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Pradaxa – Suspected in More Suspect Cases Than Any Other FDA Monitored Drug

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The number of deaths and life-altering side effects associated with Pradaxa continue to rise. Pradaxa is a prescription blood-thinning medicine used to reduce the risk of stroke and blood clots in people with atrial fibrillation.

Although it has only been on the market for a year and a half, Pradaxa was listed as a suspect drug in 856 reported cases from the second quarter of 2011. This number is higher than all other regularly monitored drugs. Of the reported cases from this quarter, 117 were reported patient deaths.

QuarterWatch, an independent publication of the Institute for Safe Medication that monitors all domestic, serious adverse drug events reported to the FDA reiterated their concerns that:

“Vulnerable older patients may be receiving an overdose of this one-size-fits-all drug.”

Pradaxa’s instructions do not require routine kidney function testing, or blood level tests. Lower dosage options to tailor prescriptions to individuals’ needs are not available. QuarterWatch points to these factors as some of the causes of overdoes and hemorrhages in the oldest patients on Pradaxa.

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    I don’t mean to point any fingers, but what’s the FDA’s response on this?