Expert opinion on drug safety
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Expert Opin Drug Saf · Jun 2018
Local anesthetics systemic toxicity association with exparel (bupivacaine liposome)- a pharmacovigilance evaluation.
Local anesthetic systemic toxicity (last) is a rare life threatening complication usually from intra-arterial or intravenous injection leading to systemic absorption of regional anesthesia drug. the objective of this research was to statistically quantify the association between exparel (bupivacaine liposome) injectable suspension and last. ⋯ The health care provider, including anesthetists, should be made aware that as with bupivacaine HCl, Local Anesthetic Systemic Toxicity, including seizures and cardiac arrest, could be induced by Exparel as well.
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Expert Opin Drug Saf · Jun 2018
ReviewThe safety of trifluridine and tipiracil for the treatment of metastatic colorectal cancer.
TAS102 is an oral thymidine-based nucleoside analog that has been approved for the treatment of patients with metastatic colorectal cancer (mCRC) previously treated with, or not candidates for, available therapies including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, anti-vascular endothelial growth factor (VEGF) agents and, if RAS wild-type, anti-epidermal growth factor receptor (EGFR) therapy. The pivotal RECOURSE phase III trial demonstrated a significant improvement in disease control rate, progression-free survival (PFS), and overall survival (OS) as compared with placebo in patients with refractory mCRC. ⋯ Expert opinion: TAS102 significantly improves survival of patients with refractory mCRC and has manageable toxicity. An expanding role in the treatment of CRC is expected for TAS102 in the near future, as its favorable safety profile makes TAS102 a suitable drug to be combined with other cytotoxic and targeted agents.
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Expert Opin Drug Saf · Jun 2018
Comparative StudyA comparison of approaches to identify possible cases of local anesthetic systemic toxicity in the FDA Adverse Event Reporting System (FAERS) database.
Local anesthetic systemic toxicity (LAST) is a rare but potentially serious adverse event . ⋯ Our findings suggest the estimated incidence of possible LAST cases with LB is similar to, or less than, the reported incidence with other injectable local anesthetics.
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Expert Opin Drug Saf · May 2018
Review Meta AnalysisThe tolerability and safety profile of patiromer: a novel polymer-based potassium binder for the treatment of hyperkalemia.
Hyperkalemia (HK) occurs often among patients with chronic kidney disease (CKD) and heart failure (HF) and those treated with renin-angiotensin-aldosterone system inhibitors (RAASI). Even small deviations from normal potassium levels carry increased risk of mortality. Patiromer is approved for treatment of HK and has been shown in clinical trials to reduce serum potassium among patients with HK and comorbid conditions. ⋯ Patiromer effectively reduces serum potassium, and gastrointestinal adverse events (AEs) are the most common patiromer-associated AEs. Effective management of HK with patiromer may allow use of RAASI at optimal doses as recommended by treatment guidelines. Future research should examine the potential for potassium binders, including patiromer, to extend use of RAASI in appropriate patient populations.
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Expert Opin Drug Saf · May 2018
Policies to mitigate nonmedical use of prescription medications: how should emerging evidence of gabapentin misuse be addressed?
Over the past decade, increased prescription supply has facilitated an epidemic of nonmedical use of controlled substances, including predominantly opioids, as well as benzodiazepines, z-hypnotics, and stimulants. Areas covered: More recently, misuse of noncontrolled prescriptions, such as gabapentin, has been detected. Gabapentin misuse has been associated with drug-related harm and increased healthcare service utilization in a few studies, including a recent large-sample analysis of commercially insured enrollees in the United States (U. ⋯ S. states have acted to prevent or detect gabapentin misuse by requiring the inclusion of gabapentin utilization in reporting to local Prescription Drug Monitoring Programs (PDMPs) and/or imposing other restrictions on gabapentin prescribing (e.g., classification as a controlled substance, quantity limits). These efforts may result in unintentional harm by (1) encouraging 'doctor shopping' across state lines to seek lenient regulatory policies and (2) placing the burden for mitigating misuse on individual practitioners. Expert opinion: We call for a unified national approach, comprising federal regulation and enhanced PDMP reporting to address gabapentin misuse, while laying the groundwork for management of new medications of abuse that the healthcare industry may encounter in the future.