7/25/2023 0 Comments Xarelto antidoteUsing the CDC data, QuarterWatch™ estimates that 6.3% of patients exposed to an anticoagulant for 1 year will require an ED visit due to the drug’s adverse effects.Īccording to the CDC study, ED visits for anticoagulant adverse drug effects increased between 14. For comparison, 24.6% of patients were hospitalized after an ED visit linked to the therapeutic use of opioids, and 7.1% were hospitalized after a visit due to an antibiotic reaction. The anticoagulant events were mostly severe, with 48.8% overall requiring hospitalization (63.8% for patients taking dabigatran, 50.4% for rivaroxaban, 48.5% for warfarin). 4 The CDC study showed that anticoagulants accounted for 17.6% of all ED visits for outpatient adverse drug effects, more than any other class of drugs, and 2.4 times more than for opioids used therapeutically. A recently published CDC study of ED visits from 2013 to 2014 associated with adverse drug events confirms and extends these findings. The only other notable adverse effect reported with anticoagulants was renal failure and impairment (n=835).ĬDC study of ED visits. In other cases, the site of bleeding was not identified. Gastrointestinal hemorrhages were the most numerous (n=8,495), but we also identified 1,019 cerebral hemorrhages and another 790 possible cases of cerebral hemorrhage. Practically all reported injuries or deaths were from hemorrhages (n=17,218 78.3%), making bleeding one of the most frequently reported serious adverse drug effects of all types. (Rivaroxaban totals were increased by large numbers of reports with event dates in prior years but first reported to FDA in 2016 reported events for edoxaban were much lower than for the other direct oral anticoagulants and warfarin because of a more restrictive indication and limited patient exposure ). 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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