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Expert Opinion on Drug Safety Dec 2021
Topics: Female; History, 20th Century; Humans; Immunosuppressive Agents; Pregnancy; Safety-Based Drug Withdrawals; Teratogens; Thalidomide
PubMed: 34623196
DOI: 10.1080/14740338.2021.1991307 -
Schmerz (Berlin, Germany) Dec 2014Metamizole (dipyrone) is a nonsteroidal compound with strong analgesic as well as antipyretic and spasmolytic properties. Based on a small number of cases of... (Comparative Study)
Comparative Study Review
Metamizole (dipyrone) is a nonsteroidal compound with strong analgesic as well as antipyretic and spasmolytic properties. Based on a small number of cases of agranulocytosis, metamizole was withdrawn from the market in some countries. Other countries restricted its use. This paper discusses the safety aspects of metamizole and compares it with other compounds used for similar indications.
Topics: Agranulocytosis; Anti-Inflammatory Agents, Non-Steroidal; Dipyrone; Drug Interactions; Humans; Risk; Safety-Based Drug Withdrawals
PubMed: 25199942
DOI: 10.1007/s00482-014-1490-7 -
Revue Medicale Suisse Jan 2021The main pharmacovigilance updates in 2020 are reviewed. Remdesivir in COVID-19: relatively safe but turns out to be less effective than expected. Hydroxychloroquine in... (Review)
Review
The main pharmacovigilance updates in 2020 are reviewed. Remdesivir in COVID-19: relatively safe but turns out to be less effective than expected. Hydroxychloroquine in COVID-19 : lack of efficacy and risk of arrhythmias. Cytokines storm in COVID-19: may impact pharmacokinetics. VEGF inhibitors: risk of aneurysm and artery dissection. Tofacitinib: dose-dependant risk of venous thromboembolic events. Ondansetron in the first trimester of pregnancy : a highly debated risk of orofacial cleft defects. Fingolimod : contraindicated during pregnancy due to suspected risk of congenital malformations. Ranitidine: global market withdrawal due to contamination with nitrosamines. Ulipristal for uterine fibroids : market withdrawal due to risk of severe liver injury. Ingenol mebutate : market withdrawal due to paradoxical risk of skin cancers.
Topics: Adenosine Monophosphate; Alanine; Cleft Lip; Contraindications, Drug; Cytokine Release Syndrome; Female; Fingolimod Hydrochloride; Humans; Hydroxychloroquine; Leiomyoma; Norpregnadienes; Pharmacokinetics; Pharmacovigilance; Pregnancy; Ranitidine; Safety-Based Drug Withdrawals; Skin Neoplasms; COVID-19 Drug Treatment
PubMed: 33443836
DOI: No ID Found -
Advances in Rheumatology (London,... Aug 2019Benzbromarone is a uricosuric drug that has been used in the treatment of gout over the last 30 years. Due to its potent inhibition of the dominant apical (luminal)... (Review)
Review
BACKGROUND
Benzbromarone is a uricosuric drug that has been used in the treatment of gout over the last 30 years. Due to its potent inhibition of the dominant apical (luminal) urate exchanger in the human proximal tubule URAT1, it reduces the urate reabsorption, diminishing serum urate levels and therefore preventing gout flares. Through several clinical trials, Benzbromarone has been proved effective and safe, inclusive in patients with chronic kidney disease and as combination therapy with allopurinol. Due to hepatotoxicity reports, it was withdrawn from the European market by the manufacturer, however many authors have questioned the product's withdrawal due to a lack of clinical evidence in order to support its hepatotoxicity. Benzbromarone is still available in several European countries, New Zealand, Brazil and several other countries. Despite the product's marketing over more than 20 years after the first hepatotoxicity reports, we have found only five reports in our literature search, and no prospective or retrospective study correlating hepatotoxicity with benzbromarone use.
SHORT CONCLUSION
Benzbromarone is a safe and effective molecule for the treatment of gout. However, due to in vitro and in vivo data related to hepatotoxicity, it is prudent to prescribe it with some caution, especially for patients with an already known liver condition.
Topics: Benzbromarone; Cytochrome P-450 CYP2C9; Gout; Humans; In Vitro Techniques; Liver; Mitochondria, Liver; Models, Animal; Organic Anion Transporters; Organic Cation Transport Proteins; Safety-Based Drug Withdrawals; Symptom Flare Up; Uricosuric Agents
PubMed: 31391099
DOI: 10.1186/s42358-019-0080-x -
Lakartidningen Dec 2018
Topics: Anticoagulants; Antithrombins; Atrial Fibrillation; Azetidines; Benzylamines; Dabigatran; Factor Xa Inhibitors; Humans; Safety-Based Drug Withdrawals; Stroke; Warfarin
PubMed: 30512138
DOI: No ID Found -
Orthopaedics & Traumatology, Surgery &... Feb 2016Patient safety requires speedy detection of any medical device malfunction; this is known as "materials vigilance". It entails the need to be able to trace back the... (Review)
Review
Patient safety requires speedy detection of any medical device malfunction; this is known as "materials vigilance". It entails the need to be able to trace back the life-long pathway of a device; this is "traceability". European regulations enact free circulation of medical devices throughout the European Union, with each member state being responsible for safety within its own territory. Medical devices are divided into 3 categories of increasing risk. CE marking mandatory for medical devices distributed within the EU, and count as market authorizations. They are delivered with 5-year validity by what is known as a "notified body". Health authorities are responsible for monitoring the market and any incidents. New regulations are presently being drawn up to improve efficiency and transparency. Materials vigilance is founded on mandatory declaration of medical device incidents. At local level, it comprises local reporters responsible for informing the National Health Products Safety Agency (Agence nationale de sécurité du médicament et des produits de santé [ANSM]) of any incidents and taking all necessary precautions. At national level, the ANSM assesses the safety, efficacy and quality of healthcare products; it centralizes and assesses materials vigilance reports and takes the requisite decisions. Materials vigilance is further organized at the European and international levels, to harmonize legislation regarding medical devices. Traceability is intended to rapidly identify medical device bearers in case of product recall. Each center is to organize the traceability of its devices; manufacturers' obligation of traceability ceases with the healthcare establishment or user. CE marking involves strict labeling rules to ensure safety of use. A change in the organization of traceability is presently underway, in the form of international Unique Device Identifiers, with harmonized label data, barcodes and standardized terminology. A European and later international database will be set up. The objective is to make Unique Device Identifiers mandatory within the EU by 2017.
Topics: Equipment Failure; Equipment and Supplies; European Union; Humans; Patient Safety; Product Labeling; Prostheses and Implants; Reference Standards
PubMed: 26822532
DOI: 10.1016/j.otsr.2015.05.013 -
Medecine Et Maladies Infectieuses Jun 2017Already used in various countries, trimethoprim (TMP) was withdrawn from the French market in 1990, but should be soon available again. This article reviews the... (Review)
Review
Already used in various countries, trimethoprim (TMP) was withdrawn from the French market in 1990, but should be soon available again. This article reviews the experience of TMP use around the world and its current use in Europe. Label use and guidelines only recommend the use of TMP for the treatment of urinary tract infections (UTI). Compared with co-trimoxazole (Co-T), a combination of TMP and sulfamethoxazole (SMX), TMP has (a) a similar resistance rate among Escherichia coli strains (estimated between 10 and 20% in uncomplicated cystitis), (b) a similar clinical efficacy for cystitis prevention and treatment, (c) a lower toxicity (as severe toxicity adverse effects of Co-T come from its sulfonamide component), (d) limited data for the treatment of pyelonephritis and male UTIs, and (e) an important impact on the microbiota. TMP should thus be indicated in the third-line empirical treatment of acute uncomplicated cystitis (sparing fluoroquinolones and nitrofurantoin), in the prevention of recurrent acute cystitis when an antibiotic prophylaxis is required (possibly in first line), and in the treatment of documented acute cystitis at risk of complications. Updated data on the epidemiology of resistance to TMP per clinical pictures is now required. The bactericidal effect of TMP should also be confirmed on recent strains (although limited recent data suggests a bactericidia similar to that of Co-T) and its clinical efficacy should be evaluated in pyelonephritis and male UTI.
Topics: Anti-Bacterial Agents; Cystitis; Drug Resistance, Bacterial; Drug Utilization; Escherichia coli; Escherichia coli Infections; Fosfomycin; France; Humans; Practice Guidelines as Topic; Product Recalls and Withdrawals; Trimethoprim; Trimethoprim, Sulfamethoxazole Drug Combination; Urinary Tract Infections
PubMed: 28043762
DOI: 10.1016/j.medmal.2016.12.001 -
Journal of Pharmacokinetics and... Apr 2021
Topics: Dose-Response Relationship, Drug; Drug Approval; Drug Recalls; Electrocardiography; Humans; Long QT Syndrome; Models, Biological; Software; Terfenadine
PubMed: 33826074
DOI: 10.1007/s10928-021-09754-z -
Journal Francais D'ophtalmologie Oct 2020
Topics: Adult; Biomedical Research; Blindness; Device Approval; France; Fund Raising; Germany; Humans; Implants, Experimental; Product Recalls and Withdrawals; Prosthesis Failure; Prosthesis Implantation; Retina; Retinal Diseases; Societies, Medical; United States; Visual Prosthesis
PubMed: 32622631
DOI: 10.1016/j.jfo.2020.06.003 -
Revista de Neurologia Apr 2018Daclizumab is a monoclonal antibody directed against the CD25 subunit of the interleukin-2 receptor, investigated as a disease-modifying therapy in relapsing-remitting... (Review)
Review
INTRODUCTION
Daclizumab is a monoclonal antibody directed against the CD25 subunit of the interleukin-2 receptor, investigated as a disease-modifying therapy in relapsing-remitting multiple sclerosis. The present review addresses how the drug was developed, the known mechanism of action of the drug and the up-to-date data of efficacy and safety.
DEVELOPMENT
Daclizumab has shown superiority in prevention of relapses against placebo and low-dose interferon beta-1a at a level that puts it on par with the rest of current first-line drugs. The effect on the progression of the disease and on neurodegeneration parameters, however, is not clear. On the other hand, it presents safety problems (mainly risk of autoimmunity phenomena including fulminant hepatopathy and encephalitis) that have supposed eventually its withdrawn from marketing. Daclizumab introduces a new mechanism of action through the blocking of a key interleukin in immune regulation and its effect on a population of cells with regulatory ability, such as the NK CD56(bright) cells.
CONCLUSIONS
Daclizumab has shown efficacy in slowing the inflammatory process of multiple sclerosis, although the appearance of potentially serious side effects has not allowed its use to significantly impact current clinical practice. The development of new drugs in multiple sclerosis must be contingent on maintaining or improving the risk-benefit profile with respect to those already in use.
Topics: Abnormalities, Drug-Induced; Antibodies, Monoclonal, Humanized; Autoimmune Diseases; Chemical and Drug Induced Liver Injury; Clinical Trials as Topic; Daclizumab; Drug Eruptions; Encephalitis; Female; Humans; Immunosuppressive Agents; Interferon beta-1a; Interleukin-2; Interleukin-2 Receptor alpha Subunit; Killer Cells, Natural; Models, Immunological; Multicenter Studies as Topic; Multiple Sclerosis; Pregnancy; Pregnancy Complications; Safety-Based Drug Withdrawals; T-Lymphocyte Subsets
PubMed: 29645071
DOI: No ID Found