The primary suspect drugs were rivaroxaban In the 2016 data, anticoagulants continue to account for large numbers of reported serious injuries (n=18,978) and deaths (n=3,018) in the US. 4 The CDC data show that adverse effects of oral anticoagulants account for more ED visits than any other class of drugs. Reports of serious injuries and death also feature prominently in the 2016 FAERS data, as well as in a systematic study of emergency department (ED) visits for adverse drug events conducted by the Centers for Disease Control and Prevention (CDC) and published in late 2016. Overall exposure to oral anticoagulants increased 2.6% between the 4th quarter of 2015 and the same quarter in 2016 (see Table 1). ![]() ![]() 1-3 Next, anticoagulants are used by a large and growing population, notably the elderly, with an estimated 3.8 million person-years exposure by the end of 2016 based on outpatient prescription data from QuintilesIMS. First, in clinical trials, these drugs have repeatedly demonstrated high injury rates, causing bleeding in 8% to 19% of patients treated for a year. Harm from oral anticoagulants ranks as one of the highest priority drug safety problems in 2016 by several measures. In Part II, we examine the high risk of acute injuries linked to oral anticoagulants and outline five practical measures to improve safe use. ![]() Part I of this newsletter feature, which appeared in the Jissue, examined drug withdrawal symptoms reported by large populations of patients who have stopped taking opioids, antidepressants, and certain neuropathic pain, antianxiety, and sedative/hypnotic medications. The latest annual report of ISMP’s QuarterWatch™ analyzes more than 1.2 million new adverse drug event reports submitted to the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) during 2016.
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