FDA orders AstraZeneca to change promotions on SeroquelNov 28, 2006 | www.delawareonline.com 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.