs concurrently with herbal or vitamin products, placing as estimated 15 million Americans at risk for potential drug-dietary supplement interactions. (Natural Therapeutics Pocket Guide 2000-2001)

Adverse reactions to herbal therapies may be related to one or more components of the plant, or to an inappropriate or incorrect manufacturing process. The FDA does not require the reporting of adverse drug reactions; for example, ephedra being associated with increased blood pressure, strokes, heart attack or sudden death.

Tips for consumers:

  • Rely on established, authoritative books on herbs that are based on factual information.

  • Consult a physician or other health care professional who is knowledgeable about herbs to avoid potentially dangerous side effects and interactions.

  • Ask a pharmacist or other health care provider for product information, recommended doses, and information on side effects and effectiveness of herbal remedies.

  • Read labels; look for products that are "standardized."

  • Do not use supplements during pregnancy or while breastfeeding, except with the advice of a physician.

Case study:

Mrs. Jones has heard some reports in the media regarding the use of the herbal supplement hawthorn for heart problems. She has hypertension (high blood pressure) and is taking an ACE inhibitor and a beta-blocker. She decided to go to her local pharmacy that sells hawthorn. Mrs. Jones asks the appropriate questions: "Which hawthorn product should I choose?" "Should it be standardized or not?" "Can I take this herb with my heart medications?"

It is crucial that Mrs. Jones be able to obtain appropriate information from a trained health care professional. In Mrs. Jones' case, the problem is that hawthorn has been reported to have ACE-inhibiting properties that may increase the effects of her current ACE inhibitor.

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This information is provided by the Cleveland Clinic and is not intended to replace the medical advice of your doctor or health care provider. Please consult your health care provider for advice about a specific medical condition. For additional written health information, please contact the Health Information Center at the Cleveland Clinic (216)

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