QuarterWatch 2011 Quarter 2: More Pradaxa Adverse Events Reported Than Any Other Regularly Monitored Drug
The developing drug safety controversy involving the anticoagulation drug Pradaxa (dabigatran) has been presented best, perhaps, by the ISMP QuarterWatch publication, which served as the basis for these two past articles about the problems with Pradaxa:
(1) New Heart Drug Pradaxa May Be Sending "Early" Drug Safety Signals -- ISMP QuarterWatch 2010 4th Quarter: Hemorrhages And Thromboembolic Events Have Been Reported To FDA
(2) Pradaxa: Excess Number Of Severe Bleeding Events In Certain Patient Populations And Settings -- At Increased Risk Are Patients Who Are Older, Have Altered Renal Clearance, Or Undergoing Atrial Fibrillation (AF) Ablation (citing the ISMP QuarterWatch 2011 Quarter 1 edition)
And the latest Pradaxa safety "update" comes from ISMP QuarterWatch 2011 Quarter 2 (PDF), which was released April 5, 2012:
[(Pradaxa (dabigatran)] a new anticoagulant intended to reduce the risk of stroke, was a suspect drug in 856 reported cases, more than any other regularly monitored drug, but showed a decrease from 931 reports in the previous quarter. The new quarterly total included 117 reported patient deaths. With 511 reported cases of hemorrhage, and a median patient age of 80 years, these new bleeding reports reinforce our concern that vulnerable older patients may be receiving an overdose of this one-size-fits-all drug.
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To provide a typical example of what type of patient is experiencing serious side effects associated with Pradaxa, we turn to "Dabigatran-Induced Gastrointestinal Bleeding in an Elderly Patient with Moderate Renal Impairment", a case report article published online April 10, 2012 by The Annals of Pharmacotherapy. In relevant part, from the Asbtract for this report:
OBJECTIVE: To report a case of dabigatran-induced overanticoagulation in a patient who developed acute renal failure and to inform health care providers of the need for appropriate patient selection and periodic monitoring of renal function in the elderly.
CASE SUMMARY: A 66-year-old woman treated with dabigatran for atrial fibrillation developed acute renal failure and upper gastrointestinal bleeding. She had been taking dabigatran 150 mg twice daily for 2 months, with intermittent renal insufficiency during the previous 6 months.... Her renal function never recovered and she remained hemodialysis-dependent. After a 47-day length of stay, she was transferred to a nursing home where she died 2 months later.
DISCUSSION: Renally eliminated drugs such as dabigatran place elderly patients at increased risk of drug accumulation and adverse drug events due to age-related decline in renal function.... In our patient, the Naranjo probability scale indicated a probable cause between the bleeding event and dabigatran use.
Our thanks to the ISMP QuarterWatch publication for staying on top of this Pradaxa safety story, which we will continue to follow and report on, here.
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