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1.  Pharmacovigilance of herbal medicines: Current state and future directions 
Pharmacognosy Magazine  2011;7(25):69-73.
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.
PMCID: PMC3065161  PMID: 21472083
Guidelines; herbal medicines; pharmacovigilance; regulatory
2.  Consumers of natural health products: natural-born pharmacovigilantes? 
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.
PMCID: PMC2847952  PMID: 20184759
3.  Herbal products in Canada. How safe are they? 
Canadian Family Physician  1997;43:697-702.
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.
PMCID: PMC2255469  PMID: 9111986
4.  Underestimating the Toxicological Challenges Associated with the Use of Herbal Medicinal Products in Developing Countries 
BioMed Research International  2013;2013:804086.
Various reports suggest a high contemporaneous prevalence of herb-drug use in both developed and developing countries. The World Health Organisation indicates that 80% of the Asian and African populations rely on traditional medicine as the primary method for their health care needs. Since time immemorial and despite the beneficial and traditional roles of herbs in different communities, the toxicity and herb-drug interactions that emanate from this practice have led to severe adverse effects and fatalities. As a result of the perception that herbal medicinal products have low risk, consumers usually disregard any association between their use and any adverse reactions hence leading to underreporting of adverse reactions. This is particularly common in developing countries and has led to a paucity of scientific data regarding the toxicity and interactions of locally used traditional herbal medicine. Other factors like general lack of compositional and toxicological information of herbs and poor quality of adverse reaction case reports present hurdles which are highly underestimated by the population in the developing world. This review paper addresses these toxicological challenges and calls for natural health product regulations as well as for protocols and guidance documents on safety and toxicity testing of herbal medicinal products.
PMCID: PMC3791562  PMID: 24163821
5.  A Systematic Review of the Reporting of Adverse Events Associated with Medical Herb Use among Children 
To perform a systematic review of adverse events associated with herb use in the pediatric population. Since many health care providers get their information about the safety of herbal medicine from case reports published in the medical literature, it is important to assess the quality of these case reports.
Electronic literature search included 7 databases and a manual search of retrieved articles from inception through 2010. We included case reports and case series that reported an adverse event associated with exposure to an herbal product by children under the age of 18 years old. Based on the International Society of Epidemiology's “Guidelines for Submitting Adverse Events Reports for Publication”, we assigned a guideline adherence score (0-17) to each case report.
Ninety-six unique journal papers were identified and represented 128 cases. Of the 128 cases, 37% occurred in children under 2 years old, 38% between the ages of 2 – 8 years old, and 23 % between the ages 9-18 years old. In a few cases, the child used a product that was contaminated (5%) or adulterated (2%). Twenty-nine percent of cases were the result of an intentional ingestion while 36% were from an unintentional ingestion. Mean guideline adherence score was 12.5 (range 6 – 17).
There is considerable need for improvement in reporting adverse events in children following herb use. Without better quality reporting, adverse event reports cannot be interpreted reliably, and do not contribute in a meaningful way to guiding clinical recommendations.
PMCID: PMC3891367  PMID: 19203654
herbs; adverse events; pediatric; systematic review
6.  Buyer beware? Does the information provided with herbal products available over the counter enable safe use? 
BMC Medicine  2011;9:94.
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.
PMCID: PMC3180693  PMID: 21827684
7.  A Systematic Review of the Reporting of Adverse Events Associated With Medical Herb Use Among Children 
Information about the safety of herbal medicine often comes from case reports published in the medical literature, thus necessitating good quality reporting of these adverse events. The purpose of this study was to perform a systematic review of the comprehensiveness of reporting of published case reports of adverse events associated with herb use in the pediatric population.
Electronic literature search included 7 databases and a manual search of retrieved articles from inception through 2010. We included published case reports and case series that reported an adverse event associated with exposure to an herbal product by children under the age of 18 years old. We used descriptive statistics. Based on the International Society of Epidemiology's “Guidelines for Submitting Adverse Events Reports for Publication,” we developed and assigned a guideline adherence score (0-17) to each case report.
Ninety-six unique journal papers were identified and represented 128 cases. Of the 128 cases, 37% occurred in children under 2 years old, 38% between the ages of 2 and 8 years old, and 23% between the ages of 9 and 18 years old. Twenty-nine percent of cases were the result of an intentional ingestion while 36% were from an unintentional ingestion. Fifty-two percent of cases documented the Latin binomial of the herb ingredients; 41% documented plant part. Thirty-two percent of the cases reported laboratory testing of the herb, 20% documented the manufacturer of the product, and 22% percent included an assessment of the potential concomitant therapies that could have been influential in the adverse events. Mean guideline adherence score was 12.5 (range 6-17).
There is considerable need for improvement in reporting adverse events in children following herb use. Without better quality reporting, adverse event reports cannot be interpreted reliably and do not contribute in a meaningful way to guiding recommendations for medicinal herb use.
PMCID: PMC3833530  PMID: 24416663
Herbs; adverse events; pediatric; systematic review
8.  Herbal medicine: women's views, knowledge and interaction with doctors: a qualitative study 
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.
PMCID: PMC1702550  PMID: 17156416
9.  Interactions between Natural Health Products and Oral Anticoagulants: Spontaneous Reports in the Italian Surveillance System of Natural Health Products 
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.
PMCID: PMC3025393  PMID: 21274401
10.  Impact of Federal Safety Advisories on Health Food Store Advice 
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.
PMCID: PMC1492162  PMID: 15009783
anxiety; health food stores; kava
11.  Immunomodulation of Autoimmune Arthritis by Herbal CAM 
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.
PMCID: PMC3014691  PMID: 21234398
12.  Beyond the black box: drug- and device-associated hypersensitivity events 
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.
PMCID: PMC3108706  PMID: 21701613
adverse events; hypersensivity; toxicity; drug
13.  Pharmacy Student Perceptions of Adverse Event Reporting 
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.
PMCID: PMC3175663  PMID: 21969717
adverse event; adverse drug reaction; pharmacists; pharmacy students; adverse event reporting; FDA; HIPAA
14.  The growing use of herbal medicines: issues relating to adverse reactions and challenges in monitoring safety 
The use of herbal medicinal products and supplements has increased tremendously over the past three decades with not less than 80% of people worldwide relying on them for some part of primary healthcare. Although therapies involving these agents have shown promising potential with the efficacy of a good number of herbal products clearly established, many of them remain untested and their use are either poorly monitored or not even monitored at all. The consequence of this is an inadequate knowledge of their mode of action, potential adverse reactions, contraindications, and interactions with existing orthodox pharmaceuticals and functional foods to promote both safe and rational use of these agents. Since safety continues to be a major issue with the use of herbal remedies, it becomes imperative, therefore, that relevant regulatory authorities put in place appropriate measures to protect public health by ensuring that all herbal medicines are safe and of suitable quality. This review discusses toxicity-related issues and major safety concerns arising from the use of herbal medicinal products and also highlights some important challenges associated with effective monitoring of their safety.
PMCID: PMC3887317  PMID: 24454289
herbal medicines; adverse reactions; monitoring safety; challenges; public health
15.  Sale of kava extract in some health food stores 
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.
PMCID: PMC264954  PMID: 14638649
16.  The role of natural health products (NHPs) in dietetic practice: results from a survey of Canadian dietitians 
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.
PMCID: PMC3703453  PMID: 23819488
Dietitians; Professional roles and responsibilities; Natural health products; Dietary supplements; Nutritional supplements; Functional foods; Nutraceuticals; Herbal preparations
17.  The Canadian Drug Adverse Reaction Reporting Program 
Canadian Medical Association Journal  1966;95(25):1307-1309.
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.
PMCID: PMC1935866  PMID: 5928529
18.  Underreporting of Hemorrhagic and Thrombotic Complications of Pharmaceuticals to the U.S. Food and Drug Administration: Empirical Findings for Warfarin, Clopidogrel, Ticlopidine, and Thalidomide from the Southern Network on Adverse Reactions (SONAR) 
The U.S. Food and Drug Administration's (FDA) Adverse Event Reporting System (AERS), familiarly known as “MedWatch,” is the nation's primary tool for postmarket pharmaceutical safety surveillance. This system relies on adverse events voluntarily reported by health care providers and consumers either directly to the FDA or to drug manufacturers, which are required to prepare and forward the information to the agency. Little is known about how frequently adverse events are reported. Previous estimates range from 1 to 31% depending on the event, drug, and time period. We used published incidence studies to calculate reporting rates for hemorrhage, emergency hospitalization, and venous thromboembolism (VTE) associated with four drugs. We estimated annual reporting rates of 1.07% for 33,171 emergency hospitalizations of patients older than 65 years associated with warfarin, 0.9% for 13,363 hospitalizations of clopidogrel and ticlopidine, and 1.02% for an estimated 67,200 hemorrhage cases associated with warfarin. We also estimated a 9-year reporting rate of 2.3% for VTE associated with thalidomide. The incidence of these hematologic adverse drug events is high and reporting rates are low, and near the lower boundary of the 1 to 15% range seen for other events.
PMCID: PMC3947536  PMID: 23086541
U.S. Food and Drug Administration; adverse drug events; hemorrhage; venous thromboembolism; warfarin; thalidomide; clopidogrel; ticlopidine
19.  Design and Implementation of Cell-PREVEN: A Real-Time Surveillance System for Adverse Events Using Cell Phones in Peru 
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 (
PMCID: PMC1560594  PMID: 16779025
20.  The impact of herbal remedies on adverse effects and quality of life in HIV-infected individuals on antiretroviral therapy 
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.
PMCID: PMC3424263  PMID: 21330740
quality of life; herbal therapies; adverse drug reactions; antiretrovirals
21.  Data Mining of the Public Version of the FDA Adverse Event Reporting System 
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.
PMCID: PMC3689877  PMID: 23794943
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.
22.  The Role of Vaginal Mesh Procedures in Pelvic Organ Prolapse Surgery in View of Complication Risk 
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.
PMCID: PMC3771437  PMID: 24069035
23.  Green tea extract: A potential cause of acute liver failure 
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.
PMCID: PMC3746392  PMID: 23964154
Green tea; Plant extract; Dietary supplements; Liver failure; Liver injury; Hepatotoxicity
24.  Rosiglitazone use and associated adverse event rates in Canada between 2004 and 2010 
BMC Research Notes  2013;6:82.
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.
PMCID: PMC3606324  PMID: 23497453
Rosiglitazone; Prescription data; Adverse events; Risk communication
25.  Impact of Chinese Herbal Medicine on American Society and Health Care System: Perspective and Concern 
Many Americans, not completely satisfied with traditional western medicine, have turned to alternative and complementary medicine which explains the increasing popularity of the herbal products and the Chinese herbal medicine. The lack of government regulations and the increasing advertisements by the manufactures have created an impression to the common public that the natural herbal remedies are inherently safer and cheaper than conventional medicine. The skyrocketing rise of healthcare cost and the adverse reaction and side effects incurred from the prescribed drugs have both reinforced such an impression. Herbs in the USA and in many European countries have been prepared as capsules, tablets, teas, lozenges, juice extracts, tincture, and ointments. Most of the herbs are administered as a single herb in the USA and Europe. However, the traditional Chinese herbal medicine contains multiple active ingredients from various herbs and is prepared as concoctions by simmering them for hours to produce pharma-therapeutic properties useful for the treatment of a particular disease. Those prepared concoctions are taken gingerly with specific treatment purposes. In the USA and some European counties, herbs are distributed and labeled as dietary supplements and are taken by many individuals for a long period of time creating some medical and dental complex problems among them, especially in terms of anesthesia-surgery complications. This paper provides insight into basic differences in how herbs are prepared before administration to the patients in China versus a single unprepared herb sold in the USA and Europe. Also addressed are the interdisciplinary issues with health professionals, the proper regulations for better quality control of imported herbs, and the proper warning on the labels of the herbs.
PMCID: PMC3955605  PMID: 24719641

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