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Pradaxa findings call the FDA's review process into question

Pharmaceutical drug and medical device approval by the Food and Drug Administration (FDA) is really the only standard by which patients can hope to secure safe treatment for their illnesses and health conditions. If the FDA approves a drug or medical device, patients and physicians alike often assume that the approved item is safe, save for any side effects or warnings listed on the packaging.

However, a recent scandal involving the bloodthinner Pradaxa has many safety advocates, healthcare professionals and patients questioning whether the standards that the FDA uses to determine the approval or rejection of a given drug or device are actually more helpful than harmful.

In essence, the FDA recently conducted an extensive investigation into potentially fatal hemorrhaging associated with Pradaxa. It ultimately determined that because Pradaxa is no more likely to induce hemorrhaging than the traditional anti-clotting drug Warfarin, it is safe to remain on the marketplace.

However, Pradaxa has one defining characteristic that Warfarin does not. Praxada has no antidote and therefore if its anti-clotting properties spiral out of control, there are virtually no ways to save patients from bleeding out.

This scenario has individuals all over the country asking why the FDA's standard of hemorrhage-inducement is being highlighted as a reason to continue approving the drug for patient use, even though the hemorrhages use does induce make it virtually impossible for patients to survive them.

The manufacturers of Pradaxa are being sued in more than 150 lawsuits currently, tied to the more than 500 patients who have died as a result of complications from the drug and untold numbers of injured patients. The Pradaxa saga is far from over, both for its manufacturer and for the FDA, which should set about immediately to alter its approval criteria for potentially fatal drugs.

Source: Forbes, "Was The FDA Safety Analysis For A Popular Bloodthinner Flawed?" Ed Silverman, Nov. 6, 2012

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