Upcoming drug safety and pharmacovigilance conferences 2016/2016
(Source: Therapeutic Advances in Drug Safety)
Source: Therapeutic Advances in Drug Safety - September 30, 2015 Category: Drugs & Pharmacology Tags: Upcoming Conferences Source Type: research

Abuse-deterrent formulations: transitioning the pharmaceutical market to improve public health and safety--reply
(Source: Therapeutic Advances in Drug Safety)
Source: Therapeutic Advances in Drug Safety - September 30, 2015 Category: Drugs & Pharmacology Authors: Simon, K. Tags: Letters to the editor Source Type: research

Abuse-deterrent formulations: transitioning the pharmaceutical market to improve public health and safety
(Source: Therapeutic Advances in Drug Safety)
Source: Therapeutic Advances in Drug Safety - September 30, 2015 Category: Drugs & Pharmacology Authors: Ruan, X., Kaye, A. D. Tags: Letters to the editor Source Type: research

Suvorexant in insomnia: efficacy, safety and place in therapy
Insomnia is a highly prevalent disorder that can occur in conjunction with other medical or psychiatric conditions or can occur in the absence of a coexisting disorder. Regardless, treatment of insomnia is beneficial to the patient and may benefit comorbidities if they exist. Nonpharmacologic modalities such as sleep hygiene and stimulus controls are important mainstays of insomnia therapy, but may not be sufficient to treat the disorder. Dual orexin receptor antagonists (DORAs) are a new class of insomnia medication that target wakefulness-promoting neuropeptides to regulate the sleep–wake cycle. Suvorexant is the f...
Source: Therapeutic Advances in Drug Safety - September 30, 2015 Category: Drugs & Pharmacology Authors: Rhyne, D. N., Anderson, S. L. Tags: Review Source Type: research

Pharmacists in Australian general practice: an opportunity for expertise in precision medicine
(Source: Therapeutic Advances in Drug Safety)
Source: Therapeutic Advances in Drug Safety - September 30, 2015 Category: Drugs & Pharmacology Authors: Polasek, T. M., Rowland, A., Wiese, M. D., Sorich, M. J. Tags: Editorial Source Type: research

hERG potassium channel inhibition by ivabradine may contribute to QT prolongation and risk of torsades de pointes
(Source: Therapeutic Advances in Drug Safety)
Source: Therapeutic Advances in Drug Safety - July 26, 2015 Category: Drugs & Pharmacology Authors: Hancox, J. C., Melgari, D., Dempsey, C. E., Brack, K. E., Mitcheson, J., Ng, G. A. Tags: Letter to the editor Source Type: research

Combination use of medicines from two classes of renin-angiotensin system blocking agents: risk of hyperkalemia, hypotension, and impaired renal function
European and United States regulatory agencies recently issued warnings against the use of dual renin–angiotensin system (RAS) blockade therapy through the combined use of angiotensin-converting enzyme inhibitors (ACEIs), angiotensin II receptor blockers (ARBs) or aliskiren in any patient, based on absence of benefit for most patients and increased risk of hyperkalemia, hypotension, and renal failure. Special emphasis was made not to use these combinations in patients with diabetic nephropathy. The door was left open to therapy individualization, especially for patients with heart failure, when the combined use of an...
Source: Therapeutic Advances in Drug Safety - July 26, 2015 Category: Drugs & Pharmacology Authors: Esteras, R., Perez-Gomez, M. V., Rodriguez-Osorio, L., Ortiz, A., Fernandez-Fernandez, B. Tags: Reviews Source Type: research

Anti-dementia medications: current prescriptions in clinical practice and new agents in progress
Almost three decades after the publication of the first clinical studies with tacrine, the pharmacological treatment of Alzheimer’s disease (AD) remains a challenge. Randomized clinical trials have yielded evidence of significant – although modest and transient – benefit from cholinergic replacement therapy for people diagnosed with AD, and disease modification with antidementia compounds is still an urgent, unmet need. The natural history of AD is very long, and its pharmacological treatment must acknowledge different needs according to the stage of the disease process. Cognitive and functional deteriora...
Source: Therapeutic Advances in Drug Safety - July 26, 2015 Category: Drugs & Pharmacology Authors: Stella, F., Radanovic, M., Canineu, P. R., de Paula, V. J. R., Forlenza, O. V. Tags: Reviews Source Type: research

Coming safely to a stop: a review of platelet activity after cessation of antiplatelet drugs
The platelet P2Y12 antagonists are widely used, usually in combination with aspirin, to prevent atherothrombotic events in patients with acute coronary syndromes during percutaneous coronary intervention and after placement of arterial stents. Inhibition by clopidogrel or prasugrel lasts for the lifetime of the affected platelets and platelet haemostatic function gradually recovers after stopping the drug, as new unaffected platelets are formed. The optimal durations for dual antiplatelet therapy are prescribed by clinical guidelines. Continuation beyond the recommended duration is associated with an increased mortality, m...
Source: Therapeutic Advances in Drug Safety - July 26, 2015 Category: Drugs & Pharmacology Authors: Ford, I. Tags: Reviews Source Type: research

European Union pharmacovigilance capabilities: potential for the new legislation
European Directives and Regulations introduced between late 2010 and 2012 have substantially overhauled pharmacovigilance processes across the European Union (EU). In this review, the implementation of the pharmacovigilance legislative framework by EU regulators is examined with the aim of mapping Directive 2010/84/EU and Regulation EC No. 1235/2010 against their aspired objectives of strengthening and rationalizing pharmacovigilance in the EU. A comprehensive review of the current state of affairs of the progress made by EU regulators is presented in this paper. Our review shows that intense efforts by regulators and indu...
Source: Therapeutic Advances in Drug Safety - July 26, 2015 Category: Drugs & Pharmacology Authors: Borg, J. J., Tanti, A., Kouvelas, D., Lungu, C., Pirozynski, M., Serracino-Inglott, A., Aislaitner, G. Tags: Reviews Source Type: research

Risk of intracranial hypertension with intrauterine levonorgestrel
Conclusion: We found a higher than expected number of reports of ICH with Mirena® in the FAERS database. We also found a similar risk of ICH with Mirena® compared with the oral contraceptive EE-norgestimate. The higher risk of ICH with EE-norethindrone, another oral contraceptive should be further investigated. (Source: Therapeutic Advances in Drug Safety)
Source: Therapeutic Advances in Drug Safety - June 10, 2015 Category: Drugs & Pharmacology Authors: Etminan, M., Luo, H., Gustafson, P. Tags: Original Research Source Type: research

Safety risks with investigational drugs: Pharmacy practices and perceptions in the veterans affairs health system
Conclusions: Medication safety concerns exist among pharmacists in an investigational drug service; however, a variety of measures have been employed to improve medication safety practices. Best practices for the safe dispensing of investigational medications should be developed in order to standardize these error-prevention strategies. (Source: Therapeutic Advances in Drug Safety)
Source: Therapeutic Advances in Drug Safety - June 10, 2015 Category: Drugs & Pharmacology Authors: Cruz, J. L., Brown, J. N. Tags: Original Research Source Type: research

Right ventricle failure associated wıth trastuzumab
Trastuzumab (TZ), a monoclonal antibody against human epidermal growth factor receptor type 2 (HER2), is an important biological agent used for the treatment of positive breast cancer. This paper presents a 46-year-old female patient who developed right heart failure and right ventricular dysfunction while on TZ due to breast cancer, and returned to normal following the discontinuation of the drug. As far as we know, this is the first case report related to a patient presenting with right ventricular dysfunction and induced cardiotoxicity while on TZ. (Source: Therapeutic Advances in Drug Safety)
Source: Therapeutic Advances in Drug Safety - June 10, 2015 Category: Drugs & Pharmacology Authors: Bayar, N., Kucukseymen, S., Goktaş, S., Arslan, Şakir Tags: Original Research Source Type: research

A randomized, crossover, placebo-controlled clinical trial to assess the sensitivity of the CRCDS Mini-Sim to the next-day residual effects of zopiclone
Conclusions: Further validation of the CRCDS Mini-Sim is warranted to develop this platform for drug safety studies. (Source: Therapeutic Advances in Drug Safety)
Source: Therapeutic Advances in Drug Safety - June 10, 2015 Category: Drugs & Pharmacology Authors: Simen, A. A., Gargano, C., Cha, J.-H., Drexel, M., Bautmans, A., Heirman, I., Laethem, T., Hochadel, T., Gheyle, L., Bleys, K., Beals, C., Stoch, A., Kay, G. G., Struyk, A. Tags: Original Research Source Type: research

Abuse-deterrent formulations: transitioning the pharmaceutical market to improve public health and safety
This article evaluates abuse-deterrent formulations (ADFs) as a method to reduce prescription drug abuse while ensuring access to vital medications for individuals with legitimate need; assesses the pros and cons of ADFs and the current state of ADF adoption in the market; and develops policy recommendations to transition the market to ADFs. Although abuse-deterrent technology is still in its nascent stages, ADFs have been proven to reduce prescription drug abuse and its consequences, and even an incremental reduction in abuse can have a significant impact on the nation by reducing the costly social, physical, mental, and ...
Source: Therapeutic Advances in Drug Safety - April 6, 2015 Category: Drugs & Pharmacology Authors: Simon, K., Worthy, S. L., Barnes, M. C., Tarbell, B. Tags: Reviews Source Type: research