Analysis of data on capecitabine-related adverse drug reactions from the Korean adverse event reporting system database.

Eur J Oncol Nurs. 2018 Jun;34:55-60

Authors: Park JY

Abstract
PURPOSE: The purpose of this study was to evaluate the adverse drug reactions (ADRs) and serious adverse events associated with capecitabine use in Korean patients by analyzing data from a comprehensive national database of adverse events.
METHOD: Data from all reports concerning capecitabine (Anatomical Therapeutic Chemical code: L01BC06) generated between January 2011 and December 2014 were collected from the Korean Adverse Event Reporting System database (KAERS).
RESULTS: A total of 676 reports and 1069 capecitabine-related ADRs were identified. Ninety-nine cases (14.6%) were classified as serious adverse events. The most commonly reported capecitabine-related ADRs involved gastrointestinal system disorders (324, 30.3%), including diarrhea, nausea, vomiting, and stomatitis, followed by skin and appendage reactions (220, 20.6%), which included symptoms such as skin discoloration/disorder/dryness, itching, and rash.
CONCLUSIONS: Patients need to be educated about the common ADRs associated with capecitabine intake in a clinical setting. Patient characteristics must be considered when determining the capecitabine dosage and risk of ADRs, and nursing intervention is critical for preventing exacerbation of these ADRs.

PMID: 29784139 [PubMed - indexed for MEDLINE]

A nursing intervention aimed at reducing symptom burden during chemotherapy (CHEMO-SUPPORT): A mixed-methods study of the patient experience.

Eur J Oncol Nurs. 2018 Jun;34:35-41

Authors: Coolbrandt A, Milisen K, Wildiers H, Aertgeerts B, van Achterberg T, Van der Elst E, Dierckx de Casterlé B

Abstract
PURPOSE: CHEMO-SUPPORT is a nursing intervention that supports cancer patients in dealing with chemotherapy-related symptoms at home. The aims of the current study were (1) to determine how patients had experienced the intervention, and (2) to identify and better understand the mechanisms underlying CHEMO-SUPPORT's effects, its essential elements and possible pitfalls.
METHODS: All 71 patients who had received the CHEMO-SUPPORT intervention completed a questionnaire, asking their opinion on the helpfulness, strengths, and weaknesses of the individual components of the intervention. Semi-structured interviews were also conducted with a purposeful selection of 9 of the 71 patients to get a deeper understanding of the patient experience.
RESULTS: Nurses' caring support, combined with competent care, gave patients a sense of reassurance and made them feel (better) able to deal with their symptoms. The importance patients ascribed to the intervention varied according to the individual symptom experience and coping mechanisms of the patients, and by their experience with regular care. Patients rated the informational brochure component of the intervention most helpful. It served as their 'companion', offering support and expert advice at home. Patients felt that a strength of the brochure was the support they received from the quotes of fellow patients.
CONCLUSIONS: The CHEMO-SUPPORT intervention made patients feel more reassured and empowered in dealing with symptoms at home. That the CHEMO-SUPPORT experience was influenced by personal and contextual factors highlights the importance of tailoring the intervention to each patient, as well as improving supportive and competent symptom-management support in daily oncology care.

PMID: 29784136 [PubMed - indexed for MEDLINE]

Comparison of an injectable toltrazuril-gleptoferron (Forceris®) and an oral toltrazuril (Baycox®) + injectable iron dextran for the control of experimentally induced piglet cystoisosporosis.

Parasit Vectors. 2018 03 27;11(1):206

Authors: Joachim A, Shrestha A, Freudenschuss B, Palmieri N, Hinney B, Karembe H, Sperling D

Abstract
BACKGROUND: Cystoisospora suis causes diarrhoeal disease and reduced weight gain in suckling piglets, and a toltrazuril-based oral suspension is available for treatment. Recently a combinatorial product with toltrazuril plus iron has been developed for parenteral application. In this study we compared the efficacy of the injectable product with the oral suspension against experimentally induced piglet cystoisosporosis.
METHODS: In a randomised controlled study, three groups of piglets (n = 10-13) were treated either with a fixed dose of 45 mg toltrazuril + 200 mg gleptoferron i.m. per piglet (Forceris®) on the second day of life (study day 2; SD 2) or with 20 mg toltrazuril/kg body weight as an oral suspension (Baycox® 5%) on SD 4 or left untreated (Control group). The Baycox® and the Control group received 200 mg of iron dextran/piglet on SD 2. All piglets were infected with 1000 sporulated C. suis oocysts on SD 3. Faecal samples were taken daily from SD 7 to SD 20 to determine faecal consistency, oocyst shedding and other diarrhoeal pathogens. Body weight was recorded on SD 1 and then weekly until SD 29. Animals were observed daily for general health and after treatment for possible adverse events.
RESULTS: In the Control group all animals shed oocysts for 3.1 days on average and all animals showed diarrhoea for an average of five days. Excretion peaked on SD 9 (max. 48,618 oocysts per gram of faeces). Treatment with Forceris® completely suppressed oocyst excretion. In the Baycox® group, low levels of excretion could be detected. Diarrhoea was reduced to single piglets in the treated groups. Body weight development was reduced in the Control group compared to the treated groups. Enteropathogenic bacteria (Escherichia coli, Clostridium perfringens) could be detected. All parameters related to oocyst excretion, faecal consistency and weight gain were significantly improved in the treated groups compared to the Control group without significant differences between the treated groups. Both products were safe to use.
CONCLUSIONS: Treatment with both the injectable (Forceris®) and the oral (Baycox®) formulation of toltrazuril in the prepatent period were safe and highly effective against experimental infection with C. suis in newborn piglets.

PMID: 29580269 [PubMed - indexed for MEDLINE]

Polypharmacy and adverse drug events among propensity score matched privately insured persons with and without spinal cord injury.

Spinal Cord. 2018 06;56(6):591-597

Authors: Hand BN, Krause JS, Simpson KN

Abstract
STUDY DESIGN: Retrospective quasi-experimental design.
OBJECTIVES: To compare the incidence of adverse drug events (ADEs) between persons with and without spinal cord injury (SCI), while controlling for all potential and available risk factors.
SETTING: A commercially available claims dataset consisting of ~170 million patient cases in the United States between 2012 and 2013.
METHODS: Participants (aged 18-64 years) included 2779 persons with polypharmacy and traumatic or non-traumatic SCI and 2779 propensity score-matched persons with polypharmacy without SCI. The cohorts were matched using demographic variables including number of concomitant prescriptions, comorbidities, hospital admissions, age, gender, and geographic region. Inpatient and outpatient claims records containing 395 distinct IDC-9 codes indicative of ADEs were extracted. Incidence and frequency of ADEs were compared between groups using logistic and Poisson regression, respectively.
RESULTS: Persons with SCI were significantly more likely to experience an ADE than matched controls (Odds Ratio = 1.45, p < 0.0001). Among persons with ADEs (n = 1552), individuals with SCI experienced fewer ADEs over time than matched controls (Incidence Rate Ratio = 0.91, p < 0.0001).
CONCLUSIONS: While persons with SCI and polypharmacy are at a greater risk for experiencing an ADE, their medical care after an ADE may be better managed than that of a matched control population. There may be a need for practice guidelines that facilitate proactive identification of persons with SCI at the highest risk of ADE. Steps may then be taken to mitigate risk, in contrast to current practice trends that appear to take a reactive approach after an ADE has occurred.

PMID: 29362505 [PubMed - indexed for MEDLINE]

Management of Statin Intolerance in 2018: Still More Questions Than Answers.

Am J Cardiovasc Drugs. 2018 Jun;18(3):157-173

Authors: Toth PP, Patti AM, Giglio RV, Nikolic D, Castellino G, Rizzo M, Banach M

Abstract
Statin therapy is generally well tolerated and very effective in the prevention and treatment of cardiovascular disease, regardless of cholesterol levels; however, it can be associated with various adverse events (myalgia, myopathy, rhabdomyolysis, and diabetes mellitus, among others). Patients frequently discontinue statin therapy without medical advice because of perceived side effects and consequently increase their risk for cardiovascular events. In patients with statin intolerance, it may be advisable to change the dose, switch to a different statin, or try an alternate-day regimen. If intolerance is associated with all statins-even at the lowest dose-non-statin drugs and certain nutraceuticals can be considered. This review focuses on the definition of statin intolerance and on the development of clinical and therapeutic strategies for its management, including emerging alternative therapies.

PMID: 29318532 [PubMed - indexed for MEDLINE]

15 new pubmed citations were retrieved for your search. Click on the search hyperlink below to display the complete search results:

("drug-induced" OR "drug-related") AND ("adverse events" OR "side effects" OR "side-effects")

These pubmed results were generated on 2018/09/25

PubMed comprises more than millions of citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include links to full-text content from PubMed Central and publisher web sites.

15 new pubmed citations were retrieved for your search. Click on the search hyperlink below to display the complete search results:

("drug-induced" OR "drug-related") AND ("adverse events" OR "side effects" OR "side-effects")

These pubmed results were generated on 2018/09/25

PubMed comprises more than millions of citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include links to full-text content from PubMed Central and publisher web sites.

[Rational hypoglycemic therapy - nephro-diabetologic view].

Pol Merkur Lekarski. 2018 Aug 29;45(266):81-88

Authors: Kosmalski M, Kurnatowska I

Abstract
Diabetes is a heterogenous group of diseases with chronic hyperglycemia, which is associated with the risk of many complications, including diabetic kidney disease. Micro- and macroangiopathy in hyperglycemic environment leads to organ failure, including end-stage renal disease, requiring dialysis or kidney transplantation. However, diabetes is not the only cause leading to kidney dysfunction in this patient population. A patient with diabetes should be monitored regularly for proteinuria and glomerular filtration rate and depending on advancement of kidney disease or suspicion other than diabetes cause of kidney damage, should also be covered by nephrological care. Appropriately selected hypoglycemic drugs and their doses, in combination with appropriate non-pharmacological treatment, in the patients with different stages of kidney disease, not only reduces the risk of drug-induced side effects but, above all, may slow the progression of kidney damage and reduce the risk of other complications in this group of patients. Recently, there have been many new groups of hypoglycemic agents that can be used in the treatment of patients with kidney disease. The aim of this study is to present the current possibilities of hypoglycemic therapy in patients with different stages of chronic kidney disease. In addition, the relationship between individual groups of hypoglycemic agents and the renal benefits and risk was analyzed.

PMID: 30240375 [PubMed - in process]

What is known about deferasirox chelation therapy in pediatric HSCT recipients: two case reports of metabolic acidosis.

Ther Clin Risk Manag. 2018;14:1649-1655

Authors: Fucile C, Mattioli F, Marini V, Gregori M, Sonzogni A, Martelli A, Maximova N

Abstract
To date, in pediatric field, various hematological malignancies are increasingly treated with allogeneic hematopoietic stem cell transplantation (allo-HSCT). Iron overload and systemic siderosis often occur in this particular cohort of patients and are associated with poor prognosis. We describe herein the case of two allo-HSCT patients, on treatment with deferasirox; they showed histopathological elements compatible with venoocclusive disease or vanishing bile duct syndrome in ductopenic evolution before deferasirox started. The first patient developed drug-induced liver damage with metabolic acidosis and the second one a liver impairment with Fanconi syndrome. After withdrawing deferasirox treatment, both patients showed improvement. Measurements of drug plasma concentrations were performed by HPLC assay. The reduction and consequent disappearance of symptoms after the suspension of deferasirox substantiate its role in inducing hepatic damage, probably enabling the diagnosis of drug-induced liver damage. But the difficulties in diagnosing drug-related toxicity must be underlined, especially in compromised subjects. For these reasons, in patients requiring iron-chelating therapy, close and careful drug therapeutic monitoring is strongly recommended.

PMID: 30237719 [PubMed]

Efficacy and adverse reactions of methotrexate in the treatment of ocular cicatricial pemphigoid: A case series study.

Medicine (Baltimore). 2018 Sep;97(38):e12338

Authors: Shi Y, Xie C, He Y, Liu H, Zhu B, Zhu J

Abstract
The application of methotrexate (MTX) in the treatment of autoimmune diseases has been gradually increasing, but reports of MTX treatment for advanced ocular cicatricial pemphigoid (OCP) are extremely rare. This study investigated the efficacy and adverse reactions of low-dose MTX in patients with OCP.This was a retrospective, noncontrolled, case series study. Eleven patients diagnosed with advanced OCP (4 cases in stage III and 7 cases in stage IV) were enrolled. Treatment by oral administration of MTX (7.5 ± 2.5 mg) alone was performed. Visual acuity of the patients, conjunctival inflammation, cicatrization, ocular surface keratinization, and toxic side effects of drugs were evaluated.All patients enrolled in this study were females aged 32 to 83 years. Patients were followed up for 4 to 33 months. Low-dose MTX improved visual acuity of 3 cases (6 eyes, 27.3%). Conjunctival inflammation of 5 patients (10 eyes) rested after treatment, and conjunctival inflammation of 3 cases (6 eyes, 27.3%) was decreased with an effective rate of 72.7%. Cicatrices of 8 cases (15 eyes) showed degeneration after treatment with an effective rate of 71.4% (15/21). Ocular surface keratinization receded in 4 cases with an effective rate of 66.7%. None of the patients discontinued the treatment due to severe toxic side effects. All patients tolerated mild drug-induced gastrointestinal reactions. Three patients terminated the treatment in advance after 4 to 6 months due to no improvement in the disease condition.Observation of clinical efficacy and safety findings demonstrated that low-dose MTX can be used to treat patients with advanced OCP.

PMID: 30235689 [PubMed - in process]

A Retrospective Analysis of the Safety Profile of Intravenous Immunoglobulin in 1176 Patients Receiving Home Infusion Therapy.

J Clin Neuromuscul Dis. 2018 Jun;19(4):181-195

Authors: Souayah N, Pahwa A, Burawski L, Opila T, Sander HW

Abstract
OBJECTIVES: This analysis assessed the safety of intravenous immunoglobulin (IVIg) in the treatment of patients with neuroimmunological and immunological disorders in a home-based setting.
METHODS: Adverse reactions (ARs) were assessed in a retrospective review of 1176 patients receiving 28,677 home-based IVIg infusions between 1996 and 2013.
RESULTS: Of 1176 patients, 648 (55.1%) experienced IVIg-related ARs; 536 (45.6%) were mild, 78 (6.6%) moderate, and 34 (2.9%) severe. Thirty-seven (3.1%) patients were hospitalized because of ARs; of these, headache was most common (51.4%). Mean number of ARs per patient increased from 1.4 (low dose) to 3.6 (high dose). Incidence of ARs increased from 41% in the first 5-year moving average in 2003 to 65% in 2008. The number of ARs correlated with the number of infusions (ρ = 0.24; P < 0.001) and the average IVIg dose (ρ = 0.10; P < 0.001).
CONCLUSIONS: Low- and high-dose IVIg were safe and well tolerated with a few serious ARs in patients with neuroimmunological and immunological disorders.

PMID: 29794573 [PubMed - indexed for MEDLINE]

Development and validation of a logic model for comprehensive medication management services.

Int J Pharm Pract. 2018 Jun;26(3):250-257

Authors: Sousa SRAE, Shoemaker SJ, do Nascimento MMG, Costa MS, Ramalho de Oliveira D

Abstract
OBJECTIVES: To develop and validate a theoretical logic model for comprehensive medication management (CMM) services.
METHODS: The components of a logic model were constructed after a literature review and interviews with 4 CMM professionals. To validate the logic model, a panel of 17 CMM experts participated in three online Delphi method rounds to achieve consensus on the model. The consensus between the experts on each component of the logic model was evaluated using the Content Validity Index and Inter-rater Agreement in each of the rounds.
KEY FINDINGS: A logic model for CMM services containing 51 items was constructed and validated. Both the items of each component of the model and the linkage between the main components were agreed upon among the experts.
CONCLUSIONS: A logic model for CMM services was developed and validated. It is an innovative tool that, if used as a theoretical framework for the implementation of CMM, can ensure greater reproducibility of CMM services in different scenarios of practice and levels of care.

PMID: 28795451 [PubMed - indexed for MEDLINE]

Current state of pharmacovigilance in the Arab and Eastern Mediterranean region: results of a 2015 survey.

Int J Pharm Pract. 2018 Jun;26(3):210-221

Authors: Qato DM

Abstract
OBJECTIVES: This study describes the current state of pharmacovigilance systems in Arab and Eastern Mediterranean countries.
METHODS: A descriptive cross-sectional study was conducted between May and September 2015. Data were gathered from a standardized online survey sent to pharmacovigilance leadership identified as the official national contact for the WHO Programme for International Drug Monitoring. In countries with no specified pharmacovigilance programme or leadership, Ministry of Health officers responsible for drug safety policies were invited to participate in the survey. The survey measured three domains of pharmacovigilance performance using indicators that were defined and assigned scores a priori: 10 structural, 10 process, and seven impact indicators. Total scores were assigned to each domain of indicators, and countries were compared depending on their total performance score.
KEY FINDINGS: Complete responses were received from 20 countries (of 24 total), representing an 83% response rate. Approximately 20% (n = 4) of respondents reported not having any pharmacovigilance programme in their country. In total, across the three primary pharmacovigilance performance domains, the mean score for the 20 countries in the survey was 28.9 [standard deviation(SD): 13.8] with a range from 4 to 48 (maximum possible score: 48). In the structural performance domain, which assessed the existence of key pharmacovigilance structures, systems and policies in each country, the mean score among respondents was 13.1 (SD: 5.7) and the scores ranged from 2 to 19 (maximum possible score: 19). In the process performance domain, which assessed the constellation of activities undertaken by pharmacovigilance programmes (including the collection, collation, analysis and evaluation of adverse drug event reports), the mean score among respondent countries was 9.1 (SD: 5.4) and the scores ranged from 0 to 17 (maximum possible score: 17). Finally, in the impact domain, which measured the scope of national efforts at promoting risk minimization and increasing awareness in use of potentially unsafe pharmaceutical products, the mean score was 6.8 (SD: 3.6) and scores ranged from 0 to 12 (maximum possible score: 12).
CONCLUSIONS: The findings suggest wide disparities in pharmacovigilance systems in the region, underscoring the need for a multistakeholder effort in bolstering programme development and the necessity to build collaboration regionally and internationally to enhance capacity, improve public and healthcare provider awareness and assist in the development of pharmacovigilance systems still in their nascent stage.

PMID: 28737220 [PubMed - indexed for MEDLINE]

The Prevalence and Nature of Medication Errors and Adverse Events Related to Preadmission Medications When Patients Are Admitted to an Orthopedic Inpatient Unit: An Observational Study.

Ann Pharmacother. 2018 Sep 20;:1060028018802472

Authors: Tran T, Taylor SE, Hardidge A, Mitri E, Aminian P, George J, Elliott RA

Abstract
BACKGROUND: Medication errors commonly occur when patients move from the community into hospital. Whereas medication reconciliation by pharmacists can detect errors, delays in undertaking this can increase the risk that patients receive incorrect admission medication regimens. Orthopedic patients are an at-risk group because they are often elderly and use multiple medications.
OBJECTIVE: To evaluate the prevalence and nature of medication errors when patients are admitted to an orthopedic unit where pharmacists routinely undertake postprescribing medication reconciliation.
METHODS: A 10-week retrospective observational study was conducted at a major metropolitan hospital in Australia. Medication records of orthopedic inpatients were evaluated to determine the number of prescribing and administration errors associated with patients' preadmission medications and the number of related adverse events that occurred within 72 hours of admission.
RESULTS: Preadmission, 198 patients were taking at least 1 regular medication, of whom 176 (88.9%) experienced at least 1 medication error. The median number of errors per patient was 6 (interquartile range 3-10). Unintended omission of a preadmission medication was the most common prescribing error (87.4%). There were 17 adverse events involving 24 medications in 16 (8.1%) patients that were potentially related to medication errors; 6 events were deemed moderate consequence (moderate injury or harm, increased length of stay, or cancelled/delayed treatment), and the remainder were minor. Conclusion and Relevance: Medication errors were common when orthopedic patients were admitted to hospital, despite postprescribing pharmacist medication reconciliation. Some of these errors led to patient harm. Interventions that ensure that medications are prescribed correctly at admission are required.

PMID: 30234367 [PubMed - as supplied by publisher]

Dolutegravir-Related Neurological Adverse Events: A Case Report of Successful Management with Therapeutic Drug Monitoring.

Curr Drug Saf. 2018;13(1):69-71

Authors: Parant F, Miailhes P, Brunel F, Gagnieu MC

Abstract
OBJECTIVE: Dolutegravir (DTG), a highly effective second-generation HIV integrase inhibitor with high genetic barrier to resistance, has shown excellent tolerability and safety profiles in clinical trials. However, some patients may experience neurological or psychiatric adverse effects leading to DTG discontinuation.
CASE REPORT: This report describes a case of 29-year-old woman who developed neurological adverse events after starting the DTG-based antiretroviral therapy. Serum DTG concentrations were supratherapeutic which has required a dosing interval adjustment. The findings of this case report suggest that Therapeutic Drug Monitoring might be useful in individuals expressing unusual DTG pharmacokinetics.

PMID: 29345598 [PubMed - indexed for MEDLINE]

Observational study of drug-drug interactions in oncological inpatients.

Farm Hosp. 2018 01 01;42(1):10-15

Authors: Díaz-Carrasco MS, Almanchel-Rivadeneyra M, Tomás-Luiz A, Pelegrín-Montesinos S, Ramírez-Roig C, Fernández-Ávila JJ

Abstract
OBJECTIVE: To determine the prevalence of potential clinically relevant drug- drug interactions in adult oncological inpatients, as well as to describe the most  frequent interactions. A standard database was used.
METHOD: An observational, transversal, and descriptive study including patients  admitted to the Oncology Service of a reference hospital. All prescriptions were  collected twice a week during a month. They were analysed using Lexicomp®  database, recording all interactions classified with a level of risk: C, D or X.
RESULTS: A total of 1 850 drug-drug interactions were detected in 218  treatments. The prevalence of treatments with at least one clinically relevant  interaction was 95%, being 94.5% for those at level C and 26.1% for levels D  and X. The drugs most commonly involved in the interactions detected were  opioid analgesics, antipsychotics (butyrophenones), benzodiazepines,  pyrazolones, glucocorticoids and heparins, whereas interactions with  antineoplastics were minimal, highlighting those related to paclitaxel and  between metamizole and various antineoplastics.
CONCLUSIONS: The prevalence of clinically relevant drug-drug interactions rate  was very high, highlighting the high risk percentage of them related to level of  risk X. Due to the frequency of onset and potential severity, highlighted the  concomitant use of central nervous system depressants drugs with risk of  respiratory depression, the risk of onset of anticholinergic symptoms when  combining morphine or haloperidol with butylscopolamine, ipratropium bromide  or dexchlorpheniramine and the multiple interactions involving metamizole.

PMID: 29306307 [PubMed - indexed for MEDLINE]

A Case of Inappropriate Self-Medication Compounded with Prescribing vis-à-vis Dispensing Errors and the Hazardous Consequence.

Curr Drug Saf. 2018;13(1):51-54

Authors: Roy SS, Roy A, Santra Dhali R, Bagchi C, Banerjee G, Tripathi SK

Abstract
INTRODUCTION: Self-medication behavior appears to be a commonplace; and when it is ignorant it may prove dangerous. On the other hand, dispensing errors and consequent adverse outcomes, though not too uncommon, are seldom reported. We report here a case of methotrexateinduced acute vesico-bullous eruptions in a patient of psoriasis who indulged in self-medication and was wrongfully dispensed higher doses of methotrexate.
CASE DESCRIPTION: A 50-year-old man was diagnosed with psoriasis two years back and advised tablet methotrexate 20 mg once weekly and folic acid supplementation. He experienced symptoms remission after 8 weeks of treatment and preferred to discontinue the medication. As the psoriatic lesions reappeared four weeks ago, he attended a retail pharmacy for refill of the two-year old prescription. He was obliged by the man in the counter who wrongfully dispensed the medicine and the patient consumed methotrexate 10 mg twice daily. On the 20th days, the patient experienced erythematous, vesico-bullous lesions spread all over the body including both limbs and scalp, with oral mucosal involvement without any history of fever, and with mildly deranged liver function, and presented to the dermatology OPD of a tertiary hospital. He was admitted and treated with injection glucocorticoid and leucovorin. He responded well and completely recovered in a week. A 'probable' causality was adjudged for this serious adverse event by both WHO-UMC scale and Naranjo's algorithm. The reaction was moderately severe (Hartwig's scale) and it was definitively preventable (modified Schumock-Thornton scale).
CONCLUSION: This case report highlights the hazard of uninformed Self-medication and irresponsible dispensing behavior resulting in serious drug-related injury.

PMID: 28933275 [PubMed - indexed for MEDLINE]

Case Report: Severe Hematological, Muscle and Liver Toxicity Caused by Drugs and Artichoke Infusion Interaction in an Elderly Polymedicated Patient.

Curr Drug Saf. 2018;13(1):44-50

Authors: Campos MG, Machado J, Costa ML, Lino S, Correia F, Maltez F

Abstract
BACKGROUND: Case report, in a patient with a history of diabetes and hypertension, treated with metformin, gliclazide, enalapril + hydrochlorothiazide, amlodipine, aspirin and diazepam, recently medicated for a gouty crisis with colchicine and clonixin without improvement. Believing it could help in the treatment of gouty crisis symptoms he took about 1.5 L of artichoke infusion (Cynara cardunculus). He felt better and did agriculture work but developed a distal muscle pain, severe anemia, standard biochemical liver cholestasis, increase of alkaline phosphatase and marked increase of inflammatory parameters (hyperleucocytosis) and enters in the emergency department at the hospital.
OBJECTIVE: Evaluation of the cause of complaints and laboratory abnormalities and the involvement of artichoke infusion.
RESULTS: The prominence of the inflammatory parameters was ruled out because of exhaustive autoimmune, infectious or para-neoplastic syndrome (blood cultures, serology, diagnostic imaging, bone marrow and bone biopsy, muscle biopsy and nerve, abdominal angiography) were carried out showing normal results. The evaluation pointed out that the concomitant intake of artichoke infusion may have been involved in the framework developed, since the drugs which were being administered to/by the patient have a metabolism mainly mediated by CYP450 3A4 and 2C9 that could be compromised when these isoenzymes are inhibited by phenolic and flavonoid compounds from plants. Colchicine was one of the last drugs took that have as side effects most of the symptoms felt by patient including diarrhea and anemia.
CONCLUSION: The spontaneous and complete recovery of the patient and the negativity of research looking for other causes, conduce to a strong possibility of the interaction between artichoke and the drugs in the clinical presentation of this case.

PMID: 28901251 [PubMed - indexed for MEDLINE]

Angiotensin-converting enzyme inhibitors, angiotensin II receptors antagonists, beta-blockers and ivabradine as supportive therapy in pulmonary hypertension: Drug safety and tolerability.

Eur J Intern Med. 2017 Oct;44:e24-e27

Authors: Correale M, Zicchino S, Monaco I, Di Biase M, Brunetti ND

PMID: 28701278 [PubMed - indexed for MEDLINE]

Antiretroviral Therapy Program in Ethiopia Benefits From Virology Treatment Monitoring.

Ethiop J Health Sci. 2017 02;27(Suppl 1):1-2

Authors: Barnabas G, Sibhatu MK, Berhane Y

PMID: 28465648 [PubMed - indexed for MEDLINE]