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Bleeding risk with systemic thrombolytic therapy for pulmonary embolism: scope of the problem
The objective of this perspective article is to evaluate the bleeding risk associated with systemic thrombolytic therapy in the management of acute pulmonary embolism and discuss strategies to minimize this risk. Risk stratification of acute pulmonary embolism will be discussed to identify patient populations that warrant specific consideration of risk for major bleeding with thrombolytic therapy. In addition, the incidence, patient-specific risk factors, and pharmacologic characteristics, including concurrent anticoagulation and thrombolytic therapy, will be evaluated in the context of risk for major hemorrhage. Finally, ...
Source: Therapeutic Advances in Drug Safety - April 6, 2015 Category: Drugs & Pharmacology Authors: Daley, M. J., Murthy, M. S., Peterson, E. J. Tags: Reviews Source Type: research

Menopausal hormone therapy and breast cancer mortality: clinical implications
The Women’s Health Initiative (WHI) has conducted two randomized, placebo-controlled clinical trials to evaluate the influence of menopausal hormone therapy on chronic disease risk. Estrogen plus progestin was evaluated in 16,608 postmenopausal women without prior hysterectomy during 5.6 years’ intervention. In that setting, combined hormone therapy use significantly increased breast cancer incidence and interfered with breast cancer detection. The breast cancers were not limited to estrogen receptor positive, favorable prognosis cancers and were identified at more advanced stage. As a result, deaths from breas...
Source: Therapeutic Advances in Drug Safety - April 6, 2015 Category: Drugs & Pharmacology Authors: Chlebowski, R. T., Anderson, G. L. Tags: Reviews Source Type: research

Published cases of adverse drug reactions: has the quality of reporting improved over time?
Conclusion: Progress has been made in ADR case reporting quality for a variety of journals, but more improvement is required to ensure data are understandable and relatable to patient care. (Source: Therapeutic Advances in Drug Safety)
Source: Therapeutic Advances in Drug Safety - April 6, 2015 Category: Drugs & Pharmacology Authors: Kane-Gill, S. L., Smithburger, P. L., Williams, E. A., Felton, M. A., Wang, N., Seybert, A. L. Tags: Original Research Source Type: research

Review of naloxone safety for opioid overdose: practical considerations for new technology and expanded public access
Opioid overdose and mortality have increased at an alarming rate prompting new public health initiatives to reduce drug poisoning. One initiative is to expand access to the opioid antidote naloxone. Naloxone has a long history of safe and effective use by organized healthcare systems and providers in the treatment of opioid overdose by paramedics/emergency medicine technicians, emergency medicine physicians and anesthesiologists. The safety of naloxone in a prehospital setting administered by nonhealthcare professionals has not been formally established but will likely parallel medically supervised experiences. Naloxone do...
Source: Therapeutic Advances in Drug Safety - January 26, 2015 Category: Drugs & Pharmacology Authors: Wermeling, D. P. Tags: Reviews Source Type: research

New antiepileptic medication linked to blue discoloration of the skin and eyes
Ezogabine is an antiepileptic medication approved in June 2011 by the US Food and Drug Administration (FDA) as an adjunctive treatment for partial seizures. Minimal drug interactions and a novel mechanism of action made ezogabine an appealing new treatment option. However, adverse effects reported during clinical trials and following drug approval have been alarming. A Risk Evaluation Mitigation Strategy (REMS) program has been established for urinary retention. A safety alert was published in April 2013 warning ezogabine may cause retinal pigment abnormalities and/or blue-gray discoloration, most notably on or near the li...
Source: Therapeutic Advances in Drug Safety - January 26, 2015 Category: Drugs & Pharmacology Authors: Clark, S., Antell, A., Kaufman, K. Tags: Reviews Source Type: research

Targeting precision medicine toxicity: recent developments
(Source: Therapeutic Advances in Drug Safety)
Source: Therapeutic Advances in Drug Safety - January 26, 2015 Category: Drugs & Pharmacology Authors: Mallarkey, G., Mangoni, A. A. Tags: Editorial Source Type: research

Dapagliflozin efficacy and safety: a perspective review
Type 2 diabetes mellitus is a prevalent, progressive disease with a need for innovative therapeutic agents to continue to advance disease management. Dapagliflozin is the second agent in a new class of oral antihyperglycemic drugs: sodium-glucose cotransporter 2 (SGLT2) inhibitors. SGLT2 is responsible for the majority of renal glucose reuptake; inhibition of the cotransporter allows for increased renal glucose excretion that consequently leads to reduced plasma glucose levels. Because this mechanism does not require the action of insulin, dapagliflozin rarely causes hypoglycemia and is effective in patients both early and...
Source: Therapeutic Advances in Drug Safety - November 13, 2014 Category: Drugs & Pharmacology Authors: Anderson, S. L. Tags: Reviews Source Type: research

Antimicrobial resistance: risk associated with antibiotic overuse and initiatives to reduce the problem
Antimicrobial resistance is a global public health challenge, which has accelerated by the overuse of antibiotics worldwide. Increased antimicrobial resistance is the cause of severe infections, complications, longer hospital stays and increased mortality. Overprescribing of antibiotics is associated with an increased risk of adverse effects, more frequent re-attendance and increased medicalization of self-limiting conditions. Antibiotic overprescribing is a particular problem in primary care, where viruses cause most infections. About 90% of all antibiotic prescriptions are issued by general practitioners, and respiratory...
Source: Therapeutic Advances in Drug Safety - November 13, 2014 Category: Drugs & Pharmacology Authors: Llor, C., Bjerrum, L. Tags: Reviews Source Type: research

Patients' perspectives regarding long-term warfarin therapy and the potential transition to new oral anticoagulant therapy
Conclusion: When considering potential transition from VKAs to NOACs it is important for prescribers to consider that some patients, in particular those from a rural location, may not perceive a significant benefit in transitioning or may have particular concerns in this area. (Source: Therapeutic Advances in Drug Safety)
Source: Therapeutic Advances in Drug Safety - November 13, 2014 Category: Drugs & Pharmacology Authors: Gebler-Hughes, E. S., Kemp, L., Bond, M. J. Tags: Original Research Source Type: research

Combined hormonal contraceptives: prescribing patterns, compliance, and benefits versus risks
Combined hormonal contraceptives [combined oral contraceptives (COCs)] have been available for over 50 years and the impact of this invention may not be overestimated. Today over 100 million women are current users and in Western Europe and the United States approximately 80% of women of fertile ages can be considered as ever-users. Over the years several drawbacks have been identified and media alarms on risks are frequently presented, resulting in suboptimal compliance and low compliance and continuation rates. Poor compliance and discontinuation is a big problem and is not generally identified by prescribers. During ide...
Source: Therapeutic Advances in Drug Safety - September 18, 2014 Category: Drugs & Pharmacology Authors: Brynhildsen, J. Tags: Reviews Source Type: research

Adverse effects of testosterone replacement therapy: an update on the evidence and controversy
Testosterone replacement therapy (TRT) has been used in millions of men worldwide to treat diminished libido and erectile dysfunction, and to improve strength and physical function. The estimated likelihood of adverse effects of long-term TRT is still essentially unknown, as overall high-quality evidence based upon prospective randomized trials to recommend for or against its use in most men with testosterone deficiency (TD) is lacking. Evidence to suggest that TRT increases cardiovascular morbidity and mortality risks is poor, as results vary across study populations and their baseline comorbidities. While TRT may increas...
Source: Therapeutic Advances in Drug Safety - September 18, 2014 Category: Drugs & Pharmacology Authors: Grech, A., Breck, J., Heidelbaugh, J. Tags: Reviews Source Type: research

Quantification of active pharmaceutical ingredient and impurities in sildenafil citrate obtained from the Internet
Conclusions: Quality assurance tests are often used to detect formulation defects of drug products during the manufacturing and/or storage process. Results suggest that manufacturing standards for sildenafil citrate generic drug products compared with the US innovator product are not equivalent with regards to potency and levels of impurities. These findings have implications for safety and effectiveness that should be addressed by clinicians to safeguard consumers who choose to purchase sildenafil citrate and foreign-manufactured drugs, in general, via the Internet. (Source: Therapeutic Advances in Drug Safety)
Source: Therapeutic Advances in Drug Safety - September 18, 2014 Category: Drugs & Pharmacology Authors: Veronin, M. A., Nutan, M. T., Dodla, U. K. R. Tags: Original Research Source Type: research

The consequences of nonprescription medication sales in Saudi Arabia's community pharmacies: regulations without implementation
(Source: Therapeutic Advances in Drug Safety)
Source: Therapeutic Advances in Drug Safety - July 1, 2014 Category: Drugs & Pharmacology Authors: Khan, T. M. Tags: Letter to the Editor Source Type: research

Varenicline and cardiovascular adverse events: a perspective review
Smoking is a leading preventable cause of mortality and morbidity. Varenicline, a first-line smoking cessation aid, is used widely to achieve successful quit rates in smokers. A number of studies and systematic reviews have evaluated the safety profile of the drug. To date, three systematic reviews by Singh and colleagues, Prochaska and Hilton, and Ware and colleagues, published between 2011 and 2013, have evaluated serious cardiovascular adverse events with varenicline use. Even though all three reviews demonstrated that serious cardiovascular adverse events were nominally more frequent in varenicline-treated patients whe...
Source: Therapeutic Advances in Drug Safety - July 1, 2014 Category: Drugs & Pharmacology Authors: Chelladurai, Y., Singh, S. Tags: Reviews Source Type: research

Cardiovascular toxicity associated with adjuvant trastuzumab therapy: prevalence, patient characteristics, and risk factors
Before the advent of the human epidermal growth factor receptor 2 (HER2)-targeted monoclonal antibody trastuzumab, HER2-positive breast cancers were difficult to treat and had a poor prognosis. Adjuvant trastuzumab is now an important part of the treatment regimen for many women with HER2-positive breast cancer and has undoubtedly resulted in a significant improvement in prognosis, but it is associated with a risk for cardiotoxicity. In this review, we describe the prevalence, patient characteristics, and risk factors for cardiotoxicity associated with use of adjuvant trastuzumab. Understanding risk factors for trastuzumab...
Source: Therapeutic Advances in Drug Safety - July 1, 2014 Category: Drugs & Pharmacology Authors: Onitilo, A. A., Engel, J. M., Stankowski, R. V. Tags: Reviews Source Type: research