Mental Health Blogs

Next month, the FDA’s psychopharmacology advisory committee takes up AstraZeneca’s application to have its atypical antipsychotic Seroquel approved for the treatment of schizophrenia in kids aged 13 to 17 and for use in so-called pediatric bipolar disorder in kids aged 10 to 17. Seroquel is not currently approved for use in pediatric populations for any indication. The committee will make a recommendation to the FDA on whether to approve or not approve the drug for these disorders, but the agency is not bound by its recommendation.

AZ’s submission to the FDA has not been made public yet, so it’s not clear what kind of safety and efficacy data the committee will see, but from the recently-released Seroquel documents (all lawsuit-related) it is clear that the drug caused multiple cases of glucose dysregulation and potentially diabetes in some kids under the age of 18 who were given Seroquel off-label. There have also been reported cases of deaths in this population associated with use of Seroquel.

These details come from the following document dated Dec. 14, 2004 which is entitled “Review of all pediatric reports for Seroquel through 30 September 2004.” It is an internal company document, labeled confidential and likely created in response to FDA queries. The document is sizable (13.8 MBs) and I respectfully request that you only download it if you have a serious research or journalistic need for it, as I do have bandwidth limits on this site.

On page 135 of the report, 27 cases of glucose dysregulation are identified with the majority of the reports involving patients aged 12 to 18. Several of these cases resolved into diabetes mellitus. How connected that is with Seroquel use is unclear, but what is clear is that the report identifies several cases of successful dechallenges–take away the Seroquel and away goes the glucose problem–and that’s a clear indication of some kind of link between drug use and condition, at least in some of the patients.

Several of these children were being given Seroquel for pediatric bipolar disorder, conduct disorder, Asperger’s and, in one case, ADHD. That’s exactly the type of patient population that the advisory committee will be reviewing safety and efficacy data about in June and one hopes they pay attention to any glucose dysregulation data presented to them by the FDA and AZ. But there’s only one problem: that data is almost certain to come from short-term clinical trials and glucose dysregulation doesn’t usually happen immediately. So one hopes that members of the committee somehow gain access to the report I’ve made available above.

For itself, the AZ report notes that the company did not consider any of the data in the report to contain indications of safety problems in pediatric populations.

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Related posts:

1. FDA Dubs Antipsychotics For Kids Effective With Substantial Risks
2. Seroquel Documents: Criminals Led Seroquel Clinical Trials
3. Perspective On Antipsychotics For Kids FDA Panel Recommendation
4. Study: Medicaid Kids Get Antipsychotics At Four Times The Rate Of Privately-Insured Kids
5. Is Seroquel Litigation Going Down The Toilet?