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Steven Davis
Steven Davis
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Pradaxa – Are We Human Guinea Pigs?

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Reports of adverse events continue to mount among users of Pradaxa, a new drug approved to reduce the risk of stroke by inhibiting blood coagulation. A new study identified more than 500 reports of fatal, disabling, or other severe hemorrhages. Last month, Boehringer Ingelheim acknowledged 260 deaths from serious bleeding, and published yesterday was a study showing an increased risk of heart attacks associated with Pradaxa. The FDA is studying these reports, but has not yet taken action.

Following on the heels of the other reports, the Institute for Safe Medication Practices (ISMP), a nonprofit organization educating the healthcare community and consumers about safe medication practices, now suggests that Pradaxas adverse effects in high risk patients deserves to be a national priority as a result of its examination of the FDA MedWatch Reports from the first quarter of 2011 for dabigatran (Pradaxa).

ISMP publishes “Quarter Watch”, an independent publication that monitors all domestic serious adverse drug events reported to the FDA. As we reported last month, the FDA asked anyone experiencing adverse events involving Pradaxa to contact the FDA MedWatch program and fill out a voluntary form under the Adverse Event Reporting System (AERS) that could be used to help the FDA could make an informed decision about the safety of Pradaxa. The information provided by individuals supplements the adverse event information the FDA collects from health professionals and from the manufacturer.

ISMP analyzed 932 serious adverse event reports specifically coded as "serious" and submitted to the FDA under this process from the first quarter of 2011. According to ISMP, of the 932 serious cases involving Pradaxa, 120 cases resulted in death to the patient, 25 cases resulted in permanent disability and 543 cases required hospitalization.

ISMP saw evidence suggesting that some of the oldest patients may experience severe bleeds resulting in harm, rather than benefits, because of the one-size-fits-all dosing regimen of Pradaxa. The evidence gathered suggests that the oldest patients may require a lower dosage, which is currently unavailable. Furthermore, Pradaxa does not offer tools to individualize blood levels, patients are not routinely monitored to see if they are getting too much drug, and there is no readily available antidote like vitamin K for warfarin overdoses.

Boehringer Ingelheim has gained market share with Pradaxa as a therapeutic simplification compared to warfarin. A drug that is easier to use because it doesn't require weekly or monthly laboratory tests to individualize doses may be appealing to physicians and patients, but it certainly appears to be less safe for some, and it is time for the FDA to prioritize safety over simplification.

There is no more important time than now to talk to your physician about any side effects you may be having with Pradaxa. If these adverse events are serious, it may also be time to contact a lawyer.