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Using the law as a warning
The Food and Drug Administration is now requiring the drug Phenergan to don a strict warning label, the New York Times reported on Saturday.
The drug, also known as promethazine, was a subject of a Supreme Court case after a Vermont musician had to have her hand and forearm amputated after an accidental dose that made her limbs gangrenous.
Phenergan is an anti-nausea drug that, before now, carried a mild warning for doctors to watch out for gangrene.
The big hooplah that concerns this case especially is the fact that the Obama administration's FDA decision is a direct 180 away from the types of decisions made by the Bush administration concerning drug label warnings.
Stated the newspaper, "the change suggests that the Obama administration may view lawsuits as helpful to its work, a position that had been the policy of the drug agency before the Bush administration."
This could mean that law could be another factor in determining best practices, along with evidence-based medicine and peer reviewed trials and studies.
To read the full article, click here: http://www.nytimes.com/2009/09/19/health/19drug.html?_r=1&scp=7&sq=September+19+2009&st=nyt


