Daily Archives: September 6, 2008

AstraZeneca’s Seroquel on FDA warning list

The News Journal

AstraZeneca’s antipsychotic drug Seroquel is one of 20 medications being investigated for potential safety problems, federal regulators said Friday.

The list of drugs posted by the U.S. Food and Drug Administration under the requirements of a new law offered little information except for the potential risks the agency was examining.

Seroquel was being looked at for “overdose due to sample pack labeling confusion,” presumably referring to label information on the free drug samples AstraZeneca distributes to doctors and hospitals. Neither the FDA nor the drug maker would elaborate on the potential risk.

“We know that FDA has received reports regarding the label on sample packs for Seroquel, and we are working closely with the FDA to determine the nature of these reports,” said AstraZeneca spokeswoman Abby Baron. An FDA spokesman did not respond to questions on the Seroquel reports.

The FDA compiled its list from “adverse event” reports it receives from drug makers, doctors and patients. For a medication to be listed, the FDA said, an agency reviewer has determined that the drug merits a closer look because of the number or seriousness of the complaints…

FDA officials said they are trying to walk a fine line in being more open to the public while avoiding needless scares. Congress, in a drug safety bill passed last year, ordered the agency to post quarterly listings of medications under investigation…

The FDA’s list received a mixed reaction from some consumer advocates who said more information was needed about the potential risks.

“It’s a good thing to get started but it needs to have much more detail if it’s to have significant safety value,” said Thomas J. Moore, a senior scientist with the Institute for Safe Medication Practices.


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