FDA Requests Additional Information about Expanded Seroquel Use
December 29th, 2008 • Filed Under: News • 3 Comments
AstraZeneca released a statement last week indicating that the FDA has requested additional information about their antipsychotic medication Seroquel, which the drug maker is attempting to obtain expanded approval to market as a once-daily treatment of depression in adults.
Seroquel (quetiapine fumarate) was originally approved by the FDA in 1997 as a twice-daily treatment for schizophrenia, but has been widely used off-label for years for other uses.
In October 2008, Seroquel XR, extended release tablets, were approved as a once-daily treatment for mania, depressive and mixed episodes in bipolar disorder, and as maintenance treatment of bipolar disorder with lithium or divalproex.
Seroquel is the second best selling drug for AstraZeneca, with annual sales of over $4 billion.
The FDA requested additional information about Seroquel XR in a Complete Response Letter, as part of their review of a supplemental new drug application filed by AstraZeneca seeking approval for use of the drug by people suffering from major depressive disorders.
The contents of the FDA communication have not been disclosed, but AstraZeneca indicates that they are reviewing the Complete Response Letter and proposed labeling revisions.
Seroquel side effects have been linked to an increased risk of weight gain, diabetes, hyperglycemia and pancreatitis, and the drug maker currently faces Seroquel lawsuits from over 13,000 people who allege they failed to previously provide adequate warnings about the risks.
The first trial in the Seroquel litigation is scheduled to begin in February 2009, and during pretrial motions earlier this month, an internal document was released which suggested that AstraZeneca was aware of the Seroquel diabetes side effects as early as 2000, yet failed to warn users of the risks for several years.
AstraZeneca indicates that they will provide a response to the FDA in due course. However, the drug maker stressed that the FDA Complete Response Letter does not change the current recommendations for individuals taking Seroquel or Seroquel XR for approved uses, such as schizophrenia or bipolar disorder.
Comment by jill on 3 January 2009:
i was put on seroquel severalyears ago and withi months i blew up like a ballon. i am jist under 5 ft. tall and fluctuat between 125 and140 lbs. this deoends on how much i can push myself to excercise when i am very fatigued all the time. also i have had numerous bouts of painful pancreatitis. now i can’t even have 1 alcoholic drink as that could be enogh to make me sick. now i know the reason for the pancreatitis which i never had befor seroquel. because most of my weight is in my belly i’m scared becouse it;s a bad place to have it,
Comment by kc on 19 January 2009:
i was prescribed seroquel to help me sleep. most other medications did not work and serquel put me out in 5 min. it was fine at first until i started to wake up in the middle of the nite and see things. i quickly got off it out of fear it was actually making me psycho. now i take ambien, have trouble sleeping but feel much better not being on it!
Comment by kc on 19 January 2009:
p.s. i dont know of any complications so far. I am only 26 so i am scared as i took it for 3 years.