Dangerous
Combinations

Understanding the
risks of mixing
herbal products and drugs

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National Center for Complementary and Alternative Medicine

Scientific Review of Alternative Medicine

Center for drug evaluation and research

 

Supplements with FDA Warnings

In 1993, the FDA published a list of dietary supplements it considers hazardous. The categories of dietary supplements include vitamins, minerals, botanicals, high-potency free amino acids, enzymes, animal extracts, and bioflavanoids. Unlike prescription drugs, dietary supplements enter the marketplace without undergoing a safety review by the FDA. In 1993, the FDA initiated efforts to collect and evaluate existing studies and case reports on safety problems associated with dietary supplements. A list of selected dietary supplements associated with serious safety problems follows. This list is condensed and is not intended to include all hazardous ingredients in dietary supplements. For a complete list of dietary supplements and the safety problems associated with them, contact the FDA for a copy of the article, "Unsubstantiated Claims and Documented Health Hazards in the Dietary Supplement Marketplace."

I. Herbals. Herbal and other botanical ingredients of dietary supplements include processed or unprocessed plant parts (bark, leaves, flowers, fruits, and stems), as well as extracts and essential oils.

  • Chaparral (Larrea tridentata)
  • Comfrey (Symphytum officinale)
  • Yohimbe (Pausinystalia yohimbe)
  • Lobelia (Lobelia inflata)
  • Germander (Teucrium genus)
  • Willow bark (Salix species)
  • Jin bu huan
  • Stephania and Magnolia species
  • Ma huang

II. Amino acids

  • L-tryptophan
  • Phenylalanine

III. Vitamins and minerals. Certain vitamins and minerals that are safe when consumed at low levels are toxic at higher doses.

  • Vitamin A
  • Vitamin B6
  • Niacin (nicotinic acid and nicotinamide)
  • Selenium

IV. Other products

  • Germanium

~ Nancy Devine

 

By Nancy Devine
April 10, 2000
Photos: Photodisc

In pursuit of improved health, many Americans take herbal supplements available everywhere from the grocery store to the Internet. A 1998 study in the Journal of the American Medical Association (JAMA ) reported that 15 million consumers take dietary supplements, and 18 percent combine supplements with their prescription medicine.

But interactions between herbal products and synthetic medicines have been linked to serious injuries and an estimated 184 deaths. As a result, pharmacists, nutritionists, and nurses are scrambling to learn about combinations that may endanger their patients’ health.

"We’re asking patients more aggressively about what dietary supplements or even what home remedies they’re taking," said Jim Strunk, a pharmacist at Public Health Service Indian Hospital, in Albuquerque, N.M. "A good example is ephedrine. Somebody with a high thyroid taking meds to keep it low who then takes a product with ephedrine will speed up their heart rate. It’s dangerous."

Ma huang is one of several names for herbal products containing members of the genus Ephedra, which has been linked to more than 500 serious adverse effects reported to the Food and Drug Administration – including 38 deaths – resulting in hypertension, nerve damage, psychosis, and stroke. Another herb, St. John’s wort (Hypericum perforatum), often taken to reduce depression or anxiety, has been demonstrated in a study to interact with the HIV-protease inhibitor indinavir, and cyclosporine, a drug used to prevent organ transplant rejection. The herb significantly reduced the effectiveness of both drugs.

Federal oversight

The FDA created a monitoring system and has been tracking what it terms "adverse events of herbal supplements" since the passage of the Dietary Supplement Health and Education Act (DSHEA) in 1994. "Our monitoring system is ongoing, we just don’t have the funding to make the reports available to the public in real time, the way we’d like to," said Brad Stone, FDA press spokesman. "Of course when there’s a significant drug interaction, we put out an advisory."

Other FDA officials concede that the herbal tracking system suffers from low funding, even though it is part of the FDA’s MedWatch program for FDA-regulated drugs and medical products.

"The FDA monitors to the best of their ability, but they don’t have the funding, staff, or expertise to cover the bases," said Steven Foster, co-author with Varro Tyler of Tyler’s Honest Herbal, a standard reference containing a scientific review of herbs for laypeople and pharmacists. "It’s incumbent upon consumers and healthcare practitioners to be armed with information on these dietary supplements. Health professionals are experiencing a cart-before-the-horse situation because the products have leapt onto the shelves before practitioners have had a chance to take a CE course, except for those who graduated in the late ’60s."

Foster, who also is president of Steven Foster Group Inc., a Fayetteville, Ark.-based consulting company that collects information about herbs, recommended health professionals review authoritative information via the online database for the National Library of Medicine, which contains almost 3,500 medical journals dating back to 1966.

"Most pharmacies operate on computerized systems with programs that detect drug interactions, but to check an herbal supplement you usually need to go to a different system," said Victor Padron, PhD, associate professor of pharmaceutical sciences at Creighton University in Omaha, Neb. "Changes and conflicting information come in faster than updating can occur, and many pharmacists are pedaling as fast as they can to keep up. More systematic documentation of interactions is needed, but here’s the fear: Congress went through great pains to create a loophole in the DSHEA to allow these supplements to be sold, all because of the cry from the public. Now health professionals are afraid it will take some huge tragedy to happen before regulation can occur, and when it does, some sledgehammer regulation will be put in where perhaps a tweezer-sized one would have done the job."

Nurse intervention

Nurses may not be current on all harmful drug interactions, but they can play a pivotal role in preventing medical tragedies. "Remember that according to JAMA, only about three in 10 patients tell their physicians what they’re taking," said Padron. "Nurses can engage patients in a discussion of what supplements they’re taking and then provide guidance and education."

But are nurses asking patients about herbal supplements? Have they learned about potentially harmful interactions?

"We ask patients what kinds of herbal supplements they’re taking, and for how long," said Lita Tsai, MA, RN, chief nursing officer at Pacific Alliance Medical Center in Los Angeles. "That’s part of our patient assessment tool for the preop checklist. We have many Asian patients and physicians, so we ask. I’m very interested in herbal supplements, so I read about them."

Not all facilities have similar policies. "We ask patients what prescription drugs they’re taking and if they have allergies," said Connie Taylor, MPA, RN, patient care policy and procedure coordinator at Stanford Hospital and Clinics. "I’d like to say that we ask about herbals, but it’s not a requirement. It will happen at the bedside when [the Joint Commission on Accreditation of Healthcare Organizations] makes it a standard. But the issue presents a great opportunity for nurses to help their patients."

Health experts agree that interest in dietary supplements is driven more by consumers with limited medical knowledge than by health practitioners. "People say herbs are plant products and therefore safe and natural, but we all know as nurses that’s not true," said Denise Jacob, PhD, RN, president of Health Decision Resources, a Birmingham, Mich.-based company that helps patients understand their diagnoses and research their treatment options – including herbal therapy. "Take Lanoxin or digitalis. It’s derived from foxglove, but is an extremely potent heart medicine with a narrow therapeutic range. Just because it’s natural doesn’t mean it’s innocuous."