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Jack Sisson's Life Ethics Blog
We must find new ways through many ethical issues, especially regarding bioethics, medical ethics, and criminal justice. Jack Sisson's 'Life Ethics' blog focuses on numerous areas of concern, including the philosophical and ethical dilemmas surrounding stem-cell research, abortion, medical research, and health care.
Sunday, April 08, 2012
PRADAXA A POTENTIALLY DANGEROUS DRUG, ACCORDING TO FDA
From Clark, Purdue and List Company, LPA -- a Personal Injury Law Blog
Pradaxa, also known as dabigatran, is being investigated by the Food and Drug Association as potentially dangerous drug. Pradaxa is a prescription medication used as a blood thinner, and is manufactured and sold by Boehringer Ingelheim. Pradaxa was approved by the Food and Drug Administration in October 2010. Since it was approved by the FDA, approximately 1.1 million prescriptions for Pradaxa have been written.
Pradaxa was the first in a new class of medications called "direct thrombin inhibitors." Pradaxa was intended to be used to prevent strokes in people with atrial fibrillation and was designed to replace warfain as a blood thinner. While excessive bleeding caused by warfarin can be counteracted with vitamin K, there is no antidote for excessive bleeding caused by Pradaxa.
Recently, Pradaxa has been implicated in 260 reports of fatal bleeding worldwide. The death of an elderly man from a massive brain hemorrhage following a routine fall indicates that bleeding complications from Pradaxa are irreversible. This death spurred the FDA to issue a Drug Safety Communication reporting the initiation of a safety investigation into reports of serious bleeding. According to doctors from the University of Utah, an 83 year old man was seen at a medical center after a routine fall. Initially, he was fully alert and oriented and his neurological exam did not raise concern. However, within 2 hours, additional CT scans revealed extensive brain hemorrhage. All efforts to stop the hemorrhaging failed and the man went into a coma and died shortly thereafter.
In October 2011, the Institute for Safe Medication Practices released a report stating that Pradaxa was named in more FDA adverse event reports than over 98% of medications monitored by that group. Patients with impaired renal function are particularly susceptible to adverse side effects from Pradaxa because their kidneys are unable to flush all of the drug from the body resulting in an excessively amount of Pradaxa in the system.
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