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Drug Updates

Michele B. Kaufman, PharmD, BCGP  |  Issue: March 2009  |  March 1, 2009

BPs and Atrial Fibrillation: In November, the FDA reported on evaluated data regarding the potential increased risk of atrial fibrillation in patients treated with BPs.7 Data reviewed included that of 19,687 BP-treated patients and 18,358 placebo-treated patients who were followed for six months to three years.8 The FDA has found no clear relationship between BP use and the rate of any type of atrial fibrillation.

According to a study presented at the American Heart Association meeting in November 2008, utilizing proton pump inhibitors (PPIs) along with clopidogrel may increase the risk of major cardiovascular (CV) events (e.g., stroke, hospitalization, angina, myocardial infarction or coronary bypass graft).9 A retrospective cohort of patients (n=14,383) that received clopidogrel to prevent coronary stent re-thrombosis during the year 2005–2006 was evaluated. Patients were followed for the one-year incidence of major adverse CV events in those that took clopidogrel alone (n=9,862) compared with those that took clopidogrel and a PPI (n=4,521). In patients with no preceding CV events, the incidence of a major CV event was 33% in those who took a PPI with clopidogrel versus 21% in those who did not. A more distinct effect was seen in patients with a prior CV event. The risk of a major CV event was 50% higher and the relative risk for a myocardial infarction was 74% higher in the patients taking both drugs together. The FDA’s clinical pharmacology division is evaluating how the two drug classes can be safely used together.10

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A Web Site to Help Prevent Medication Errors

A new Web site was developed by the Institute for Safe Medication Practices (ISMP) to empower patients and the healthcare community to prevent medication errors and adverse drug events.11 Through this new site, the ISMP hopes to collect and analyze reports of medication-related problems (MRPs); disseminate timely medication safety information; educate consumers and healthcare providers; collaborate with other groups to improve medication safety; promote adopting safe medication standards by accrediting bodies, manufacturers, policy makers, regulatory agencies, etc.; and other related endeavors. There is a user-friendly tool to directly report medication errors or adverse drug reactions (by the patient or the healthcare provider). Alerts can be customized to include a list of commonly used medications or a patient’s own medications, or it can be checked for individual patients prior to prescribing. The site and alerts routinely check the safety of medications and screen for drug–drug and drug–disease interactions to help patients and their healthcare providers keep abreast of changing drug information.

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Filed under:Drug Updates Tagged with:ApprovalsPipeline

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