FDA Asks AstraZeneca To Warn Of Weight Gain On Seroquel

Yesterday, the Bloomberg wire service reported that the FDA recently wrote to AstraZeneca, makers of Seroquel, and ordered the company to update its labeling for the drug to include a warning of "significant weight gain" due to use of the drug. This news came out not because the FDA suddenly made its request of AZ public, but because of documents that became public in a court case in Florida where AZ is being sued over various accusations about its handling of the drug, a $4 billion-plus seller in 2007.

I've asked the FDA to provide me with a copy of the letter it sent AZ, but so far nothing but the agency's usual silence.

The issue of weight gain is crucial because rapid and significant weight gain can lead to diabetes and a host of other maladies. It's not clear to me what data the FDA has that prompted the label change and it's not clear what kind of weight gain was being experienced by patients. I took this drug for about 14 months and saw an approximate weight gain of 10 percent of my body weight. When I began taking Seroquel in 2004 there was no warning on its label for weight gain, which kind of makes me roll my eyes at what the company told Bloomberg.

"Seroquel’s label has 'always provided accurate and appropriate information and warnings,' Tony Jewell, a spokesman for AstraZeneca in Wilmington, Delaware, said in an e-mailed statement. 'We continue to work with the FDA to share accurate information with the public as more scientific data becomes available about the medicine.'"

I have reviewed the current package insert (pdf here) for Seroquel and cannot find where it reflects the FDA's order. As far as I am concerned, AZ is not providing "accurate and appropriate information and warning."

The court case is scheduled to begin Feb. 2.