LaGrange,
IL – May 2004 - People are taking over-the-counter herbs (considered
dietary supplements) in greater numbers than ever before, for everything
from general health improvement to chronic conditions like back pain.
Herbs can have benefits; but like prescription drugs, they can also have
unwanted side effects, cause drug interactions and potentially cause
surgical complications. It is important for health care consumers to
educate themselves, so they can avoid unnecessary health risks.
The North American Spine Society (NASS) has created a brochure, Herbal Supplements: “Natural” Doesn’t Always Mean Safe, to help consumers learn about the safe and unsafe uses of herbs. Many herbs have drug-like effects and even those that are generally safe can be dangerous or have side effects under certain conditions. For example, herbs can interact with anesthesia or other medicines in surgery, or cause excessive bleeding. Drug-herb interactions unrelated to surgery are also common. According to a study in the Journal of the American Medical Association, roughly 15 million adults are at risk for possible adverse interactions between prescription drugs and herbs or high dose vitamins.
NASS’ educational brochure provides:
NASS’ patient education brochure on herbal supplements can be purchased by healthcare providers in packs of 25 and can be found on the NASS Web site or by contacting the North American Spine Society at (630) 230-3600.
NASS is a multidisciplinary medical organization dedicated to fostering the highest quality, evidence-based, and ethical spine care by promoting education, research, and advocacy. Since its start in 1985, NASS has grown to nearly 4,000 members in 22 spine-related specialties. NASS members are MDs, DOs, and PhDs, including orthopedics, neurosurgery, physiatry, pain management, and other disciplines. Nurse practitioners, physician’s assistants, chiropractors, physical therapists, practice administrators, and other allied health care professionals involved in spine care are also represented as affiliate members.
For further information, contact:
North American Spine Society
Toll-free: (866) 960-6277 Direct: (630) 230-3600
The North American Spine Society (NASS) has created a brochure, Herbal Supplements: “Natural” Doesn’t Always Mean Safe, to help consumers learn about the safe and unsafe uses of herbs. Many herbs have drug-like effects and even those that are generally safe can be dangerous or have side effects under certain conditions. For example, herbs can interact with anesthesia or other medicines in surgery, or cause excessive bleeding. Drug-herb interactions unrelated to surgery are also common. According to a study in the Journal of the American Medical Association, roughly 15 million adults are at risk for possible adverse interactions between prescription drugs and herbs or high dose vitamins.
NASS’ educational brochure provides:
- Background on herbal supplements
- Tips for safe use (ie, the belief “if one is good, more must be better” can be downright dangerous) and potential adverse effects
- Instructions on reporting adverse events and searching the Internet for credible information
NASS’ patient education brochure on herbal supplements can be purchased by healthcare providers in packs of 25 and can be found on the NASS Web site or by contacting the North American Spine Society at (630) 230-3600.
# # #
NASS is a multidisciplinary medical organization dedicated to fostering the highest quality, evidence-based, and ethical spine care by promoting education, research, and advocacy. Since its start in 1985, NASS has grown to nearly 4,000 members in 22 spine-related specialties. NASS members are MDs, DOs, and PhDs, including orthopedics, neurosurgery, physiatry, pain management, and other disciplines. Nurse practitioners, physician’s assistants, chiropractors, physical therapists, practice administrators, and other allied health care professionals involved in spine care are also represented as affiliate members.
For further information, contact:
North American Spine Society
Toll-free: (866) 960-6277 Direct: (630) 230-3600
People are taking over-the-counter herbs (considered a form of dietary supplement) in greater numbers than ever before. You, or someone you know, may be taking one right now. People take herbs for many reasons from general health improvement to care of chronic conditions, including back pain. According to US News and World Report, Congress’ General Accounting Office estimated consumer spending for dietary supplements and functional foods to be about $31 billion in1999.
“Natural” Doesn’t Always Mean Safe
Like prescription medicines, herbs can have benefits. However, like prescriptions, they can also have unwanted side effects, cause drug interactions and possibly create surgical problems. Large doses of herbs (the belief that “if one is good, more must be better”) can be dangerous.
Many herbs have drug-like effects on the body. The many chemical components in herbal products may have varied strengths based on plant genetics, plant parts and growing conditions. Herbs have many components that may also work together differently based on harvesting, processing or packaging. Contamination also can take place during production. For example, heavy metals have been found in some Asian herbal products. Even herbs that are generally safe can be dangerous or have side effects under the wrong conditions. For instance, herbs can act together with anesthesia or other medicines commonly used in surgery or affect the operation itself, causing surgical complications.
Drug-herb interactions unrelated to surgery are also common. Many supplements contain active ingredients that have strong biological effects and are not safe for everyone. According to a study in the Journal of the American Medical Association (JAMA), roughly 15 million adults are at risk for possible adverse interactions between prescription medicines and herbs or high dose vitamins. More than 2900 adverse events related to supplements have been reported to the Food and Drug Administration (FDA), including 104 deaths. The FDA estimates that for each report it receives, there are 100 more it doesn’t. Much of the material in this pamphlet can be found in the FDA Center for Food Safety and Applied Nutrition document, Tips for the Savvy Supplement User: Making Informed Decisions and Evaluating Information.Should I Ask My Doctor Before Using a Supplement?
Checking with your doctor before taking a supplement is a good idea, especially for certain people. Dietary supplements including herbs may not be risk-free under certain circumstances. If you are pregnant, nursing a baby or have a chronic medical condition (such as diabetes, hypertension or heart disease) consult your doctor or pharmacist before purchasing or taking any supplement. While vitamin and mineral supplements are widely used and generally considered safe for children, you may wish to check with your doctor or pharmacist before giving these or any other dietary supplement to your child. If you plan to use a dietary supplement in place of drugs or together with any drug, tell your health care provider first. If you have certain health conditions and take these products, you may be placing yourself at risk. Bring your herbal or other dietary supplements with you to doctor visits. Your health care provider can review your supplements with you and tell you about any possible problems or risks.
Some dietary supplements may interact with prescription and
over-the-counter medicines
Combining supplements or using supplements together with medicines (prescription or over-the-counter) could under certain circumstances produce undesirable effects, some life-threatening. Be alert to warnings about these products, whether taken alone or in combination. For example, Coumadin (a prescription medicine), gingko biloba (an herb), aspirin (an over-the-counter drug) and vitamin E (a vitamin) can each thin the blood, and taking any of these products together can increase the potential for internal bleeding. Combining St. John’s Wort with certain HIV drugs signifi antly reduces their effectiveness. St. John’s Wort may also reduce the effectiveness of prescription drugs for heart disease, depression, seizures, certain cancers or birth control pills.
Some dietary supplements can have unwanted effects during surgery. It is important to tell your doctor about vitamins, minerals, herbs or any other supplements you are taking, especially before surgery. You may be asked to stop taking these products at least 2-3 weeks before an operation to avoid potentially dangerous supplement/drug interactions—such as changes in heart rate, blood pressure and increased bleeding— that could negatively affect your surgery.
Other Safety Tips…
- Do not take larger than recommended doses of herbs.
- Elderly people should not take herbs without the approval of a doctor. It is a good idea for everyone to check with their health care provider before taking dietary supplements.
- Avoid long term use of herbs (more than several weeks).
- Take time to study about your supplements so you know about them and can avoid problems.
Reporting Adverse Effects
Adverse effects from using dietary supplements should be reported to MedWatch (the program for reporting problems with FDA-regulated products).
You, your health care provider, or anyone may report a serious adverse event or illness to the FDA if you believe it is related to the use of any dietary supplement product. The FDA would like to know when you think a product caused a serious problem, even if you are not sure that the product was the cause or do not visit a doctor or clinic. In addition to telling FDA online or by phone, you may use the MedWatch form available from the FDA Web site.
Telephone: 1-800-FDA-1088
Fax: 1-800-FDA-0178
(using a MedWatch reporting form)
Online: http://www.fda.gov/medwatch/how.htmPossible Side Effects and Interactions
This list is a sample and does not contain all herbs that may cause the listed or other conditions or hazards. All herb use should be approved by a health care provider.
Possible Risk of Increased Bleeding (Especially with Surgery)
Chamomile Dong Quai
Feverfew Fish Oil
Garlic Ginger
Gingko Ginseng
St. John’s Wort Vitamin E
May Worsen Swelling (Edema) and/or HighBlood Pressure (Hypertension)
Celery Dandelion
Elder Goldenseal
Guaiacum Juniper
Interacts with Nonsteroidal Antiinflammatory Drugs (prescription and over-the-counter pain relievers including aspirin, Advil®, Motrin® and Aleve®)
Feverfew Gingko
Ginseng St. John’s Wort
Uva-Ursi
More Information About Supplements
Who is responsible for safety and effectiveness of dietary supplements?
By law, manufacturers of dietary supplements are responsible for making sure their products are safe before they go to market. They are also responsible for making sure that the claims on their labels are accurate and truthful. The government does not review dietary supplements before they are marketed, but the FDA is responsible for taking action against any unsafe supplement product that reaches the market.
Searching the Internet for Information
When searching the Web for information on dietary supplements, try using directory sites of respected organizations rather than blind searches with a search engine. Ask yourself these questions:
- Who operates the site?
Is the site run by the government, a university, or a reputable medical or health-related association (eg, American Medical Association, American Diabetes Association, American Heart Association, National Institutes of Health, National Academies of Science, or the US Food and Drug Administration)? Is the information written or reviewed by qualified health professionals, experts in the field, academic world, government or the medical community? - What is the purpose of the site?
Is the purpose of the site to objectively educate the public or just to sell a product? Be aware of practitioners or organizations whose main interest is selling products, either directly or through linked sites. Commercial sites should clearly distinguish scientific information from advertisements, but do not always do so. Most nonprofit and government sites contain no advertising, and access to the site and materials is usually free. - What is the source of the information and does it have any references?
Has the study been reviewed by recognized scientific experts and published in reputable peer-reviewed scientific journals, like the New England Journal of Medicine? Does the information say “some studies show…” or does it tell where the study is listed so that you can check the authenticity of the references? For example, can the study be found in the National Library of Medicine’s database of literature citations (PubMed link- http://www.ncbi.nlm.nih.gov/PubMed/) - Is the information current?
Check to see when the material was posted or updated. Often new research or other findings are not reflected in old material, eg, side effects or interactions with other products or new evidence that might have changed earlier thinking. Ideally, health and medical sites should be updated frequently. - How reliable is the Internet or e-mail solicitations?
While the Internet is a rich source of health information, it is also an easy way to spread myths, hoaxes and rumors about supposed news, studies, products or findings. To avoid such hoaxes, be skeptical and watch for very emphatic language with UPPERCASE LETTERS and lots of exclamation points!!!! Beware of such phrases as: “This is not a hoax” or “Send this to everyone you know.” - Contact the manufacturer for more information about the specifi c product you are purchasing
If you cannot tell whether the product you are purchasing meets the same standards as those used in the research studies you read about, check with the manufacturer or distributor. Ask to speak to someone who can address your questions, some of which may include:
What information does the firm have to substantiate the claims made for the product? Be aware that sometimes firms provide so-called “proof” of their claims by citing undocumented reports from satisfied consumers or “internal” graphs and charts that could be mistaken for evidence-based research.Additional Safety Tips
Does the firm have information to share about tests it has conducted on the safety or efficacy of the ingredients in the product?
Does the firm have quality control systems in place to determine if the product actually contains what is stated on the label and is free of contaminants?
Has the firm received any adverse event reports from consumers using their products?
- Ask yourself: Does it sound too good to be true?
Do claims for the product seem exaggerated and unrealistic? Are simple conclusions drawn from a complex study to sell a product? While the Web can be a valuable source of accurate, reliable information, it also has a wealth of misinformation that may not be obvious. Learn to distinguish hype from evidence-based science. Nonsensical jargon can sound very convincing. Also, be skeptical about anecdotal information from people who have no formal training in nutrition or herbal supplements, or from personal testimonials (eg, from store employees, friends or on-line chat rooms and message boards) about incredible benefits or results. Question these people about their training and knowledge in nutrition or medicine. - Think twice about chasing the latest headline.
Sound health advice is generally based on a body of research, not a single study. Be wary of results claiming a “quick fix” that depart from previous research and scientific beliefs. Keep in mind science does not advance by dramatic breakthroughs, but by taking many small steps, slowly building toward agreement. Also, news stories about the latest scientific study, especially on TV or radio, are often too short to include important details that may apply to you or allow you to make an informed decision. - Check your assumptions about these statements:
Even if a product may not help me, it at least won’t hurt me. Don’t assume this is always true. When consumed in high enough amounts, for a long enough time, or together with certain other substances, all chemicals can be toxic. This includes nutrients, plant components and other biologically active ingredients.
When I see the term “natural,” it means that a product is healthful and safe. Consumers can be misled if they assume this term assures wholesomeness, or that these food-like substances have milder effects, which makes them safer than drugs. The term “natural” on labels is not well defined and sometimes used vaguely to suggest unproven benefits or safety. For example, many weight loss products claim to be “natural” or “herbal,” but this doesn’t necessarily make them safe. Their ingredients may act together with drugs or may be dangerous for people with certain medical conditions.
A product is safe when there is no cautionary information on the product label. Dietary supplement manufacturers may not necessarily include warnings about potential adverse effects on the labels of their products. If consumers want to know about the safety of a specific supplement, they should contact the manufacturer of that brand directly. It is the manufacturer’s responsibility to determine that the supplement it produces or distributes is safe and that there is substantiated evidence that the label claims are truthful and not misleading.
A recall of a harmful product guarantees that all such harmful products will be immediately and completely removed from the marketplace. A product recall of a dietary supplement is voluntary and while many manufacturers do their best, a recall does not necessarily remove all harmful products from the marketplace.
Posted by Orac on April 11, 2012
Repeat after me one more time: Just because something is natural
does not necessarily mean it’s effective or, more importantly, safe. If
there’s one thing common among virtually all purveyors of “alternative”
medicine, it’s that they fetishize anything they consider “natural.” To
them, “natural” is always better. At the very least it’s better than
those evil big pharma-produced purified drugs that they so distrust. Of
course, often forgotten in all of this is that any herbal remedy that
does anything at all from a physiological standpoint to reverse disease
or make you feel better does so because it contains chemical compounds
that are responsible for that aforementioned physiological effect. That
is, I must remind you, the very definition of a drug. Yes, herbs can be
drugs. They’re impure drugs with highly variable content of the active
ingredient, but they’re drugs nonetheless.
And drugs can have side effects. Sometimes those side effects are long term.
I was reminded of this yet again (as if I need to be reminded) by a story that I saw coming across the wires yesterday entitled Herbal remedy blamed for high cancer rate in Taiwan: study:
Naturally, when I started to see news reports about this herb, there was only one thing for me to do. That’s right. I had to go to the original study and find out what the skinny is about this herb. It turns out that the specific cancer associated with AA is known as urothelial carcinoma of the upper urinary tract (UUC). Basically, its a cancer of the epithelial lining of the kidney and upper ureter. The authors took advantage of the observation that the place with the highest incidence of UUC in the world is Taiwan. Making the link between such a high incidence of UUC and high usage of AA by the population, the authors were able to test the hypothesis that it is AA that is driving the high levels of UUC in Taiwan. As the authors note, it’s not an unreasonable hypothesis at all:
So how do we put the two together? How do we make the link between AA and UUC in such a way that we can infer causation. Obviously, we can’t do a randomized controlled study in which half the subjects are given AA and the other half a placebo and then wait a decade or so for AA-caused cancers to start to crop up so that we can see if there is an increased incidence of them in subjects in the AA group. Damn ethics! We can, however, infer the likelihood of causation from epidemiological evidence, which is what the authors did. They undertook a molecular epidemiological study.
It turns out that there are good biomarkers for AA exposure. These include aristolactam-DNA (AL-DNA) adducts are due to the binding of AA to DNA and are a sensitive biomarker for AA exposure, particularly given that they concentrate in part of the kidney known as the renal cortex. They also persist for a long time, making them fantastic markers for past exposue. These lesions also lead to a specific mutational signature in the TP53 tumor suppressor gene. This particular mutational signature is characteristic because it is so unusual. Using this mutational signature as a biomarker, the investigators examined 151 Taiwanese patients with UUC. Twenty-five patients with renal cell carcinoma were used as controls. Basically, the authors found that 60% of these patients had mutations that could be due to AA exposure. Everything else fit, as well. Epidemiologically, the incidence of UUC correlated strongly with AA exposure. Biomarkers pinpointed the types of mutations induced by AA. The timing fit, too, in that the increase in UUC in Taiwan was the right length of time after major importation of AA-containing herbal remedies, and the molecular epidemiology fit. All of this led the authors to conclude:
Nature’s a bitch, isn’t she?
It’s hard for me not to repeat this once again; so I won’t even try not to. Instead, I’ll simply reiterate: “Natural” doesn’t mean “good” or “safe,” and herbs can be just as toxic as any medication, even to the point of causing cancer.
And drugs can have side effects. Sometimes those side effects are long term.
I was reminded of this yet again (as if I need to be reminded) by a story that I saw coming across the wires yesterday entitled Herbal remedy blamed for high cancer rate in Taiwan: study:
A toxic ingredient in a popular herbal remedy is linked to more than half of all cases of urinary tract cancer in Taiwan where use of traditional medicine is widespread, said a US study Monday.What amazes me about this is that AA was known to be a powerful nephrotoxin; i.e., it’s toxic to the kidney. It’s the cause of a kidney ailment known as Balkan endemic nephropathy (EN). This was discovered back in the 1950s when it was first described in rural farmers in Bosnia and Herzegovina, Bulgaria, Croatia, Romania and Serbia. Later, in the 1990s, otherwise healthy Belgian women developed renal failure after ingesting Aristolochia herbs as part of a weight loss regime. More reports of kidney toxicity associated with this particular herb kept cropping up, such that the syndrome is now known as aristolochic acid nephropathy (AAN), after the substance from the Aristolochia herb believed to be responsible for the problems.
Aristolochic acid (AA) is a potent human carcinogen that is found naturally in Aristolochia plants, an ingredient common in botanical Asian remedies for aiding weight loss, easing joint pain and improving stomach ailments.
The ancient herb has been touted around the world for thousands of years for everything from gout to childbirth, but scientists now know it carries serious risks of causing kidney disease and urinary cancers.
The latest research found it can interact with a person’s DNA and form unique biomarkers of exposure, as well as creating signals within tumor suppressing genes that indicate the carcinogen has been ingested.
Naturally, when I started to see news reports about this herb, there was only one thing for me to do. That’s right. I had to go to the original study and find out what the skinny is about this herb. It turns out that the specific cancer associated with AA is known as urothelial carcinoma of the upper urinary tract (UUC). Basically, its a cancer of the epithelial lining of the kidney and upper ureter. The authors took advantage of the observation that the place with the highest incidence of UUC in the world is Taiwan. Making the link between such a high incidence of UUC and high usage of AA by the population, the authors were able to test the hypothesis that it is AA that is driving the high levels of UUC in Taiwan. As the authors note, it’s not an unreasonable hypothesis at all:
In Taiwan, the remarkably high incidence ofUUC(13), coupled with widespread use of Aristolochia herbal remedies, suggested that AA might play a central role in the etiology of this disease. The high level of exposure to AA in Taiwan has been documented by a systematic analysis of prescriptions filled by a 200,000 person random sample of the entire insured population of Taiwan between 1997 and 2003, revealing that approximately one-third of these individuals consumed herbs containing, or likely to contain, AA (14). Moreover, consumption of AA is associated, in a dosedependent manner, with an increased risk of developing end-stage renal disease or urothelial carcinoma (13, 15).That’s one popular herbal remedy there.
So how do we put the two together? How do we make the link between AA and UUC in such a way that we can infer causation. Obviously, we can’t do a randomized controlled study in which half the subjects are given AA and the other half a placebo and then wait a decade or so for AA-caused cancers to start to crop up so that we can see if there is an increased incidence of them in subjects in the AA group. Damn ethics! We can, however, infer the likelihood of causation from epidemiological evidence, which is what the authors did. They undertook a molecular epidemiological study.
It turns out that there are good biomarkers for AA exposure. These include aristolactam-DNA (AL-DNA) adducts are due to the binding of AA to DNA and are a sensitive biomarker for AA exposure, particularly given that they concentrate in part of the kidney known as the renal cortex. They also persist for a long time, making them fantastic markers for past exposue. These lesions also lead to a specific mutational signature in the TP53 tumor suppressor gene. This particular mutational signature is characteristic because it is so unusual. Using this mutational signature as a biomarker, the investigators examined 151 Taiwanese patients with UUC. Twenty-five patients with renal cell carcinoma were used as controls. Basically, the authors found that 60% of these patients had mutations that could be due to AA exposure. Everything else fit, as well. Epidemiologically, the incidence of UUC correlated strongly with AA exposure. Biomarkers pinpointed the types of mutations induced by AA. The timing fit, too, in that the increase in UUC in Taiwan was the right length of time after major importation of AA-containing herbal remedies, and the molecular epidemiology fit. All of this led the authors to conclude:
We attribute the progressive increase in the incidence of UUC in Taiwan over the past 25 y, especially among women (Fig. 4), in part to the systematic replacement of traditionally used Mutong and Fangchi herbs with Aristolochia manchuriensis and Aristolochia fangchi, respectively (35, 36). In mainland China, this practice appears to have begun in the 1930s, becoming universal by 1950 and continuing until 2003, when these substitutions were prohibited by the Chinese government (37). The presence of AA in Mutong and Fangchi exported to Taiwan between 1995 and 2003, as well as to other Asian countries, Great Britain, and the Netherlands, has been documented by chemical analysis (38, 39). Thus, assuming a latency period of 20-40 y, an estimate based on the development of AA-associated urothelial carcinomas in Balkan countries (8, 9), the carcinogenic effects of AA would be expected to have become increasingly manifest in Taiwan by 1985 (Fig. 4).Once again, as is often the case, the herbs used in Taiwan come from China. We’ve read time and time again about herbal remedies from China containing mercury and all sorts of toxic metals. This time around it’s a bit different. AA from China isn’t adulterated. Its toxicity is not due to anything external but rather due to chemicals that are naturally part of the plant.
In conclusion, this study provides compelling evidence for the primary role of AA in the etiology of UUC in Taiwan. Importantly, the traditional practice of Chinese herbal medicine in Taiwan mirrors that in China and other Asian countries. Thus, it appears likely that UUC and its attendant AAN also are prevalent in these and in other countries where Aristolochia herbs have long been used for treatment and prevention of disease (1, 5). Because of the lifelong persistence of mutagenic DNA-AL-I adducts in target tissues and irreversible damage to the proximal renal tubules caused by AA, persons treated with Aristolochia herbal preparations at any time in their life are at significant risk of developing UUC or chronic renal disease, thereby creating an international public health problem of considerable magnitude.
Nature’s a bitch, isn’t she?
It’s hard for me not to repeat this once again; so I won’t even try not to. Instead, I’ll simply reiterate: “Natural” doesn’t mean “good” or “safe,” and herbs can be just as toxic as any medication, even to the point of causing cancer.
Natural doesn't always mean safe
Why do people persist in the lazy assumption that anything "natural" is automatically safer than anything man-made?
A beautiful, concise post by the nattily-titled new blogger, Angry Toxicologist, over at ScienceBlogs. He pokes a hole in the lazy assumption that anything "natural" is automatically safe, whereas "chemicals" (which has somehow become a catch-all for anything man-made) are universally bad.
He cites a study in Pharmacoepidemiology and Drug Safety that looked at the safety data for two herbal supplements: St. John's wort (SJW) and echinacea (above).
Our angry toxicologist points out that both supplements are bioactive - St John's wort is known to interfere with prescription drugs, for example. He (I'll assume it's a he but please correct me if I'm wrong, Prof Toxocologist) also talks about the comparative adverse responses of the herbal supplements in children and adults:
What interests me here is that the percentage of young people experiencing adverse effects was lower than the adults (For Echinacea: 3.4 vs 28.9%; For SJW 14.4 vs 46.4%). Possibilities: 1) Since children's exposures were largely accidental, they took very little compared to the intentional adult exposure. 2) Children who ingest any supplement are more likely to be reported whether they have symptoms or not while adults are more likely to reported only if they take too much or experience adverse effects. 3) Children are less sensitive to Echinacea and SJW (not likely base on current evidence).But the clear highlight is the mini-rant as he signs off:
So, I know it's legal and natural* but it's not safe; that goes double if you've got kids in the house. Oh, and shouldn't GNC et al. put their snake oil into child safe bottles? Not that they really care about anyone's health anyway, but it's nice to dream. *I don't consider it natural as it's extracted and processed. It's like saying digoxin is natural becuase of foxglove; or gasoline because of crude oil.Hear hear.
