Correction to: A Comparative View of Reported Adverse Effects of Statins in Social Media, Regulatory Data, Drug Information Databases and Systematic Reviews
The article A Comparative View of Reported Adverse Effects of Statins in Social Media. (Source: Drug Safety)
Source: Drug Safety - January 15, 2021 Category: Drugs & Pharmacology Source Type: research

Correction to: DNA Barcoding and Pharmacovigilance of Herbal Medicines
The Conflicts of interest section, which previously read. (Source: Drug Safety)
Source: Drug Safety - January 2, 2021 Category: Drugs & Pharmacology Source Type: research

French Pharmacovigilance Public System and COVID-19 Pandemic
AbstractThe current COVID-19 pandemic is an exceptional health situation including for drug use. As there was no known effective drug for COVID-19 at the beginning of the pandemic, different candidates were proposed. In this short article, we present the French public pharmacovigilance activities during this health crisis. Although COVID-19 is a confounding factor per se, owing to its potential for multi-organ damage including the heart and kidney, the quality of the transmitted data in adverse drug reaction reports, the timeliness of feedback from clinicians, and the real-time pharmacological and medical analysis by the F...
Source: Drug Safety - December 28, 2020 Category: Drugs & Pharmacology Source Type: research

The DIANA Study: Continued Access to Darunavir/Ritonavir (DRV/r) and Long-Term Safety Follow-Up in HIV-1-Infected Pediatric Patients Aged 3 to & lt;  18 Years
This study provided continued access to DRV/r and assessed long-term safety in patients aged 3 to
Source: Drug Safety - December 24, 2020 Category: Drugs & Pharmacology Source Type: research

Dissemination of Direct Healthcare Professional Communications on Medication Errors for Medicinal Products in the EU: An Explorative Study on Relevant Factors
ConclusionsThe absolute number of ME DHPCs for CAPs is low and does not give rise to immediate concern. We identified potential risk factors for ME DHPCs that should be taken into account during approval procedures or line extensions. (Source: Drug Safety)
Source: Drug Safety - December 23, 2020 Category: Drugs & Pharmacology Source Type: research

A Systematic Review and Meta-Analysis Considering the Risk for Congenital Heart Defects of Antidepressant Classes and Individual Antidepressants
ConclusionsThe selective serotonin reuptake inhibitor and serotonin norepinephrine reuptake inhibitor classes of antidepressants pose a greater risk for causing congenital heart defects than the tricyclic antidepressants. However, this risk for individual antidepressants within each class varies, and information regarding some antidepressants is still lacking. (Source: Drug Safety)
Source: Drug Safety - December 22, 2020 Category: Drugs & Pharmacology Source Type: research

Global Safety Database Summary of COVID-19-Related Drug Utilization-Safety Surveillance: A Sponsor ’s Perspective
ConclusionsThis pharmacovigilance surveillance study provides a unique characterization of cases in which a broad range of pharmaceutical products was reported in relation to COVID-19. (Source: Drug Safety)
Source: Drug Safety - December 22, 2020 Category: Drugs & Pharmacology Source Type: research

PCSK9 Inhibitors and Neurocognitive Adverse Drug Reactions: Analysis of Individual Case Safety Reports from the Eudravigilance Database
ConclusionOur results demonstrated that 22.7% of all ICSRs reporting alirocumab or evolocumab as suspect drugs described the occurrence of neuropsychiatric ADRs. The ROR showed that evolocumab and alirocumab had a higher reporting probability of neurological ADRs compared with statins. Further data from real-life contexts are needed. (Source: Drug Safety)
Source: Drug Safety - December 22, 2020 Category: Drugs & Pharmacology Source Type: research

Developing Crowdsourced Training Data Sets for Pharmacovigilance Intelligent Automation
ConclusionsCrowdsourcing is an accurate and efficient method that can be used to develop training data sets in support of pharmacovigilance automation. More research is needed to better understand the breadth and depth of possible uses as well as strengths, limitations, and generalizability of results. (Source: Drug Safety)
Source: Drug Safety - December 22, 2020 Category: Drugs & Pharmacology Source Type: research

Safety of N -Acetylcysteine at High Doses in Chronic Respiratory Diseases: A Review
AbstractN-Acetylcysteine (NAC) is widely used in respiratory medicine, with a maximum licensed dose in chronic use of 600 mg/day; however, some clinical trials have studied the efficacy of NAC at higher doses. The aim of this review was to evaluate the adverse effects profile of NAC at higher than the standard dose in chronic respiratory diseases to establish a risk –benefit ratio in increasing the daily dose; therefore, studies using NAC at a dose of at least 600 mg/day were selected. Forty-one articles where NAC has been used at 600 mg and above, up to 3000 mg/day, and with a specific report on safety, were conside...
Source: Drug Safety - December 16, 2020 Category: Drugs & Pharmacology Source Type: research

Effective Pharmacovigilance System Development: EFPIA-IPVG Consensus Recommendations
AbstractPharmaceutical legislation provides a legal framework to ensure the safe and effective use of medicines. This framework requires national regulatory authorities (NRAs) to establish and maintain a pharmacovigilance system (PV system) stating and enforcing the regulatory commitments that key stakeholders, including marketing authorisation holders (MAHs), are required to fulfil. In recent years, national legislative bodies and NRAs across the world have issued a significant amount of legislation and guidance enforcing the obligation to perform pharmacovigilance activities. In countries where the NRA is a member of the...
Source: Drug Safety - December 8, 2020 Category: Drugs & Pharmacology Source Type: research

Evaluation of Opioid Overdose Reports in Patients Treated with Extended-Release Naltrexone: Postmarketing Data from 2006 to 2018
ConclusionsOver the 12-year period, the reporting rates of opioid overdose were similar during treatment with or after discontinuation of XR-NTX and
Source: Drug Safety - November 30, 2020 Category: Drugs & Pharmacology Source Type: research

Risk of Cancer in Association with Ranitidine and Nizatidine vs Other H2 Blockers: Analysis of the Japan Medical Data Center Claims Database 2005 –2018
ConclusionsWe found no evidence that ranitidine/nizatidine is associated with an increased risk of cancer, although further studies with more accurate measurement of exposure, inclusion of older people, and longer follow-up may be needed. (Source: Drug Safety)
Source: Drug Safety - November 27, 2020 Category: Drugs & Pharmacology Source Type: research

Sex Differences in Lopinavir Concentrations and Occurrence of Marked QTc Prolongation Episodes in Patients with COVID-19
(Source: Drug Safety)
Source: Drug Safety - November 27, 2020 Category: Drugs & Pharmacology Source Type: research

Frequency and Associated Costs of Anaphylaxis- and Hypersensitivity-Related Adverse Events for Intravenous Iron Products in the USA: An Analysis Using the US Food and Drug Administration Adverse Event Reporting System
ConclusionsReporting rates of hypersensitivity and anaphylaxis with intravenous iron preparations were highest with ferumoxytol and lowest with ferric carboxymaltose in the US FAERS database. Adverse event-related medical costs were highest for iron dextran and ferumoxytol, and lowest for ferric carboxymaltose. (Source: Drug Safety)
Source: Drug Safety - November 25, 2020 Category: Drugs & Pharmacology Source Type: research

How to Investigate a Serious Adverse Event Reported During a Clinical Trial for a COVID-19 Vaccine
(Source: Drug Safety)
Source: Drug Safety - November 21, 2020 Category: Drugs & Pharmacology Source Type: research

Changes in Erythropoiesis Stimulating Agent Use Under a Risk Evaluation and Mitigation Strategy (REMS) Program
ConclusionREMS program implementation and enforcement were not associated with significant changes in ESA initiation, adding to concerns over the degree to which certain REMS programs enhance patient safety. (Source: Drug Safety)
Source: Drug Safety - November 18, 2020 Category: Drugs & Pharmacology Source Type: research

Acknowledgement to Referees
(Source: Drug Safety)
Source: Drug Safety - November 18, 2020 Category: Drugs & Pharmacology Source Type: research

Efficacy and Safety of Bevacizumab Plus Oxaliplatin- or Irinotecan-Based Doublet Backbone Chemotherapy as the First-Line Treatment of Metastatic Colorectal Cancer: A Systematic Review and Meta-analysis
AbstractIntroduction and ObjectiveGuidelines recommend combined doublet backbone chemotherapy based on 5-fluorouracil and oxaliplatin (OX) or irinotecan (IR) as the first-line treatment options for metastatic colorectal cancer. However, it is still unknown which is better when combined with bevacizumab (BEV). This systematic review and meta-analysis were performed to compare BEV-IR with BEV-OX regimens in terms of efficacy and safety.MethodsWe searched studies from databases including MEDLINE, EMBASE, CENTRAL, and conference papers. The outcomes were overall response rate, overall survival, progression-free survival, and t...
Source: Drug Safety - November 12, 2020 Category: Drugs & Pharmacology Source Type: research

Real-World Data on Nonmedical Use of Tramadol from Patients Evaluated for Substance Abuse Treatment in the NAVIPPRO Addiction Severity Index —Multimedia Version (ASI-MV ® ) Network
ConclusionTramadol had a significantly lower rate of NMU than comparator opioids and was less likely to be diverted or used via higher-risk non-oral routes. These findings support previous evaluations by WHO and the United States Drug Enforcement Agency that concluded that tramadol has a low potential for abuse. (Source: Drug Safety)
Source: Drug Safety - November 11, 2020 Category: Drugs & Pharmacology Source Type: research

Consensus Guidelines: Best Practices for Detection, Assessment and Management of Suspected Acute Drug-Induced Liver Injury During Clinical Trials in Adults with Chronic Viral Hepatitis and Adults with Cirrhosis Secondary to Hepatitis B, C and Nonalcoholic Steatohepatitis
AbstractWith the widespread development of new drugs to treat chronic liver diseases (CLDs), including viral hepatitis and nonalcoholic steatohepatitis (NASH), more patients are entering trials with abnormal baseline liver tests and with advanced liver injury, including cirrhosis. The current regulatory guidelines addressing the monitoring, diagnosis, and management of suspected drug-induced liver injury (DILI) during clinical trials primarily address individuals entering with normal baseline liver tests. Using the same laboratory criteria cited as signals of potential DILI in studies involving patients with no underlying ...
Source: Drug Safety - November 3, 2020 Category: Drugs & Pharmacology Source Type: research

An Algorithm for Comprehensive Medication Management in Nursing Homes: Results of the AMBER Project
ConclusionsThe developed and consented algorithm can guide pharmacists in conducting medication management in a timely and effective manner. It might serve as a facilitator to improve collaboration and quality of medication in nursing home residents. (Source: Drug Safety)
Source: Drug Safety - October 31, 2020 Category: Drugs & Pharmacology Source Type: research

Proposals for Engaging Patients and Healthcare Professionals in Risk Minimisation from an Analysis of Stakeholder Input to the EU Valproate Assessment Using the Novel Analysing Stakeholder Safety Engagement Tool (ASSET)
ConclusionsNew implementation theory-based approaches are promising for enhancing the valuable dialogue between regulators, patients and HCPs and achieving patient safety.EU PAS Register number:EUPAS35947 (Source: Drug Safety)
Source: Drug Safety - October 30, 2020 Category: Drugs & Pharmacology Source Type: research

Patterns of Benzodiazepine Use and Excess Risk of All-Cause Mortality in the Elderly: A Nationwide Cohort Study
ConclusionsThese findings confirm the existence of an excess risk of mortality associated with benzodiazepine use and provide pattern- and age-specific estimates. Higher risks were observed for patients aged  
Source: Drug Safety - October 30, 2020 Category: Drugs & Pharmacology Source Type: research

Use of Hydrochlorothiazide and Risk of Melanoma and Nonmelanoma Skin Cancer
ConclusionsUse of hydrochlorothiazide was associated with an increased risk of cSCC and with evidence of a duration – and dose–response relationship. In contrast, no association was observed for BCC or melanoma. (Source: Drug Safety)
Source: Drug Safety - October 26, 2020 Category: Drugs & Pharmacology Source Type: research

Chances and Challenges of Registry-Based Pharmacovigilance in Multiple Sclerosis: Lessons Learnt from the  Implementation of the Multicenter REGIMS Registry
This article will outline the chances and challenges of registry-based adverse event reporting, using the example of the German immunotherapeutic registry REGIMS. REGIMS is an observational, clinical multicenter registry that aims to assess the incidence, type, and consequences of side effects of MS immunotherapies. Patients treated with an approved MS medication are recruited by their physicians during routine visits in hospitals, outpatient clinics, and MS-specialized practices. REGIMS incorporates an  electronic physician-based documentation in each center and a paper-based patient documentation, both at basel...
Source: Drug Safety - October 23, 2020 Category: Drugs & Pharmacology Source Type: research

Potential Safety Issues with Use of Sodium-Glucose Cotransporter 2 Inhibitors, Particularly in People with Type 2 Diabetes and Chronic Kidney Disease
This article aims to explore the potential safety issues associated with the use of SGLT2 inhibitors, with a particular focus on the safety of these drugs in people with type 2 diabetes and chronic kidney disease. We discuss strategies that clinicians can implement to minimise the risk of adverse effects including diabetic ketoacidosis and volume depletion. Risk mitigation strategies with respect to SGLT2 inhibitor-associated diabetic ketoacidosis are of particular importance during the current coronavirus disease 2019 (COVID-19) pandemic. (Source: Drug Safety)
Source: Drug Safety - October 23, 2020 Category: Drugs & Pharmacology Source Type: research

Patient-Reported Adverse Events of Radiopharmaceuticals: A Prospective Study of 1002 Patients
ConclusionAdverse reactions to diagnostic radiopharmaceuticals can occur, and the frequency reported by patients was found to be 2.8%, which is higher than reported in the existing literature. We hope that the results of this study increase awareness of these adverse reactions among patients and healthcare professionals. (Source: Drug Safety)
Source: Drug Safety - October 22, 2020 Category: Drugs & Pharmacology Source Type: research

Psychiatric Disorders and Hydroxychloroquine for Coronavirus Disease 2019 (COVID-19): A VigiBase Study
ConclusionsThis pharmacovigilance analysis suggests that COVID-19 patients exposed to hydroxychloroquine experienced serious psychiatric disorders, and, among these patients, some committed suicide. Further real-world studies are needed to quantify the psychiatric risk associated with hydroxychloroquine during the COVID-19 pandemic. (Source: Drug Safety)
Source: Drug Safety - October 19, 2020 Category: Drugs & Pharmacology Source Type: research

Adverse Drug Reaction Reporting Using a Mobile Device Application by Persons with Multiple Sclerosis: A Cluster Randomized Controlled Trial
This study aimed to determine whether the use of an App, compared to traditional use through e-mail, telephone, or the national website, increased suspected adverse drug reaction (ADR) reporting by persons with multiple sclerosis receiving a first-line disease-modifying drug.MethodsAn open multi-centric, cluster-randomized controlled trial was conducted (VigipSEP study). Clusters were centers allocated (1:1) to the use of the My eReport France® App (experimental arm), and traditional reporting (control arm). Persons with multiple sclerosis initiating or switching to a first-line disease-modifying drug between April 201...
Source: Drug Safety - October 13, 2020 Category: Drugs & Pharmacology Source Type: research

The Work of the Council for International Organizations of Medical Sciences (CIOMS) in Global Pharmacovigilance
(Source: Drug Safety)
Source: Drug Safety - October 9, 2020 Category: Drugs & Pharmacology Source Type: research

Liver Injury Associated with the Selective Progesterone Modulator Ulipristal
(Source: Drug Safety)
Source: Drug Safety - October 9, 2020 Category: Drugs & Pharmacology Source Type: research

Artificial Intelligence, Real-World Automation and the Safety of Medicines
AbstractDespite huge technological advances in the capabilities to capture, store, link and analyse data electronically, there has been some but limited impact on routine pharmacovigilance. We discuss emerging research in the use of artificial intelligence, machine learning and automation across the pharmacovigilance lifecycle including pre-licensure. Reasons are provided on why adoption is challenging and we also provide a perspective on changes needed to accelerate adoption, and thereby improve patient safety. Last, we make clear that while technologies could be superimposed on existing pharmacovigilance processes for in...
Source: Drug Safety - October 6, 2020 Category: Drugs & Pharmacology Source Type: research

Follow-up on the Use of Advanced Analytics for Clinical Quality Assurance: Bootstrap Resampling to Enhance Detection of Adverse Event Under-Reporting
(Source: Drug Safety)
Source: Drug Safety - October 3, 2020 Category: Drugs & Pharmacology Source Type: research

ADE Eval: An Evaluation of Text Processing Systems for Adverse Event Extraction from Drug Labels for Pharmacovigilance
ConclusionWhile NLP techniques do not perform at levels that would allow them to be used without intervention, it is now worthwhile exploring making NLP outputs available in human pharmacovigilance workflows. (Source: Drug Safety)
Source: Drug Safety - October 1, 2020 Category: Drugs & Pharmacology Source Type: research

A Comparative View of Reported Adverse Effects of Statins in Social Media, Regulatory Data, Drug Information Databases and Systematic Reviews
ConclusionsCombining the data from multiple sources, albeit challenging, may provide a broader safety profile of any medication. Systematically collected social media reports may be able to contribute information on the most pertinent adverse effects to patients. (Source: Drug Safety)
Source: Drug Safety - September 30, 2020 Category: Drugs & Pharmacology Source Type: research

Introduction or Discontinuation of Additional Risk Minimisation Measures During the Life Cycle of Medicines in Europe
ConclusionsWe found low probabilities of introduction and discontinuation of aRMMs (excluding DHPCs) during the product life cycle for medicines authorised between 2006 and 2017. The low rate of discontinuation may potentially be due to a lack of robust data on effectiveness of aRMMs. Further research is needed to get more insight into the dynamics of aRMMs during the medicine life cycle. (Source: Drug Safety)
Source: Drug Safety - September 29, 2020 Category: Drugs & Pharmacology Source Type: research

Assessing the Safety of COVID-19 Vaccines: A Primer
AbstractVaccines against COVID-19 are being developed at speeds not previously achieved. With this unprecedented effort comes challenges for post-marketing safety monitoring and challenges for vaccine safety communication. To deploy these new vaccines fast across diverse populations, it is vital that robust pharmacovigilance and active surveillance systems are in place. Not all countries have the capability or resources to undertake adequate surveillance and will rely on data from those who can. The tools exist to assess COVID-19 vaccines as they are deployed such as surveillance systems, administrative data and case defin...
Source: Drug Safety - September 29, 2020 Category: Drugs & Pharmacology Source Type: research

Patient Organizations ’ Barriers in Pharmacovigilance and Strategies to Stimulate Their Participation
ConclusionBoth study phases show congruent results regarding patients ’ involvement and the activities patient organizations perform to promote drug safety. Patient organizations progressively position themselves as stakeholders in PV, carrying out many activities that stimulate awareness and participation of their members in drug safety, but still face internal and external barriers that can hamper their involvement. (Source: Drug Safety)
Source: Drug Safety - September 27, 2020 Category: Drugs & Pharmacology Source Type: research

Sex Differences in Reported Adverse Drug Reactions to COVID-19 Drugs in a Global Database of Individual Case Safety Reports
ConclusionReview of a global database of suspected ADR reports revealed sex differences in the reporting patterns for drugs used in the treatment of COVID-19. Patterns of ADR sex differences need further elucidation. (Source: Drug Safety)
Source: Drug Safety - September 24, 2020 Category: Drugs & Pharmacology Source Type: research

Community Pharmacists ’ Views and Experiences with ADR Reporting for Complementary Medicines: A Qualitative Study in New Zealand
ConclusionsParticipants used their knowledge of CMs safety concerns to minimise risk of harms to consumers from CMs use, but most had a passive approach to identifying and reporting ADRs for CMs. There is substantial potential for pharmacists to adopt proactive strategies in pharmacovigilance for CMs, particularly in recognising and reporting ADRs, and empowering CMs users to do the same. (Source: Drug Safety)
Source: Drug Safety - September 24, 2020 Category: Drugs & Pharmacology Source Type: research

The Potential Teratogenicity Alert for Women Conceiving on Dolutegravir-Based Regimens: An Assessment of Risk Communication by an Urban HIV Clinic in Uganda and Choices made by Women
We describe the choices made by women, as well as determine the factors associated with women ’s choices to switch off dolutegravir.MethodsA clinic response plan was developed in the first week following the alert and clinic staff were trained on safety guidance. All women aged  
Source: Drug Safety - September 13, 2020 Category: Drugs & Pharmacology Source Type: research

Benefit-Risk Assessment of Vaccines. Part II: Proposal Towards Consolidated Standards of Reporting Quantitative Benefit-Risk Models Applied to Vaccines  (BRIVAC)
ConclusionsThe BRIVAC checklist is the first initiative providing an operational checklist for improved reporting of qBRm applied to vaccines in scientific articles. It is intended to assist authors, peer-reviewers, editors and readers in their critical appraisal. Future initiatives are needed to provide methodological guidance to perform qBRm while taking into account the vaccine specificities. (Source: Drug Safety)
Source: Drug Safety - September 11, 2020 Category: Drugs & Pharmacology Source Type: research

Benefit –Risk Assessment of Vaccines. Part I: A Systematic Review to Identify and Describe Studies About Quantitative Benefit–Risk Models Applied to Vaccines
ConclusionsThis review provides an extensive list of qBRm applied to vaccines. Discrepancies across studies were identified during our review. While the number of published qBRm studies is increasing, no reporting guidance for qBRm applied to vaccines is currently available. This may affect decision makers ’ confidence in the results and their benefit–risk assessment(s); therefore, the development of such reporting guidance is highly needed. (Source: Drug Safety)
Source: Drug Safety - September 9, 2020 Category: Drugs & Pharmacology Source Type: research

Post-Marketing Safety Surveillance for the Adjuvanted Recombinant Zoster Vaccine: Methodology
AbstractA diligent, systematic, regular review of aggregate safety data is essential, particularly early after vaccine introduction, as this is when safety signals not identified during clinical development may emerge. In October 2017, the US Centers for Disease Control and Prevention Advisory Committee on Immunization Practices recommended the adjuvanted recombinant zoster vaccine (RZV;Shingrix, GSK) as the preferred vaccine for preventing herpes zoster (HZ) and related complications in immunocompetent adults aged ≥ 50 years. Subsequently, GSK experienced an unprecedented high demand for RZV. In this methodology p...
Source: Drug Safety - August 29, 2020 Category: Drugs & Pharmacology Source Type: research

Current Evidence on Abuse and Misuse of Gabapentinoids
AbstractThis review summarizes current evidence on the abuse and misuse of the gabapentinoids pregabalin and gabapentin. Pharmacovigilance studies, register-based studies, surveys, clinical toxicology studies, and forensic toxicology studies were identified and scrutinized with the goal to define the problem, identify risk factors, and discuss possible methods to reduce the potential for abuse and misuse. Studies found that gabapentinoids are abused and misused and that individuals with a history of psychiatric disorders or substance use disorder seem to be at high risk. Moreover, some evidence supports the notion that pat...
Source: Drug Safety - August 27, 2020 Category: Drugs & Pharmacology Source Type: research

Renin –Angiotensin–Aldosterone System Inhibitors and Risk of Death in Patients Hospitalised with COVID-19: A Retrospective Italian Cohort Study of 43,000 Patients
ConclusionsACEI/ARB use is not associated with either an increased or decreased risk of all-cause mortality, compared with CCB use, in the largest cohort of hospitalised COVID-19 patients exposed to these drugs studied to date. The use of these drugs therefore does not affect the prognosis of COVID-19. This finding strengthens recommendations of international regulatory agencies about not withdrawing/switching ACEI/ARB treatments to modify COVID-19 prognosis. (Source: Drug Safety)
Source: Drug Safety - August 26, 2020 Category: Drugs & Pharmacology Source Type: research

Safety of the Geneva Cocktail, a Cytochrome P450 and P-Glycoprotein Phenotyping Cocktail, in Healthy Volunteers from Three Different Geographic Origins
ConclusionsIn this research, healthy volunteers from three different human populations were phenotyped with the Geneva cocktail. Four adverse events were observed, confirming the safety of this cocktail that is given at lower than clinically relevant doses and therefore results in concentrations lower than those reported to cause adverse events. (Source: Drug Safety)
Source: Drug Safety - August 25, 2020 Category: Drugs & Pharmacology Source Type: research

Direct Oral Anticoagulants and Interstitial Lung Disease: Emerging Clues from Pharmacovigilance
(Source: Drug Safety)
Source: Drug Safety - August 25, 2020 Category: Drugs & Pharmacology Source Type: research

Understanding and Responding to Prescribing Patterns of Sodium Valproate-Containing Medicines in Pregnant Women and Women of Childbearing Age in Western Cape, South Africa
AbstractIntroductionGrowing evidence of the teratogenic potential of sodium valproate (VPA) has changed prescribing practices across the globe; however, the impact of this research and the consequent dissemination of a Dear Health Care Professional Letter (DHCPL) in December 2015, recommending avoidance of the teratogen VPA in women of childbearing age (WOCBA) and pregnant women in South Africa, is unknown. We explored trends and reasons for VPA use among pregnant women and WOCBA in the public sector in Western Cape Province from 1 January 2015 to 31 December 2017.MethodsUsing the provincial health information exchange tha...
Source: Drug Safety - August 24, 2020 Category: Drugs & Pharmacology Source Type: research