Thursday, September 11, 2008

FDA Investigating Antipsychotic Seroquel for Safety Problems

REFRESH - Go to Home-Page

Seroquel is one of the newer "atypical" antipsychotics that are costing State medicaid programs dearly. Others include Abilify, Geodon, Risperdal and Zyprexa.
Example: Florida Medicaid paid the below on kids only, 18 and under, for the last 5 years. Geodon, Seoquel and Zyprexa have ZERO FDA approved uses for children.
How much is your State Medicaid program paying for these drugs on kids?

Perhaps your state legislators (and newspapers) would like to know.

Abilify 2003 $1,539,509.55
Abilify 2004 $5,359,775.43
Abilify 2005 $8,579,480.93
Abilify 2006 $10,090,910.44
Abilify 2007 $10,271,082.29

Geodon 2003 $904,035.19
Geodon 2004 $1,187,428.90
Geodon 2005 $1,189,068.28
Geodon 2006 $1,484,866.82
Geodon 2007 $1,722,867.61

Risperdal 2003 $8,301,415.13
Risperdal 2004 $8,928,425.18
Risperdal 2005 $8,855,072.01
Risperdal 2006 $8,868,847.84
Risperdal 2007 $9,509,060.26

Seroquel 2003 $3,911,146.00
Seroquel 2004 $5,608,500.30
Seroquel 2005 $6,690,734.14
Seroquel 2006 $7,414,643.93
Seroquel 2007 $7,843,666.17

Zyprexa 2003 $5,850,078.39
Zyprexa 2004 $4,667,326.50
Zyprexa 2005 $2,312,692.06
Zyprexa 2006 $1,892,506.73
Zyprexa 2007 $1,992,219.54

The News Journal
AstraZeneca's Seroquel on FDA warning list

September 6, 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...

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.

Story link:

Thanks for this story

No comments: