Contact Us

*    Denotes required field.

   * First Name 

   * Last Name 

   * Email 


Cell Phone 

Street Address 

Zip Code 



Injury Date 

For verification purposes, please answer the below question:

No Yes, I agree to the Parker Waichman LLP disclaimers. Click here to review.

Yes, I would like to receive the Parker Waichman LLP monthly newsletter, InjuryAlert.

please do not fill out the field below.

FDA orders AstraZeneca to change promotions on Seroquel

Nov 28, 2006 |

AstraZeneca Plc. said today it is cooperating with the Food and Drug Administration to address the agency's concern about marketing material the company distributed to physicians regarding Seroquel, its drug for treating schizophrenia and bi-polar disorder.

The FDA's Division of Drug Marketing, Advertising and Communications, in a Nov. 16 letter to AstraZeneca, said the material is "false and misleading" because it minimized the risk of diabetes and did not adequately communicate the risk of neuroleptic malignant syndrome and tardive dyskinesia, a pair of serious muscular conditions.

"We take the letter seriously," said Jim Minnick, an AstraZeneca spokesman. "The safety of the patients who use our medications is our highest priority. We are currently working with the FDA to resolve the matter."

The marketing piece in question is a fact sheet about Seroquel distributed to doctors along with the drug's FDA-approved product label, Minnick said. The company has until Thursday to respond to the FDA's letter.

Seroquel is AstraZeneca's second-biggest selling product with worldwide sales of $2.76 billion in 2005.

Related articles
Parker Waichman Accolades And Reviews Best Lawyers Find Us On Avvo