Tuesday, February 14, 2006

The FDA and Safety

So many Americans look to FDA approval as some sort of guarantee of safety. I suppose it does limit the sales of snake oil, but beyond that, how can anyone trust them implicitely? Here is a recent report on Ritalin (emphasis added):

Ritalin and other stimulants that are prescribed to treat attention deficit hyperactivity disorder (ADHD) should carry the most serious type of warning labels, US experts recommended Thursday.
The Food and Drug Administration committee narrowly voted to call for adding "black box" safety warnings to ADHD drugs. Black-box warnings are intended to alert physicians and patients that a drug may carry significant risks.
There have been 51 deaths among children and adults taking drugs for ADHD in the US since 1999. Other reports described high blood pressure, chest pain, heart attacks, strokes, irregular heart beats and fainting.
"The data is only suggestive at this point, but because of the gravity of the side effect, namely sudden death, physicians need to be made clearly aware of that concern," said Dr. Peter Gross, the panel chairman and head of internal medicine at Hackensack University Medical Center in New Jersey.

So, in light of this, they are going to issue a warning? And it was a close vote? How many needed to die for them all to be in favor of a warning?

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