Under Pressure, FDA Reveals Deadly Drug Side Effects

The U.S. Food and Drug Administration (FDA) described the risks of several medications in a new report published in its Drug Safety Newsletter for health care professionals.

The move came after the Institute of Medicine (IOM) sharply criticized the FDA in 2006, saying it has “a dysfunctional structure hindering its ability to protect public health.” The Agency has also been criticized for not monitoring drugs after they’re on the market.

The report, which fills one of the FDA’s commitments to the IOM after the criticism, details the side effects from the following drugs:

• Rituxan, a cancer drug that has been liked to a potentially fatal central nervous system disorder.

• Provigil, a narcolepsy drug that has been linked to serious skin reactions.

• Temodar, a brain cancer medicine that has been linked to fatal aplastic anemia.

• Exjade, a blood infusion drug. Reports of kidney failure, 115 deaths, and hospitalizations are suspected to be linked to the drug, although the deaths are now listed as “due to the underlying disease.”

Consumer group Public Citizen said the FDA’s quarterly Drug Safety newsletter could be “a real service” if it focuses on emerging drug side effects .

U.S. FDA Drug Safety Newsletter Fall 2007, Volume 1, Number 1

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