Comparative Safety of Vaccine Adjuvants: A Summary of Current Evidence and Future Needs
Abstract Use of highly pure antigens to improve vaccine safety has led to reduced vaccine immunogenicity and efficacy. This has led to the need to use adjuvants to improve vaccine immunogenicity. The ideal adjuvant should maximize vaccine immunogenicity without compromising tolerability or safety. Unfortunately, adjuvant research has lagged behind other vaccine areas such as antigen discovery, with the consequence that only a very limited number of adjuvants based on aluminium salts, monophosphoryl lipid A and oil emulsions are currently approved for human use. Recent strategic initiatives to support adjuvant...
Source: Drug Safety - October 8, 2015 Category: Drugs & Pharmacology Source Type: research

Feasibility of Prioritizing Drug–Drug-Event Associations Found in Electronic Health Records
Abstract Background and Objective Several studies have demonstrated the ability to detect adverse events potentially related to multiple drug exposure via data mining. However, the number of putative associations produced by such computational approaches is typically large, making experimental validation difficult. We theorized that those potential associations for which there is evidence from multiple complementary sources are more likely to be true, and explored this idea using a published database of drug–drug-adverse event associations derived from electronic health records (EHRs). ...
Source: Drug Safety - October 8, 2015 Category: Drugs & Pharmacology Source Type: research

Statistical Signal Detection as a Routine Pharmacovigilance Practice: Effects of Periodicity and Resignalling Criteria on Quality and Workload
Conclusions In real-life PV practice, signal detection and validation are recurrent periodic activities. Some true signals are only discovered upon resignalling. Our results demonstrate resignalling criteria with high signal detection quality and high efficiency. We found potential earlier detection of true signals using monthly SSD. Additional studies about resignalling should be performed to complement our findings. (Source: Drug Safety)
Source: Drug Safety - September 21, 2015 Category: Drugs & Pharmacology Source Type: research

Association of Attorney Advertising and FDA Action with Prescription Claims: A Time Series Segmented Regression Analysis
Conclusion Regulatory and safety actions likely reduced the number of users and/or prescription rates for some drugs. Attorneys may have strategically chosen to begin advertising adverse drug events prior to major safety actions, but we found little evidence that attorney advertising reduced drug use. Further research is needed to better understand how consumers and physicians respond to attorney advertising. (Source: Drug Safety)
Source: Drug Safety - September 18, 2015 Category: Drugs & Pharmacology Source Type: research

Impact on Drug Safety of Variation in Adherence: The Need for Routinely Reporting Measures of Dose Intensity in Medication Safety Studies Using Electronic Health Data
Abstract Randomized controlled trials always report the dose assessed and usually include a measure of adherence. By comparison, observational studies assessing medication safety often fail to report the dose used and rarely report any measure of adherence to therapy. This limits the ability to control for differences in doses used when undertaking meta-analyses. Non-adherence with therapy is common in the practice setting and varies across countries and settings. Inter-country differences in the registration of medicines may also result in different product strengths being available in different countries. These ...
Source: Drug Safety - September 18, 2015 Category: Drugs & Pharmacology Source Type: research

15th ISoP Annual Meeting “Cubism in Pharmacovigilance” Prague, Czech Republic 27-30 October, 2015
(Source: Drug Safety)
Source: Drug Safety - September 15, 2015 Category: Drugs & Pharmacology Source Type: research

Drug-Induced Hyperglycaemia and Diabetes
Abstract Drug-induced hyperglycaemia and diabetes is a global issue. It may be a serious problem, as it increases the risk of microvascular and macrovascular complications, infections, metabolic coma and even death. Drugs may induce hyperglycaemia through a variety of mechanisms, including alterations in insulin secretion and sensitivity, direct cytotoxic effects on pancreatic cells and increases in glucose production. Antihypertensive drugs are not equally implicated in increasing serum glucose levels. Glycaemic adverse events occur more frequently with thiazide diuretics and with certain beta-blocking agents tha...
Source: Drug Safety - September 14, 2015 Category: Drugs & Pharmacology Source Type: research

Useful Interplay Between Spontaneous ADR Reports and Electronic Healthcare Records in Signal Detection
Conclusion An EHR-based system may have additional value for signal detection, alongside already established systems, especially in the presence of adverse events with a high background incidence. While the SRS appeared to be more cost effective overall, for some events the costs associated with signal detection in the EHR might be justifiable. (Source: Drug Safety)
Source: Drug Safety - September 14, 2015 Category: Drugs & Pharmacology Source Type: research

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): A National Analysis of Data from 10-Year Post-marketing Surveillance
Conclusion Thanks to the largest national DRESS case series ever reported, we were able to hypothesize, for the first time, that there is an association between use of drugs containing an aromatic ring in their chemical structure and DRESS. This might aid understanding of the aetiology of DRESS and facilitate diagnosis. (Source: Drug Safety)
Source: Drug Safety - September 14, 2015 Category: Drugs & Pharmacology Source Type: research

A Note on the Validity and Reliability of Multi-Criteria Decision Analysis for the Benefit–Risk Assessment of Medicines
Abstract The comparative evaluation of benefits and risks is one of the most important tasks during the development, market authorization and post-approval pharmacovigilance of medicinal products. Multi-criteria decision analysis (MCDA) has been recommended to support decision making in the benefit–risk assessment (BRA) of medicines. This paper identifies challenges associated with bias or variability that practitioners may encounter in this field and presents solutions to overcome them. The inclusion of overlapping or preference-complementary criteria, which are frequent violations to the assumptions of thi...
Source: Drug Safety - September 9, 2015 Category: Drugs & Pharmacology Source Type: research

Risk of Out-of-Hospital Sudden Cardiac Death in Users of Domperidone, Proton Pump Inhibitors, or Metoclopramide: A Population-Based Nested Case-Control Study
Conclusions Compared with non-use of any study drug, current domperidone use was associated with sudden cardiac death in nested case-control and case-crossover analyses, with a suggestion of higher risk in older persons and users of higher daily doses. (Source: Drug Safety)
Source: Drug Safety - September 8, 2015 Category: Drugs & Pharmacology Source Type: research

Signal for Thrombosis with Eltrombopag and Romiplostim: A Disproportionality Analysis of Spontaneous Reports Within VigiBase ®
Conclusion This study suggests the presence of a signal for an increased risk of thrombosis with eltrombopag compared with romiplostim. These results must be confirmed and quantified by large aetiological pharmacoepidemiological studies. (Source: Drug Safety)
Source: Drug Safety - September 4, 2015 Category: Drugs & Pharmacology Source Type: research

Future Proofing Adverse Event Monitoring
(Source: Drug Safety)
Source: Drug Safety - September 1, 2015 Category: Drugs & Pharmacology Source Type: research

Safety Profile of Certolizumab Pegol in Patients with Immune-Mediated Inflammatory Diseases: A Systematic Review and Meta-Analysis
Conclusion Safety data on CZP suggest an overall favorable tolerability profile, with infections being the most common AE. However, CZP-treated patients had a twofold higher risk of infectious SAEs than control patients. Large observational studies and data from national registries are needed to detect rare AEs, which might occur after long-term exposures to CZP. (Source: Drug Safety)
Source: Drug Safety - August 28, 2015 Category: Drugs & Pharmacology Source Type: research

Experiences and Lessons From Implementing Cohort Event Monitoring Programmes for Antimalarials in Four African Countries: Results of a Questionnaire-Based Survey
Conclusions The reported experiences of four NCs that have undertaken CEM studies on ACTs indicate that CEM has helped to build pharmacovigilance capacity within NCs and monitoring sites and that HCPs are willing to participate in CEM programmes; however, the method was found to be labour intensive and data management was identified as a challenge. Reducing the workload associated with CEM, particularly in relation to data management, and integrating the method into the routine work of HCPs and NCs should be considered for future implementation. (Source: Drug Safety)
Source: Drug Safety - August 13, 2015 Category: Drugs & Pharmacology Source Type: research

Modelling Hospitalisation Ratios for Febrile Convulsions and Severe Varicella Under Combined Measles, Mumps, Rubella, and Varicella (MMRV—Priorix-Tetra™) Compared to Separate MMR + V Vaccination
Conclusions MMRV use instead of MMR + V can substantially reduce the number of hospitalisation days, despite increased FC risk when MMRV is used as a first dose of measles-containing vaccine. (Source: Drug Safety)
Source: Drug Safety - August 7, 2015 Category: Drugs & Pharmacology Source Type: research

Safety of Perflutren Ultrasound Contrast Agents: A Disproportionality Analysis of the US FAERS Database
The objective of this study was to supplement existing knowledge of the reported safety of perflutren using statistical analysis of spontaneous reports. Methods We analyzed information from the US Food and Drug Administration Adverse Event Reporting System using a disproportionality analysis. Analysis of overall reporting for perflutren was supplemented by subset (age, indication) analysis. A signal of disproportionate reporting (SDR) was defined as EB05>2. Results Overall, 18/380 Preferred Terms and 1/83 Standardized Medical Queries had SDR...
Source: Drug Safety - August 5, 2015 Category: Drugs & Pharmacology Source Type: research

Evaluating Social Media Networks in Medicines Safety Surveillance: Two Case Studies
Conclusions Publicly available data from the considered social media networks were sparse and largely untrackable for the purpose of providing early clues of safety concerns regarding the prespecified case studies. Further research investigating other case studies and exploring other social media platforms are necessary to further characterise the usefulness of social media for safety surveillance. (Source: Drug Safety)
Source: Drug Safety - August 5, 2015 Category: Drugs & Pharmacology Source Type: research

Authors’ Reply to Cotton and Nicol’s Comment on “Adverse Drug Reactions and Clinical Outcomes in Patients Initiated on Antiretroviral Therapy: A Prospective Cohort Study from Ethiopia”
(Source: Drug Safety)
Source: Drug Safety - August 5, 2015 Category: Drugs & Pharmacology Source Type: research

Comment on: “Adverse Drug Reactions and Clinical Outcomes in Patients Initiated on Antiretroviral Therapy: A Prospective Cohort Study from Ethiopia”
(Source: Drug Safety)
Source: Drug Safety - August 5, 2015 Category: Drugs & Pharmacology Source Type: research

Vaccine–Drug Interactions: Cytokines, Cytochromes, and Molecular Mechanisms
Abstract Vaccinations are recommended throughout life to reduce the risk of vaccine-preventable diseases and their sequelae. Vaccines are often administered in patients with chronic diseases who are likely to be treated with several drugs. A growing number of clinical observations have indicated the possibility of interactions between vaccines and drugs, leading to changes in drug metabolism after vaccination. These interactions represent a significant concern because of the increasing use of vaccines in older patients who are likely to be treated with several drugs. Because of the possible implications of adverse...
Source: Drug Safety - August 4, 2015 Category: Drugs & Pharmacology Source Type: research

Variation in Association Between Thiazolidinediones and Heart Failure Across Ethnic Groups: Retrospective analysis of Large Healthcare Claims Databases in Six Countries
Conclusion The risk of both oedema and heart failure with thiazolidinediones was higher in predominantly Caucasian countries than in the Asian countries assessed. Assessment of adverse events by ethnicity may support safer medicine use. (Source: Drug Safety)
Source: Drug Safety - July 28, 2015 Category: Drugs & Pharmacology Source Type: research

Erratum to: Methodological Approaches to Evaluate the Impact of FDA Drug Safety Communications
(Source: Drug Safety)
Source: Drug Safety - July 23, 2015 Category: Drugs & Pharmacology Source Type: research

Clinical Pattern of Tolvaptan-Associated Liver Injury in Subjects with Autosomal Dominant Polycystic Kidney Disease: Analysis of Clinical Trials Database
Conclusions Although hepatocellular injury following long-term tolvaptan treatment in ADPKD subjects was infrequent and reversible, the potential for serious irreversible injury exists. Regular monitoring of transaminase levels is warranted in this patient population. (Source: Drug Safety)
Source: Drug Safety - July 19, 2015 Category: Drugs & Pharmacology Source Type: research

Selective Serotonin Reuptake Inhibitor Use and Perioperative Bleeding and Mortality in Patients Undergoing Coronary Artery Bypass Grafting: A Cohort Study
Conclusion In this large cohort study, neither SSRIs nor other antidepressants were associated with elevated rates of major bleed, or in-hospital mortality. (Source: Drug Safety)
Source: Drug Safety - July 19, 2015 Category: Drugs & Pharmacology Source Type: research

Photosensitivity with Angiotensin II Receptor Blockers: A Retrospective Study Using Data from VigiBase ®
Conclusions Photosensitivity reactions have been reported with almost all ARBs in VigiBase® with a positive disproportionality for irbesartan and losartan. Considering that ARBs share the same chemical structure, which may have the same response to sunlight, it is plausible to consider photosensitivity as a possible class effect. Physicians and patients should be aware of potentially serious photosensitivity reactions related to treatment with ARBs. (Source: Drug Safety)
Source: Drug Safety - July 18, 2015 Category: Drugs & Pharmacology Source Type: research

Walking the Fine Line between Science and Culture
(Source: Drug Safety)
Source: Drug Safety - July 15, 2015 Category: Drugs & Pharmacology Source Type: research

Implications of the IQ-CSRC Prospective Study: Time to Revise ICH E14
Abstract Exposure-response (ER) analysis has evolved as an important tool to evaluate the effect of a drug on cardiac repolarization, as reflected in the QTc interval. It has been suggested that careful electrocardiogram (ECG) evaluation in ‘first-in-human’ studies using ER analysis could replace or serve as an alternative to the E14 ‘thorough QT’ study. This commentary shares and discusses the results of a recently conducted study with the objective to evaluate this approach. Six drugs with a well-characterized QT effect, five of which are known QT prolongers, were evaluated in a study des...
Source: Drug Safety - July 11, 2015 Category: Drugs & Pharmacology Source Type: research

Improving Information on Maternal Medication Use by Linking Prescription Data to Congenital Anomaly Registers: A EUROmediCAT Study
Conclusion Linkage of primary care or prescription databases to CA registries improved the quality of information on maternal use of medicines in pregnancy, especially for medicine groups that are less fully registered in CA registries. (Source: Drug Safety)
Source: Drug Safety - July 7, 2015 Category: Drugs & Pharmacology Source Type: research

A Method to Combine Signals from Spontaneous Reporting Systems and Observational Healthcare Data to Detect Adverse Drug Reactions
Conclusions The proposed method resulted in a significant improvement in the accuracy of ADR detection when the resources used for combining had sufficient amounts of data, demonstrating that the method could integrate evidence from multiple sources and serve as a tool in actual pharmacovigilance practice. (Source: Drug Safety)
Source: Drug Safety - July 7, 2015 Category: Drugs & Pharmacology Source Type: research

Hepatotoxicity of New Oral Anticoagulants (NOACs)
The objective of this publication is to summarize the current data about this subject, with a special emphasis on pharmacovigilance data in the World Health Organization (WHO) Global Individual Case Safety Reports (ICSR) database and on potential mechanisms of hepatotoxicity. For that, all available case reports as well as published analyses of clinical studies were obtained with a detailed search in PubMed. In addition, pharmacovigilance data from VigiBase®, the WHO Global ICRS database, were extracted and analyzed. The data show that liver injury associated with NOACs was reported in clinical studies and in pharmacov...
Source: Drug Safety - July 3, 2015 Category: Drugs & Pharmacology Source Type: research

Erratum to: A Comparative Assessment of Observational Medical Outcomes Partnership and Mini-Sentinel Common Data Models and Analytics: Implications for Active Drug Safety Surveillance
(Source: Drug Safety)
Source: Drug Safety - July 2, 2015 Category: Drugs & Pharmacology Source Type: research

Benzodiazepine Use and Risk of Developing Alzheimer’s Disease or Vascular Dementia: A Case–Control Analysis
Abstract Introduction Previous observational studies have associated benzodiazepine use with an increased risk of dementia. However, limitations in the study methods leave questions unanswered regarding the interpretation of the findings. Methods A case–control analysis was conducted using data from the UK-based Clinical Practice Research Datalink (CPRD). A total of 26,459 patients aged ≥65 years with newly diagnosed Alzheimer’s disease (AD) or vascular dementia (VaD) between 1998 and 2013 were identified and matched 1:1 to dementia-f...
Source: Drug Safety - June 30, 2015 Category: Drugs & Pharmacology Source Type: research

The Risk of Opioid Intoxications or Related Events and the Effect of Alcohol-Related Disorders: A Retrospective Cohort Study in German Patients Treated with High-Potency Opioid Analgesics
Conclusions Physicians should be aware of these elevated risks in HPO patients with ARDs. Active patient education by healthcare providers regarding the risk of opioid intoxications or related events due to alcohol in conjunction with HPOs is warranted. (Source: Drug Safety)
Source: Drug Safety - June 29, 2015 Category: Drugs & Pharmacology Source Type: research

Prevalence, Nature, Severity and Risk Factors for Prescribing Errors in Hospital Inpatients: Prospective Study in 20 UK Hospitals
Conclusion The problem of prescribing errors in hospitals is substantial and not solely a problem of the most junior medical prescribers, particularly for those errors most likely to cause significant patient harm. Interventions are needed to target these high-risk errors by all grades of staff and hence improve patient safety. (Source: Drug Safety)
Source: Drug Safety - June 27, 2015 Category: Drugs & Pharmacology Source Type: research

Pharmacogenetics of Drug-Induced QT Interval Prolongation: An Update
Abstract A prolonged QT interval is an important risk factor for ventricular arrhythmias and sudden cardiac death. QT prolongation can be caused by drugs. There are multiple risk factors for drug-induced QT prolongation, including genetic variation. QT prolongation is one of the most common reasons for withdrawal of drugs from the market, despite the fact that these drugs may be beneficial for certain patients and not harmful in every patient. Identifying genetic variants associated with drug-induced QT prolongation might add to tailored pharmacotherapy and prevent beneficial drugs from being withdrawn unnecessari...
Source: Drug Safety - June 25, 2015 Category: Drugs & Pharmacology Source Type: research

Accidents and Incidents Related to Intravenous Drug Administration: A Pre–Post Study Following Implementation of Smart Pumps in a Teaching Hospital
Conclusions We observed no risk reduction associated with the implementation of smart pumps in a 500 bed mother–child hospital. Further studies are required to explore the details of the potential risk reduction associated with the use of smart pumps. (Source: Drug Safety)
Source: Drug Safety - June 25, 2015 Category: Drugs & Pharmacology Source Type: research

Evaluating AE Reporting of Two Off-Patent Biologics to Inform Future Biosimilar Naming and Reporting Practices
Abstract Historical studies of voluntary, spontaneous drug reports show poor attribution of adverse events to generic versions of commonly prescribed medications. As biosimilars enter the market place, it may be similarly difficult to accurately attribute adverse events to their respective reference products. At this time, lack of global consensus with regard to biosimilar naming conventions may result in drug reporting confusion, misattribution of adverse events and insufficient active monitoring of safety signals. Now, with the first biosimilar approval in the USA and many biosimilars expected to be launched glo...
Source: Drug Safety - June 25, 2015 Category: Drugs & Pharmacology Source Type: research

Product-Specific Regulatory Pathways to Approve Generic Drugs: The Need for Follow-up Studies to Ensure Safety and Effectiveness
Abstract Generic drugs possessing the same active ingredients, dosage form, strength, route of administration, and labeling can be approved by the US Food and Drug Administration (FDA) as interchangeable with a brand-name drug without needing to repeat the formal Phase I, II, and III clinical trials conducted by the original manufacturers. In recent years, the FDA has approved several generic drugs using product-specific testing to determine therapeutic equivalence in accordance with the unique features of the particular drug. These have been used in two primary situations: (1) cases for which certain bioequivalen...
Source: Drug Safety - June 24, 2015 Category: Drugs & Pharmacology Source Type: research

Primary Care Medication Safety Surveillance with Integrated Primary and Secondary Care Electronic Health Records: A Cross-Sectional Study
Conclusions Systematic collection, collation, and analysis of linked primary and secondary care records produce plausible and useful information about medication safety for a health system. Medication safety surveillance systems should pay close attention to patient age and polypharmacy with respect to both prescribing and monitoring failures; treat prescribing and monitoring as different statistical processes, rather than a combined measure of prescribing safety; and audit the socio-economic equity of missed monitoring. (Source: Drug Safety)
Source: Drug Safety - June 23, 2015 Category: Drugs & Pharmacology Source Type: research

Changes in Side Effect Risk Communication in Patient Information Leaflets over the Past Decade: Results of a Survey
Conclusion The increased use and consistency of risk descriptors in PILs should benefit patients, particularly those using multiple medicines produced by different market authorisation holders. A need remains for further research evaluating the risk format recommended by the EMA. There is also a need for research evaluating spoken information and other sources of printed risk information about medicines that is available to patients. (Source: Drug Safety)
Source: Drug Safety - June 23, 2015 Category: Drugs & Pharmacology Source Type: research

Detection of Drug–Drug Interactions Inducing Acute Kidney Injury by Electronic Health Records Mining
Conclusion Data mining techniques on CDW can foster the detection of adverse drug reactions when drugs are used alone or in combination. (Source: Drug Safety)
Source: Drug Safety - June 21, 2015 Category: Drugs & Pharmacology Source Type: research

Indigenous Medicine Use for Sex Selection During Pregnancy and Risk of Congenital Malformations: A Population-Based Case-Control Study in Haryana, India
Conclusions The intake of indigenous drugs during pregnancy increased the risk of CMFs almost threefold. This has social as well as economic implications, and hence needs further investigation. (Source: Drug Safety)
Source: Drug Safety - June 20, 2015 Category: Drugs & Pharmacology Source Type: research

Common Models, Different Approaches
(Source: Drug Safety)
Source: Drug Safety - June 19, 2015 Category: Drugs & Pharmacology Source Type: research

DNA Barcoding and Pharmacovigilance of Herbal Medicines
Abstract Pharmacovigilance of herbal medicines relies on the product label information regarding the ingredients and the adherence to good manufacturing practices along the commercialisation chain. Several studies have shown that substitution of plant species occurs in herbal medicines, and this in turn poses a challenge to herbal pharmacovigilance as adverse reactions might be due to adulterated or added ingredients. Authentication of constituents in herbal medicines using analytical chemistry methods can help detect contaminants and toxins, but are often limited or incapable of detecting the source of the contam...
Source: Drug Safety - June 16, 2015 Category: Drugs & Pharmacology Source Type: research

A Comparative Assessment of Observational Medical Outcomes Partnership and Mini-Sentinel Common Data Models and Analytics: Implications for Active Drug Safety Surveillance
Conclusions Differences were observed between OMOP and Mini-Sentinel CDMs. The analysis of both CDMs at the data model level indicated that such conceptual differences had only a slight but not significant impact on identifying known safety associations. Our results show that differences at the ecosystem level of analyses across the CDMs can lead to strikingly different risk estimations, but this can be primarily attributed to the choices of analytic approach and their implementation in the community-developed analytic tools. The opportunities of using CDMs are clear, but our study shows the need for judicious co...
Source: Drug Safety - June 9, 2015 Category: Drugs & Pharmacology Source Type: research

Actual Use of Medications Prescribed During Pregnancy: A Cross-Sectional Study Using Data from a Population-Based Congenital Anomaly Registry
Conclusion Prescription records are generally a relatively reliable source of data for research into associations between medication use in pregnancy and congenital anomalies compared with other data sources. Pharmacy records of medication use in pregnancy might represent an overestimation, which should be taken into account. However, our results show that, except for ‘corticosteroids, dermatological preparations’; ‘ear, eye, nose and throat preparations’; and ‘anxiolytics, hypnotics and sedatives’, this overestimation generally seems minimal. (Source: Drug Safety)
Source: Drug Safety - June 4, 2015 Category: Drugs & Pharmacology Source Type: research

The ISoP CommSIG for Improving Medicinal Product Risk Communication: A New Special Interest Group of the International Society of Pharmacovigilance
(Source: Drug Safety)
Source: Drug Safety - June 1, 2015 Category: Drugs & Pharmacology Source Type: research

Electronic Health Data for Postmarket Surveillance: A Vision Not Realized
Abstract What has been learned about electronic health data as a primary data source for regulatory decisions regarding the harms of drugs? Observational studies with electronic health data for postmarket risk assessment can now be conducted in Europe and the US in patient populations numbering in the tens of millions compared with a few hundred patients in a typical clinical trial. With standard protocols, results can be obtained in a few months; however, extensive research published by scores of investigators has illuminated the many obstacles that prevent obtaining robust, reproducible results that are reliable...
Source: Drug Safety - May 30, 2015 Category: Drugs & Pharmacology Source Type: research

P-Glycoprotein-Mediated Drug Interactions in Pregnancy and Changes in the Risk of Congenital Anomalies: A Case-Reference Study
Conclusions The use of drugs associated with P-gp transport was common during pregnancy. For several drug classes associated with specific anomalies, P-gp-mediated drug interactions are associated with an increased risk for those specific anomalies. (Source: Drug Safety)
Source: Drug Safety - May 29, 2015 Category: Drugs & Pharmacology Source Type: research