Currently, a majority of the adverse events related to the use of herbal products and herbal medicines that are reported are attributable either to poor product quality or to improper use. Inadequate regulatory measures, weak quality control systems, and largely uncontrolled distribution channels (including mail order and Internet sales) may have been contributing to the occurrence of such events. In order to expand the knowledge about genuine adverse reactions to herbal medicines, and to avoid wasting scarce resources for identifying and analyzing adverse events, events resulting from such situations will need to be reduced or eliminated. Member States of the World Health Organization (WHO) are therefore encouraged to strengthen national regulation, registration and quality assurance and control of herbal medicines. In addition, the national health authorities should give greater attention to consumer education and to qualified practice in the provision of herbal medicines.
Guidelines; herbal medicines; pharmacovigilance; regulatory
Natural health products (NHPs), such as herbal medicines and vitamins, are widely available over-the-counter and are often purchased by consumers without advice from a healthcare provider. This study examined how consumers respond when they believe they have experienced NHP-related adverse drug reactions (ADRs) in order to determine how to improve current safety monitoring strategies.
Qualitative semi-structured interviews were conducted with twelve consumers who had experienced a self-identified NHP-related ADR. Key emergent themes were identified and coded using content analysis techniques.
Consumers were generally not comfortable enough with their conventional health care providers to discuss their NHP-related ADRs. Consumers reported being more comfortable discussing NHP-related ADRs with personnel from health food stores, friends or family with whom they had developed trusted relationships. No one reported their suspected ADR to Health Canada and most did not know this was possible.
Consumers generally did not report their suspected NHP-related ADRs to healthcare providers or to Health Canada. Passive reporting systems for collecting information on NHP-related ADRs cannot be effective if consumers who experience NHP-related ADRs do not report their experiences. Healthcare providers, health food store personnel, manufacturers and other stakeholders also need to take responsibility for reporting ADRs in order to improve current pharmacovigilance of NHPs.
OBJECTIVE: To examine existing evidence and inform family physicians about issues concerning herbal product use in Canada. QUALITY OF EVIDENCE: The Canadian Food and Drug Act and findings of an Expert Advisory Committee on Herbs and Botanical Preparations were consulted to provide an overview of the issues regarding herbal product regulation in Canada. Case reports of herbal toxicity were identified to illustrate some of the hazards of herbal products, and references provided to guide health professional in searching the literature for clinical trials that evaluate these drugs' efficacy. MAIN FINDINGS: Herbal products not registered as drugs in Canada are sold as foods and are exempt from the drug review process that evaluates product efficacy and safety. This places the public at risk of unwanted effects from the use of herbal products that are adulterated with other substances and of forgoing effective conventional therapy. Moreover, consumers are exposed to a plethora of information portraying herbal products as harmless. Some progress has been made to address these concerns by facilitating the registration of herbal products as drugs. CONCLUSIONS: Most herbal products that were evaluated were unsafe or ineffective, or no information was available to evaluate their efficacy. Despite the perception that herbal products are innocuous, family physicians need to be aware that herbal therapy can be harmful in order to help their patients make informed choices.
Herbal products obtained over the counter are commonly used in Europe, North America and Australia. Although there is concern about a lack of information provided to consumers to allow the safe use of these products, there has been no published research to confirm these fears. In this study, we evaluated written information provided with commonly used herbal products in the UK in advance of a European Union Directive issued in April 2011 that tightened regulations for some herbal products, including requirements to provide safety information.
Five commonly used herbal products were purchased from pharmacies, health food shops and supermarkets: St John's wort, Asian ginseng, echinacea, garlic and ginkgo. Written information provided with the products (on the package or on a leaflet contained in the package) was evaluated for inclusion of each of the key safety messages included in the monographs of the US National Center for Complementary and Alternative Medicine. Specifically, we looked for information on precautions (such as Asian ginseng not being suitable for people with diabetes), interactions with conventional medicines (such as St John's wort with the contraceptive pill and warfarin) and side effects (such as ginkgo and allergic reactions).
Our analysis showed that, overall, 51 (75%) of 68 products contained none of the key safety messages. This included 4 of 12 St John's wort products, 12 of 12 ginkgo products, 6 of 7 Asian ginseng products, 20 of 21 garlic products and 9 of 13 echinacea products. The two products purchased that are registered under the new European Union regulations (for St John's wort) contained at least 85% of the safety messages.
Most of the herbal medicine products studied did not provide key safety information which consumers need for their safe use. The new European Union legislation should ensure that St John's wort and echinacea products will include the previously missing information in due course. The legislation does not apply to existing stock. Depending on therapeutic claims made by manufacturers, garlic, ginkgo and Asian ginseng products may not be covered by the legislation and can continue to be bought without the safety information. Also, consumers will still be able to buy products over the internet from locations outside European Union jurisdiction. Potential purchasers need to know, in both the short term and the long term, how to purchase herbal products which provide the information they need for the safe use of these products.
There is growing concern that serious interactions are occurring between prescribed/over the counter and herbal medicines and that there is a lack of disclosure of herbal use by patients to doctors. This study explores women's perspectives about the safety of herbal remedies, herb-drug interactions and communication with doctors about herbal medicines.
Qualitative, cross-sectional study, with purposive sampling which took place in Cheshire, UK. Eighteen in depth semi-structured interviews were conducted with female herbal medicine users aged 18 years and above.
The large majority did not inform their GPs of their use of herbal medicines. This was due to lack of physician enquiry, perception of importance and fear of a negative response. Several women were not aware that herbal remedies could interact with prescribed or over the counter medicines. Of the women who had experienced adverse effects none had reported them, believing them of low importance.
The women had little knowledge about herb-drug interactions and rarely disclosed use of herbal medicines to their doctor. Doctors' communication and openness regarding herbal medicines needs to improve and there should be increased access to accurate information on herbal medicines in the public and health care domain.
Introduction. The safety of vitamin K antagonists (VKA) use can be compromised by many popular herbal supplements taken by individuals. The literature reports that 30% of warfarin-treated patients self-medicates with herbs. Possible interactions represent an health risk. We aimed to identify all herbs-oral anticoagulants interactions collected in the Italian database of suspected adverse reactions to “natural health” products. Methods. The Italian database of spontaneous reports of suspected adverse reactions to natural products was analyzed to address herb-VKAs interactions. Results. From 2002 to 2009, we identified 12 reports with 7 cases of INR reduction in patients treated with warfarin (n = 3) and acenocoumarol (n = 4), and 5 cases of INR increase (all warfarin associated). It was reported 8 different herbal products as possibly interacting. Discussion. Our study confirms the risk of interactions, highlighting the difficulty to characterize them and their mechanisms and, finally, prevent their onset. The reported data underline the urgent need of healthcare providers being aware of the possible interaction between natural products and VKA, also because of the critical clinical conditions affecting patients. This is the first step to have the best approach to understand possible INR alterations linked to herb-VKA interaction and to rightly educate patients in treatment with VKA.
Rheumatoid arthritis (RA) is a debilitating autoimmune disease of global prevalence. The disease is characterized by synovial inflammation leading to cartilage and bone damage. Most of the conventional drugs used for the treatment of RA have severe adverse reactions and are quite expensive. Over the years, increasing proportion of patients with RA and other immune disorders are resorting to complementary and alternative medicine (CAM) for their health needs. Natural plant products comprise one of the most popular CAM for inflammatory and immune disorders. These herbal CAM belong to diverse traditional systems of medicine, including traditional Chinese medicine, Kampo, and Ayurvedic medicine. In this paper, we have outlined the major immunological pathways involved in the induction and regulation of autoimmune arthritis and described various herbal CAM that can effectively modulate these immune pathways. Most of the information about the mechanisms of action of herbal products in the experimental models of RA is relevant to arthritis patients as well. The study of immunological pathways coupled with the emerging application of genomics and proteomics in CAM research is likely to provide novel insights into the mechanisms of action of different CAM modalities.
In early 2002, the FDA and Health Canada issued federal advisories that people should discontinue taking the herbal antianxiolitic kava kava, until further information regarding safety and potential for liver damage were determined. We conducted a field study 2 months following the advisories in Toronto, Canada to determine whether kava kava continued to be recommended to consumers at retail health food stores. Eight participants asked employees at all stores what was recommended for anxiety and whether the products were safe. Twenty-two of 34 stores recommended kava kava, 9 of which mentioned safety concerns. Physicians should be aware that federal advisories may not affect sales of unsafe products.
anxiety; health food stores; kava
Objective. To assess US pharmacy students’ knowledge and perceptions of adverse event reporting.
Methods. To gauge pharmacy students' impressions of adverse event reporting, a 10-question survey instrument was administered that addressed student perceptions of the reporting procedures of the Food and Drug Administration (FDA) and pharmaceutical manufacturers, as well as student understanding of the Health Insurance Portability and Accountability Act (HIPAA) and its relationship to adverse event reporting.
Results. Two hundred twenty-eight pharmacy students responded to the survey. The majority of respondents believed that the FDA is more likely than a pharmaceutical company to take action regarding an adverse event. There were misconceptions relating to the way adverse event reports are handled and the influence of HIPAA regulations on reporting.
Conclusions. Communication between the FDA and pharmaceutical manufacturers regarding adverse event reports is not well understood by pharmacy students. Education about adverse event reporting should evolve so that by the time pharmacy students become practitioners, they are well acquainted with the relevance and importance of adverse event reporting.
adverse event; adverse drug reaction; pharmacists; pharmacy students; adverse event reporting; FDA; HIPAA
Drug- and device-associated hypersensitivity reactions are serious toxicities that can result in respiratory failure or acute cardiac ischemic events, or even severe hypersensitivity syndromes such as Stevens–Johnson syndrome. These toxicities are usually poorly described in the “black box” warnings section of the product labels.
Adverse event reports contained in databases maintained by the Project on Medical Research on Adverse Drug Events and Reports (Med-RADAR), product labels, safety advisories disseminated by pharmaceutical manufacturers, the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC) were reviewed.
Adverse event reports identified three health care workers who developed nevirapine-associated Stevens–Johnson syndrome following occupational exposure to HIV-infected blood or blood products; four persons with localized hypersensitivity and fatal cardiac events associated with rapamycin- or paclitaxel-coated coronary artery stent placements; and six persons with breast cancer who developed severe or fatal anaphylaxis after receiving adjuvant chemotherapy with Cremophor-EL containing paclitaxel. Safety advisories from the FDA, CDC, and the relevant pharmaceutical manufacturers were ambiguous in their description in “black box” warning sections of package inserts describing these serious and potentially fatal toxicities.
Improvements are needed in pharmacovigilance and subsequent dissemination of safety advisories for drug/device-associated hypersensitivity reactions.
adverse events; hypersensivity; toxicity; drug
IN JANUARY 2002, HEALTH CANADA ISSUED AN ADVISORY, followed by a ban in August 2002, on the sale of herbal kava. One month after the advisory, 22 (67%) of 33 health food stores approached were selling kava. Two months after the ban, 17 (57%) of 30 stores continued to sell kava. These findings demonstrate that health food stores may need to be better informed about the sale of restricted natural health products.
Registered dietitians (RDs) play a key role in disseminating information about nutrition and intervening in nutrition-related disorders in the Canadian context. Natural health products (NHPs) are increasingly associated with nutrition in patient and health professional discussions. For this study, NHPs were divided into three categories: nutritional supplements (NS); functional foods/nutraceuticals (FF/N); and herbal preparations (HP). The objective was to explore RDs’ perceptions about their professional roles and responsibilities with respect to three categories of natural health products (NHPs).
This research consisted of an on-line survey of registered dietitians (RDs) in Ontario.
Surveys were distributed electronically to all practicing RDs in Ontario by the College of Dietitians of Ontario. There were 558 survey respondents, a response rate of 20%.
The vast majority of RDs reported being consulted by clients about all product categories (98% for NS; 94% for FF/N; 91% for HP), with RDs receiving the most frequent questions about NS and the least frequent about HP. 74% of RDs believed that NS are included within the current scope of practice, compared to 59% for FF/N and 14% for HP. Even higher numbers believed that these products should be included: 97% for NS, 91% for FF/N and 47% for HP. RDs who report personally ingesting FF/N and HP were significantly more likely to report that these products should be in the dietetic scope of practice. In contrast, RDs who provide one-on-one counselling services or group-level counselling/workshops were significantly less likely to believe HP should be in the dietetic scope of practice.
Opinions of RDs indicated that NS and FF/N (and possibly HP) fall within, or should fall within, RDs’ scope of practice. Opportunity exists for RDs to undertake a professional role with respect to NHPs. Policy clarification regarding RD roles is needed.
Dietitians; Professional roles and responsibilities; Natural health products; Dietary supplements; Nutritional supplements; Functional foods; Nutraceuticals; Herbal preparations
The origins and objectives of the Food and Drug Directorate's Drug Adverse Reaction Reporting Program are reviewed. A brief report from (F&D 123), which has been made available to all physicians, provides the means whereby suspected reactions to drugs can be reported to the Directorate. Information contained in these reports is treated as confidential. Twelve Canadian teaching hospitals have entered into a contractual agreement with the Directorate in order to investigate and evaluate suspected drug reactions occurring in the hospital setting. Manufacturers are notified if a problem appears to be arising in connection with a product, and discussions are held before any regulatory action is taken. Also, under the New Drug Regulations of 1963, pharmaceutical manufacturers are required to notify the F.D.D. if any unexpected reactions occur in association with their products. The Food and Drug Directorate is giving considerable thought to the means by which the interest of the profession in this program may be stimulated.
Use of herbal remedies among HIV-infected individuals in Africa increased in the past decade, mainly due to traditional beliefs and at times inconsistent access to antiretroviral drugs. In Zimbabwe, accessibility and availability of antiretroviral drugs has increased in recent years; however, the use of herbal remedies remains high. This study was conducted to determine the impact of concomitant use of herbal remedies with antiretroviral drugs on adverse events and on quality of life.
A convenient sample of HIV positive patients at Parirenyatwa group of hospitals' Family Care Clinic (Harare, Zimbabwe) was enrolled. A questionnaire was used to collect data on the adverse event experiences of the patients using herbal remedies for their HIV, as well as the types of herbal remedy used. Quality of life index was measured using an HIV/AIDS targeted quality of life (HAT-QOL) tool developed by the World Health Organization.
Abdominal pain (odds ratio = 2.7, p-value = 0.01) and rash (odds ratio = 2.5, p-value = 0.02) had significant associations with using herbal remedies during antiretroviral therapy. Improved quality of life index was not significantly associated with herbal remedy use during antiretroviral therapy.
There is evidence to suggest that some traditional herbal remedies used in Zimbabwe may increase incidence of certain types of adverse events when used in combination with antiretroviral drugs. Use of herbal drugs in combination with antiretroviral therapy does not significantly improve quality of life index in comparison to antiretroviral drug use only.
quality of life; herbal therapies; adverse drug reactions; antiretrovirals
With more clinical trials involving evaluations of new drugs or vaccines, monitoring
for early detection of adverse events is essential. The
overall goal of this study was to develop an interactive-computer system
using cell phones for real-time collection and transmission of adverse
events related to metronidazole administration among female sex workers (FSW) in
Peru. We developed an application for cell phones in Spanish, called
Cell-PREVEN, based on a system from Voxiva Inc. We used
cell phones to enter data collected by interviewers from FSW in three
communities. Information was stored in an online database, where it could
be immediately accessed worldwide and exported over a secure Internet
connection. E-mail and text messages sent to mobile devices alerted
key personnel to selected symptoms. This pilot project has demonstrated
that it is feasible to develop a public-health-surveillance system
based on cell phones to collect data in real-time in Peru (http://www.prevenperu.org).
The use of herbal products has increased significantly in recent years. Because these products are not subject to regulation by the Food and Drug Administration and are often used without supervision by a healthcare provider, the indication for and consumption of these supplements is quite variable. Moreover, their use is generally regarded as safe and natural by the lay-public. Unfortunately, there has been an increase in the number of reported adverse events occurring with the use of herbal products. We present a case of acute impending liver failure in an adolescent male using a weight-loss product containing green tea extract. Our case adds to the growing concern surrounding the ingestion of green tea extract and serves to heighten healthcare provider awareness of a potential green tea extract hepatotoxicity. Despite the generally touted benefits of green tea as a whole, clinical concern regarding its use is emerging and has been linked to its concentration in multiple herbal supplements. Interestingly, the suspected harmful compounds are those previously proposed to be advantageous for weight-loss, cancer remedy, and anti-inflammatory purposes. Yet, we emphasize the need to be aware of not just green tea extract, but the importance of monitoring patient use of all dietary supplements and herbal products.
Green tea; Plant extract; Dietary supplements; Liver failure; Liver injury; Hepatotoxicity
The US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS, formerly AERS) is a database that contains information on adverse event and medication error reports submitted to the FDA. Besides those from manufacturers, reports can be submitted from health care professionals and the public. The original system was started in 1969, but since the last major revision in 1997, reporting has markedly increased. Data mining algorithms have been developed for the quantitative detection of signals from such a large database, where a signal means a statistical association between a drug and an adverse event or a drug-associated adverse event, including the proportional reporting ratio (PRR), the reporting odds ratio (ROR), the information component (IC), and the empirical Bayes geometric mean (EBGM). A survey of our previous reports suggested that the ROR provided the highest number of signals, and the EBGM the lowest. Additionally, an analysis of warfarin-, aspirin- and clopidogrel-associated adverse events suggested that all EBGM-based signals were included in the PRR-based signals, and also in the IC- or ROR-based ones, and that the PRR- and IC-based signals were in the ROR-based ones. In this article, the latest information on this area is summarized for future pharmacoepidemiological studies and/or pharmacovigilance analyses.
adverse event; Adverse Event Reporting System; FAERS; database; data mining; signal; signal detection; proportional reporting ratio; reporting odds ratio; information component; empirical Bayes geometric mean; pharmacoepidemiology; pharmacovigilance.
Synthetic transvaginal mesh has been employed in the treatment of pelvic organ prolapse for more than a decade. As the use of these devices increased during this period so did adverse event reporting. In 2008, the Food and Drug Administration (FDA) Public Health Notification informed physicians and patients of rising concerns with the use of synthetic transvaginal mesh. Shortly thereafter and in parallel to marked increases in adverse event reporting within the Manufacturer and User Device Experience (MAUDE), the FDA released a Safety Communication regarding urogynecologic surgical mesh use. Following this report and in the wake of increased medical industry product withdrawal, growing medicolegal concerns, patient safety, and clinical practice controversy, many gynecologists and pelvic reconstructive surgeons are left with limited long-term data, clinical guidance, and growing uncertainty regarding the role of synthetic transvaginal mesh use in pelvic organ prolapse. This paper reviews the reported complications of synthetic transvaginal mesh with an evidence-based approach as well as providing suggested guidance for the future role of its use amidst the controversy.
We examined the change in the use of rosiglitazone-containing products (RCPs) Canada-wide between 2004 and 2010 and whether the rates of adverse events in association with RCP therapy in Canadian patients changed in this period to better understand the real world use of RCP medications and as part of a regulatory commitment by GlaxoSmithKline to Health Canada to assess whether there was an impact of a risk communication on cardiac safety.
RCP utilization data were obtained from IMS Brogan’s longitudinal de-identified patient database (known as LRx) that tracks prescription activity using store-based data collection from pharmacies in all Canadian provinces. Adverse events (AEs), serious adverse events (SAEs) and cardiac AEs associated with RCP use in Canadian patients between April 2004 and December 2010 were identified from GlaxoSmithKline’s AE database and, using the LRx data, rates per 100,000 patients were estimated.
A total of 239,184 patients were identified as having received at least one RCP prescription between 2004 and 2010 from the LRx. After excluding those with inconsistent gender or age, only one RCP prescription at the pharmacy, a prescription from a pharmacy that had not consistently reported for the past six years or an unreasonably high number of prescriptions, 180,936 patients remained for the analysis. The number of reports identified from the AE database that occurred between April 2004 and December 2010 was 1,037. The average monthly rates of AEs, SAEs and cardiac AEs decreased by 57%, 43% and 4%, respectively, between the observed periods, April 2004-October 2007 and November 2007-December 2010.
The findings of this analysis demonstrate a significant decrease in RCP use in Canada following a meta-analysis publication suggesting harm, which has been maintained. It is not possible to disentangle whether the continuing decline can be attributed to the meta-analysis, the changes in prescribing guidelines, media attention or a combination of some or all of these factors.
Rosiglitazone; Prescription data; Adverse events; Risk communication
More than 15 million people in the United States consume herbal remedies or high-dose vitamins. The number of visits to providers of complementary and alternative medicine exceeds those to primary care physicians, for annual out-of-pocket costs of $30 billion. Use of herbal products forms the bulk of treatments, particularly by elderly persons who also consume multiple prescription medications for comorbid conditions, which increases the risk of adverse herb-drug-disease interactions. Despite the paucity of scientific evidence supporting the safety or efficacy of herbal products, their widespread promotion in the popular media and the unsubstantiated health care claims about their efficacy drive consumer demand. In this review, we highlight commonly used herbs and their interactions with cardiovascular drugs. We also discuss health-related issues of herbal products and suggest ways to improve their safety to better protect the public from untoward effects.
cardiovascular agents; complementary therapies; drug approval; herbal medicine; herb-drug interaction
In Africa, herbal medicines are often used as primary treatment for HIV/AIDS and for HIV-related problems. In general, traditional medicines are not well researched, and are poorly regulated. We review the evidence and safety concerns related to the use of two specific African herbals, which are currently recommended by the Ministry of Health in South Africa and member states for use in HIV: African Potato and Sutherlandia. We review the pharmacology, toxicology and pharmacokinetics of these herbal medicines. Despite the popularity of their use and the support of Ministries of Health and NGOs in some African countries, no clinical trials of efficacy exist, and low-level evidence of harm identifies the potential for drug interactions with antiretroviral drugs. Efforts should be made by mainstream health professionals to provide validated information to traditional healers and patients on the judicious use of herbal remedies. This may reduce harm through failed expectations, pharmacologic adverse events including possible drug/herb interactions and unnecessary added therapeutic costs. Efforts should also be directed at evaluating the possible benefits of natural products in HIV/AIDS treatment.
The Food and Drug Administration (FDA) has issued a warning on numerous herbal drugs, including many popular products at General Nutrition Centers (GNC), regarding unstudied hepatotoxicity. There have been recent reports of GNC products such as hydroxycut and herbalife, causing drug-induced hepatitis. Herbal medications are over-the-counter products and are not investigated thoroughly by the FDA. Given that the most common outpatient laboratory abnormality is elevated liver transaminases, a sign of hepatocellular toxicity; it is not surprising that some of these products end up causing hepatic dysfunction, especially when taken in large volume. There are numerous herbal supplements that are hepatotoxic, however, these medications have a much more significant effect in human immunodeficiency virus (HIV)/ acquired immune deficiency syndrome patients, which is secondary to depleted glutathione. We present a rare case of drug induced hepatitis secondary to herbal medications used to treat HIV and elucidate the role of glutathione depletion in immunocompromised patients.
Glutathione; Human immunodeficiency virus; Acquired immune deficiency syndrome; Immunocompromised; Drug induced hepatitis; Hepatotoxicity; N-acetylcysteine; Herbal Medications
Despite many studies confirming that the use of complementary and alternative medicine (CAM) by children is common, few have assessed related adverse events.
To conduct a national survey to identify the frequency and severity of adverse events associated with paediatric CAM use.
Survey questions were developed based on a review of relevant literature and consultation with content experts. In January 2006, the Canadian Paediatric Surveillance Program distributed the survey to all paediatricians and paediatric subspecialists in active practice in Canada.
Of the 2489 paediatricians who received the survey, 583 (23%) responded. Respondents reported that they asked patients about CAM use 38% of the time and that patients disclosed this information before being questioned only 22% of the time. Forty-two paediatricians (7%) reported seeing adverse events, most commonly involving natural health products, in the previous year. One hundred five paediatricians (18%) reported witnessing cases of delayed diagnosis or treatment (n=488) that they attributed to the use of CAM.
While serious adverse events associated with paediatric CAM appear to be rare, delays in diagnosis or treatment seem more common. Given the lack of paediatrician-patient discussion regarding CAM use, our findings may under-represent adverse events. A lack of reported adverse events should not be interpreted as a confirmation of safety. Active surveillance is required to accurately assess the incidence, nature and severity of paediatric CAM-related adverse events. Patient safety demands that paediatricians routinely inquire about the use of CAM.
Adverse effects; Complementary therapies; Health survey; Manipulation; Natural products; Paediatrics; Spinal
The use of herbal medicines has increased dramatically over the past few years. The United States alone noted a 380% increase in the consumption of these products. Although the common practice of taking over-the-counter herbal soups, herbal teas and other such prepacked preparations was not associated with adverse events at large, still, some herbs are known to cause problems, especially when large doses are taken. The American Society of Anaesthesiologist (ASA) has taken a conservative stance and recommended that it is prudent to stop these products at least 2–3 weeks prior to anaesthesia and surgery. This advice may be difficult to implement as most preoperative evaluations occur only a few days prior to surgery. Some of the Ayurvedic preparations have shown to improve the patient outcome when taken during the perioperative period. Hence, the conservative stance by ASA may not always benefit the patient. More scientific studies are needed to have more targeted recommendations. This article puts forward the facts that need to be addressed by researchers in the future.
Amla; curcumin; garlic; giloe; ginger; ginseng; guggul; therapeutic claims; tulsi
Adverse drug events (ADEs) remain a large problem in the United States, being the fourth leading cause of death, despite post market drug surveillance. Much post consumer drug surveillance relies on self-reported “spontaneous” patient data. Previous work has performed datamining over the FDA’s Adverse Event Reporting System (AERS) and other spontaneous reporting systems to identify drug interactions and drugs correlated with high rates of serious adverse events. However, safety problems have resulted from the lack of post marketing surveillance information about drugs, with underreporting rates of up to 98% within such systems1,2.
We explore the use of online health forums as a source of data to identify drugs for further FDA scrutiny. In this work we aggregate individuals’ opinions and review of drugs similar to crowd intelligence3. We use natural language processing to group drugs discussed in similar ways and are able to successfully identify drugs withdrawn from the market based on messages discussing them before their removal.