PubMed Journal Database | Expert opinion on drug safety 
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Showing PubMed Articles 1–25 of 106 from Expert opinion on drug safety
Objective: Progestogens are widely used to treat a large number of common conditions. We aimed to investigate a potential signal concerning progestogens and paraesthesia. Methods: Data were obtained from the VigiBase, the WHO Global Individual Case Safety Reports (ICSR) database, which is maintained by the Uppsala Monitoring Centre. We collected all suspected reports of paraesthesia associated with oral progestogens, reported between January 1972 and June 2012 and classified in VigiBase according to WHO-Adv...
A record 4113 fatalities were reported in 2012 in a postmarketing surveillance of patients treated with deferasirox, despite warnings of life-threatening toxic side effects, and the need for regular monitoring and prophylactic measures. In an EMA report, the mortality rate was estimated at 11.7% and a warning was issued for increasing the dose from 30 to 40 mg/kg/day. In an earlier FDA report of 2474 individual fatality cases, it was revealed that deferasirox was used in many categories of patients. Among t...
Safety evaluation of leflunomide in rheumatoid arthritis.
Introduction: Leflunomide is a prodrug which is rapidly converted following oral administration and absorption to an active metabolite with anti-proliferative effects (A77 1726/teriflunomide). Leflunomide was developed as an immunomodulatory agent and subsequently developed as a disease-modifying anti-rheumatic drug (DMARD) for the management of rheumatoid arthritis (RA). Areas covered: This review article covers the mechanism of action of the drug, clinical indications, including efficacy data from clinica...
Cancer immunotherapies, their safety and toxicity.
Introduction: Cancer immunotherapy encompasses a wide range of treatment modalities that harness the anti-tumor effects of the immune system. Some immunotherapies broadly activate the immune system while others precisely target distinct tumor antigens. Because of this heterogeneity, the side effects associated with immunotherapy can be mild and localized or more severe and systemic. Areas covered: Cytokines, adoptive cellular therapies and vaccines are the most commonly used immunotherapies for the treatmen...
2012 Annual Meeting of the Safety Pharmacology Society: spotlight on targeted oncology medicines.
Introduction: The 12th Annual Meeting of the Safety Pharmacology (SP) Society (SPS) covered various subjects among which safety issues concerning oncolytic drugs are reviewed and discussed in details. Areas covered: The challenges faced by a medical oncologist during the development of new anticancer medicines were the focus of the keynote address. Romidepsin, a drug initially abandoned because of serious cardiotoxicity in dogs, was successfully rescued for clinical evaluation by tailoring the dose regimen...
Introduction: Development of new drugs in oncology may have implications for cardiovascular risk. This report describes some aspects of our growing knowledge in the area of evaluating benefit-risk and may be of direct importance to scientists working in drug discovery and development. Areas covered: This report of webinar highlights entitled "Trends in CardiOncology: the evolution of blood pressure and electrocardiogram (ECG) Markers" covers the current state of pharmacology of selected drugs which induce b...
Introduction: Rasagiline (Azilect, AGN 1135) is a selective irreversible inhibitor of monoamine oxidase B (MAO-B). MAO-B regulates the brain concentrations of important neurotransmitters that are related to movement, emotion, and cognition. Oral rasagiline, as monotherapy or as adjunctive therapy to levodopa, was effective in the symptomatic treatment of adult patients with Parkinson's disease participating in double-blind, placebo-controlled, international studies. Areas covered: This article reviews the r...
Safety and tolerability of paricalcitol in patients with chronic kidney disease.
Introduction: Secondary hyperparathyroidism (SHPT) is a complication of chronic kidney disease (CKD). Beyond skeletal complications, uncontrolled SHPT is associated with cardiovascular mortality. Vitamin D receptor activators (VDRAs) are a mainstay of therapy for SHPT; however, use is limited by hypercalcemia, though less so with calcitriol analogs such as paricalcitol and there is emerging experience with oral formulations for non-SHPT indications. The role of VDRAs in the treatment of SHPT becomes a compl...
Interactions between oral antineoplastic agents and concomitant medication: a systematic review.
Introduction: In recent years, the number of oral antitumoral agents has considerably increased. Oral administration increases the risk of interactions, because most oral anticancer drugs are taken on a daily basis. Interactions can increase exposure to antitumoral agents or cause treatment failure. Many antitumoral drugs undergo enzymatic metabolism by cytochrome P450. As some act as inducers or inhibitors of one or more isoenzymes, they can lead to decreases or increases in plasma concentrations of concom...
Introduction: Ondansetron is a 5-HT3 receptor antagonist commonly used as an antiemetic to prevent nausea and vomiting associated with anti-cancer drugs, cancer radiotherapy or postoperatively. Recently, the US Food and Drug Administration (FDA) issued a warning for ondansetron due to a potential for prolongation of the QT interval of the electrocardiogram (ECG), a phenomenon that is associated with an increased risk of the potentially fatal arrhythmia torsade de pointes. Areas covered: The authors undertoo...
Cardiovascular toxicity of tyrosine kinase inhibitors.
Introduction: Small-molecule tyrosine kinase inhibitors (TKIs) have revolutionized the management of many malignancies. However, they also have been shown to be associated with a certain degree of cardiovascular side effects that are often reversible. Areas covered: As the number of new TKIs continues to grow, it is expected that clinicians will be facing the challenge of early detection and 10 management of these side effects while balancing the risk-benefit ratios of continuing with life-saving cancer the...
Drug safety evaluation of desogestrel.
Introduction: Desogestrel (DSG) is a third-generation progestin. It is commonly used in various formulations for hormonal contraception including combinations with ethinyl estradiol (EE), progestin-only pill and subdermal implants. DSG is also used in menopausal patients for hormone replacement therapy (HRT). Areas covered: The current manuscript aims to review the available data on safety and tolerability of DSG in oral contraception and HRT. The material included in the manuscript was searched and obtaine...
Introduction: An estimated 20 - 40% of cancer patients will develop brain metastases that are the most common intracranial tumors in adults. Patients with cerebral metastases represent a variegate group where selection of the most appropriate treatment depends on many patient- and disease-related factors. The impact of therapeutic option on overall survival is lacking and it is important to consider quality of life (QOL) when treating patients with brain metastases. Areas covered: A considerable proportion...
Oxycodone combined with opioid receptor antagonists: efficacy and safety.
Introduction: A mu receptor antagonist combined with oxycodone (OXY) may improve pain control, reduce physical tolerance and withdrawal, minimizing opioid-related bowel dysfunction and act as an abuse deterrent. Areas covered: The authors cover the use of OXY plus ultra-low-dose naltrexone for analgesia and the use of sustained-release OXY plus sustained-release naloxone to reduce the opioid bowel syndrome. The authors briefly describe the use of sustained-release OXY and naltrexone pellets as a drug abuse...
Objective: To examine real-world safety and treatment patterns of angiogenesis inhibitors for advanced renal cell carcinoma (aRCC) using observational data from two Spanish hospitals. Methods: A retrospective medical record review was performed for 93 patients with a histological diagnosis of aRCC who received sunitinib, sorafenib, bevacizumab or temsirolimus as first-line angiogenesis inhibitor therapy, between January 2005 and September 2010 at two Spanish hospitals. Data were collected on adverse events...
Objective: Further understand the safety profile of celecoxib and provide safety information for important adverse events (AEs). Methods: Analysis of randomized controlled trials from the Pfizer clinical trial repository (final study reports completed by 31 July 2011) in which celecoxib was compared with placebo or non-selective non-steroidal anti-inflammatory drugs (nsNSAIDs) for treatment of pain or inflammation in adults. Safety end points comprised 18 terms that had been identified as important AEs amon...
Objective: To characterize the profile of application site reactions (ASRs) for patients treated with the buprenorphine transdermal system (BTDS) in chronic pain studies. Methods: The incidences of ASRs during treatment with BTDS were examined using (a) integrated data from 16 controlled and uncontrolled Phase III chronic pain studies (N = 6566), (b) a subset of integrated data that focused on the double-blind phases of five enriched, placebo-controlled studies (n = 1806) and (c) data from an international...
Clinical and causality assessment in herbal hepatotoxicity.
Introduction: Herbal hepatotoxicity represents a poorly understood, neglected and multifaceted disease with numerous confounding variables and missing established causality in the majority of cases. This review discusses overt shortcomings in its clinical and causality assessment and suggests improvements. Areas covered: A selective literature search of PubMed using the terms herbal hepatotoxicity, herb-induced liver injury, drug hepatotoxicity and drug-induced liver injury was performed to identify publish...
Lenalidomide and thalidomide in the treatment of chronic pain.
Introduction: The immunomodulatory and anti-inflammatory drug thalidomide was first introduced in 1957 as a sleep aid and treatment for morning sickness. It was subsequently removed from the market due to severe teratogenic side effects and then returned to the market as a treatment for myelodysplastic syndrome and multiple myeloma. Lenalidomide is an analog of thalidomide with similar efficacy but improved side-effect profile. There are reports and studies of both agents for the treatment of chronic pain,...
Sertindole: dilemmas for its use in clinical practice.
Introduction: Sertindole was taken off the market by its manufacturer in 1998 due to concerns of its association with prolongation of QT intervals and serious dysrhythmia. After extensive post-marketing analysis and epidemiological studies regarding its safety, sertindole was relaunched in Europe in 2005. Areas covered: Sertindole is an efficacious antipsychotic that possesses superior efficacy compared with haloperidol, similar efficacy compared with risperidone, and slightly inferior efficacy compared wit...
The in vitro and in vivo effects of nicotine on bone, bone cells and fracture repair.
Introduction: Cigarette smoke has negative effects on bone metabolism and fracture repair. However, no study has reviewed effects of nicotine on bone and fracture repair independent of other constituents of cigarette smoke. The authors review the existing evidence of the effect of nicotine on 'bone' and 'bone cells' and fracture repair, drawing conclusions relevant to clinical practice and future research. Areas covered: A literature review was conducted using PRISMA guidelines and PubMed, Cochrane, MEDLINE...
Glargine safety, diabetes and cancer.
Introduction: In 2009, several epidemiological studies suggested a higher frequency of malignancy in insulin glargine -treated patients. A number of follow-up epidemiological population studies as well as two randomized, controlled clinical studies, one a 5000-patient retinopathy study and the other a 12,000-patient cardiovascular outcomes trial (ORIGIN), found no higher frequency of malignancy in glargine-treated patients. Areas covered: We reviewed the existing literature as well as U.S. FDA records to in...
The path to approval of new drugs for diabetes.
Introduction: The evaluation of agents to treat elevated blood glucose is straightforward and is accomplished with short duration studies, but it is more difficult to demonstrate safety of these agents over long periods of clinical use. Numerous large studies have raised questions as to the cardiovascular risks of certain drugs such as the thiazolidinediones and even challenged the wisdom of aggressive attempts to normalize plasma glucose. As a result of this uncertainty, the FDA issued new Guidance to Indu...
Dronedarone: is it time to turn it down?
Saxagliptin overview: special focus on safety and adverse effects.
Introduction: Saxagliptin (see drug summary box) is a glucose-lowering agent that belongs to the class of Dipeptidylpeptidase-4 (DDP-4) inhibitors used in the treatment of T2DM. Clinical efficacy of saxagliptin as single agent as well as in combination with other medications used for the treatment of T2DM has been well established in several randomized trials. Treatment with saxagliptin is effective, generally safe and well tolerated, apart from a small increase in the incidence of infections such as nasoph...
