Healthy Skepticism Library item: 7178

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

AstraZeneca working with FDA after drug warning
Forbes.com 2006 Nov 27
http://today.reuters.com/news/articleinvesting.aspx?type=governmentFilingsNews&storyID=2006-11-27T101823Z_01_L27846635_RTRIDST_0_ASTRAZENECA-SEROQUEL.XML

Abstract:

AstraZeneca Plc said on Monday it would work with the U.S. Food and Drug Administration to resolve a problem over promotional material for its drug Seroquel after receiving a warning from the agency.

A letter received from the FDA earlier this month stated that sales material for the company’s second biggest-selling product was “false or misleading” because it minimised the risk of hyperglycemia and diabetes and failed to communicate important information regarding neuroleptic malignant syndrome.

Seroquel, which had global sales of $2.76 billion last year, is indicated for the treatment of schizophrenia and bipolar disorder.

AstraZeneca said it did not intend the promotional material to mislead and noted it was distributed with a copy of the FDA-approved product labeling, which included the complete warnings and precautions.

“AstraZeneca takes the FDA’s letter seriously. We will work with the FDA to resolve the matter,” the group said.

Seroquel belongs to a class of drugs called atypical antipsychotics and is the most-prescribed treatment of its type in the United States.