AstraZeneca's Seroquel on FDA warning list

-Delaware Online

09/06/2008- 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.

A drug's inclusion on the list does not mean the FDA has identified a definite link between the drug and the listed risk. Other drugs the FDA was examining included the anti-depressant Cymbalta, for urinary retention; multiple sclerosis treatment Tysabri, for a potential connection with skin cancer; and the painkiller Oxycontin, for drug abuse and overdose.

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.

"My message to patients is this: Don't stop taking your medicine. If your doctor has prescribed a drug that appears on this list, you should continue taking it unless your doctor advises you differently," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.

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.The Pharmaceutical Research and Manufacturers of America, the main industry lobbying group, said it supports giving more safety information to doctors and patients, but worries that some will be needlessly alarmed.

"Our reservation is that patients will be abruptly stopping therapy," said Alan Goldhammer, a vice president of the organization. "One can't generalize with an emerging safety notice. It may affect half the patients, a quarter of the patients, or only a small subset of the patients."

If you or a loved one have experienced any of the serious Seroquel side effects such as hyperglycemia or diabetes during or after Seroquel treatment, you may be entitled to compensation. Contact the Seroquel attorneys of Ennis & Ennis today for a free confidential case evaluation. Our on staff nurse and lawyers are standing by to answer any questions you may have regarding Seroquel side effects, a possible Seroquel class action lawsuit, or any other type of Seroquel litigation.