CHICAGO – Nearly one in five people who take prescription medications also take herbal or mineral supplements, soemphasized Cora Breuner, MD, MPH, a professor of pediatrics at the University of Washington in Seattle.
“In chronically ill children, almost 80% to 90% of kids are using supplements, so it’s really almost imperative that this be asked when you’re taking your histories, not in the social history, but when you’re asking about medications,”
Providers also should be familiar with the evidence base for complementary and alternative medicine (CAM). According to the , 11.6% of those aged 4-17 years had taken or used some type of complementary health product within the previous year. Fish oil/omega-3 fatty acid supplements, melatonin, probiotics/prebiotics, and echinacea topped the list.
“For children, complementary approaches were most often used for back or neck pain, other musculoskeletal conditions, head or chest colds, anxiety or stress, attention-deficit hyperactivity disorder [ADHD], and insomnia or trouble sleeping,” Dr. Breuner said.
Regulation of herbal and other supplements
Dietary supplements, including vitamins, minerals, and herbal remedies, are regulated under the Dietary Supplement Health and Education Act of 1994 (DSHEA) – not the Food and Drug Administration. Not only can products enter the market without any testing for efficacy, but companies only have to provide “reasonable assurance” of a product’s safety, not proof.
“Supplements do not have to be manufactured according to any standards,” Dr. Breuner said, although reputable manufacturers support standards. “It’s basically up to the company that manufactures it to make sure the product is not contaminated and that the product is basically consistent. There’s no need whatsoever for the company to make sure it works.”
Yet many patients and parents don’t realize that, she said.
“It’s important for people to be aware that this is not a regulated industry per se by the federal government,” she said. “Patients really do think that it is.”
One voluntary quality indicator is the United States Pharmacopeia Dietary Supplement Verification , identified by a USP “dietary supplement verified” logo. also provides an “approved quality” logo, tests samples voluntarily sent by manufacturers, and rates the quality of different brands.
“Supplements may not claim to cure or prevent a disease, but they can say how it affects the body’s structure and function,” she said, and companies do not need FDA approval for packaging or marketing claims. In this low regulatory environment, substantial variations exist in the quality and quantity of biological ingredients in marketed supplements.
Risks from herbal supplements
Dr. Breuner cited a 2011 study finding that 75% of 68 products tested had no key safety messages, including all 12 ginkgo products and all but 1 of the 21 garlic and seven Asian ginseng products tested. Most of the 13 echinacea products also lacked safety messages, but two-thirds of the 12 St John’s wort products did have safety information.
Risks can include contamination, inadequate packaging information, and unknown toxicities and interactions. Adverse reactions should be reported to the Food and Drug Administration’s MedWatch at 800-FDA-1088 (fax: 800-FDA-0178) and to Poison Control at 800-222-1222.
Two popular herbal remedies that are unsafe for children include licorice and ephedra. Although it is used for peptic ulcers, licorice lacks much evidence backing it and also shouldn’t be used (or eaten) during pregnancy. Ephedra (ma huang), an appetite suppressant and decongestant, can cause heart palpitations, heart attacks, and death.
“You can still get ephedra over the Internet, but it’s very, very dangerous,” Dr. Breuner said.
Dr. Breuner listed other herbal products available online but deemed unsafe for children: aconite (also known as bushi), species from the genus Aristolochia, belladonna, blue cohosh, borage, broom, calamus, chaparral, coltsfoot, comfrey, germander, life root, lobelia, pennyroyal, poke root, sassafras, skullcap, tansy ragwort, and wormwood.
Another set of herbs can be dangerous prior to surgery, she said, noting that an estimated 26% of patients scheduled for surgery use herbal products.
“Many, many of the herbs cause platelet aggregation issues,” Dr. Breuner said, so it’s very important to ask about different herbs before surgeries. Patients should discontinue echinacea, ephedra, garlic, ginkgo, ginseng, kava, St. John’s wort, and valerian before surgery. Risks include cardiovascular instability, prolonged sedation, bleeding, electrolyte disturbances, and immunosuppression. Additionally, four supplements also adversely interact with warfarin: garlic, ginger, and feverfew have additive effects (although small dietary amounts of ginger and garlic are fine), and St. John’s wort can decrease warfarin’s effects.
Dr. Breuner urged attendees to use resources like PubMed Dietary Supplement to find out more about supplements; this subset limits results of a PubMed search of citations and abstracts to just those related to dietary supplements. It was created through a partnership between the Office of Dietary Supplements and the National Library of Medicine, both parts of the National Institutes of Health.