Friday, March 9, 2012

FDA acts with reckless abandon denying AstraZeneca's Citizen Petition regarding generic Seroquel labeling

FDA responds to AstraZeneca Citizen Petitions on quetiapine product labelling

Friday, 9 March 2012
AstraZeneca today announced that on 7 March 2012, the FDA denied Citizen Petitions requesting that the FDA withhold finally approving any generic quetiapine product with labelling that omits certain hyperglycaemia warning language that the FDA required AstraZeneca to include in the labelling for SEROQUEL® (quetiapine fumarate) and SEROQUEL XR® (quetiapine fumarate).

The U.S. FDA acts with reckless endangerment when it omits ANY drug side effect warnings from the label of the antipsychotic Seroquel (quetiapine). The antipsychotic is being prescribed for off-label use for insomnia, anxiety, for PTSD, to war veterans, to children--and the FDA which could act as a gatekeeper for drug safety---continues to promote the use of this dangerous product by actions like this. The fact that the drug made its way to the market place with a background of buried data and internal documents that show AstraZeneca's intent to market the drug anyway should be enough to pull this drug from sales. Instead it receives numerous and seemingly endless indications and now is on its way to generic version. The off-label prescribing will only increase with that version available! 
AstraZeneca's Citizen Petition appears to be one of serving the public, but make no mistake that was a move to keep this drug non-generic as long as possible for $$$ The major drug company with over 26,000 lawsuits for diabetes (which still is being ironed out, as the plaintiffs have not received settlements yet) suddenly wants to display all hyperglycemia related labeling on generics? 
Why didn't AstraZeneca display that on the product label from the beginning? The company buried Study 15, skewed data and KNEW the drug could cause weight gain and diabetes! NOW they want to be treated equally? If the generic drug doesn't have all the warning labels we were required to have then let's complain to the FDA? I smell $$$$$$$! 

This news on the heels of a commentary published in the Australian & New Zealand Journal of Psychiatry

Quetiapine-related harms are on the rise

  1. Cherie E Heilbronn1
  2. Belinda Lloyd1
  3. Paul McElwee1
  4. Alan Eade2
  5. Dan I Lubman1
  1. 1Turning Point Alcohol and Drug Centre, Eastern Health and Monash University, Victoria, Australia
  2. 2Ambulance Victoria, Victoria, Australia
  1. Belinda Lloyd, Turning Point Alcohol and Drug Centre, 54−62 Gertrude Street, Fitzroy, VIC 3065, Australia. Email:
To the Editor
In the December 2010 issue, Hollingworth et al. (2010) detailed increased prescribing of atypical antipsychotic medications in Australia between 2002 and 2007. While olanzapine and risperidone remain the most commonly prescribed atypical antipsychotics, quetiapine prescribing is increasing, with PBS prescriptions rising by 27% between 2008/09 (431,096) and 2009/10 (545,410) (Department of Health and Ageing, 2010). Reasons for the growing use (including off-label prescribing) relate to its sedative properties and favourable extrapyramidal and metabolic profile, as well as emerging evidence of positive outcomes at low doses for a range of mental disorders (Hollingworth et al., 2010).
While the toxicity profile of atypical antipsychotics is considered preferable to typical agents, particularly regarding overdose risk, recent literature has called the relative safety of quetiapine into question. In one study, quetiapine-related overdoses were more likely to result in hypotension, respiratory depression, coma, or death than all the other antipsychotics combined (Ngo et al., 2008). This is particularly concerning given the growing number of case reports citing quetiapine as a potential substance of misuse, a phenomenon unseen with other atypical antipsychotic preparations (Sansone and Sansone, 2010).
A recent study (Lloyd and McElwee, 2011) identified a non-significant increase in antipsychotic-related ambulance attendances over 2000−2009 in metropolitan Melbourne. While demographic characteristics remained relatively consistent over the period, there was a significant increase in antipsychotic-related attendances where other drugs (both licit and illicit) were also implicated in presentations. However, differential harms across different antipsychotic preparations have not been adequately explored at a community level.
To further our understanding of this emerging issue, we analysed ambulance attendance data from metropolitan Melbourne across different antipsychotic preparations to provide a preliminary quantification of quetiapine-related harms. Data were derived from the Ambo Project database (Lloyd and McElwee, 2011), utilizing data from patient care records completed by paramedics, with additional coding undertaken to identify involvement of alcohol or other drugs in ambulance presentations. While there was a small increase in antipsychotic-related ambulance attendances between 2000/01 and 2009/10 (from 783 to 1074 attendances), quetiapine-related attendances increased substantially over the same period (from 32 in 2000/01 to 598 in 2009/10). Similar increases were not found for other antipsychotic preparations.
Anecdotal reports from Victorian alcohol and drug agencies participating in the Earlier Identification of Drug Harms Project (unpublished data) indicate that quetiapine demand, use, diversion, misuse, and harms are ongoing issues, particularly for clients with a history of illicit drug use. Over the course of this project involving bi-monthly data collection, quetiapine was the only antipsychotic consistently reported as being used in a problematic manner, regardless of source of supply.
Such an increase in acute quetiapine-related harm represents a growing public health issue. Further exploration is required to identify the nature and magnitude of quetiapine-related harms, population groups at increased risk of harm, prescribing trends, and strategies to ensure benefits of quetiapine are balanced against potential risks to patients, and costs to the community. In the meantime, it is important that clinicians are aware of growing misuse and diversion of quetiapine, and adopt prescribing practices that minimize the risk of harms.


This project is a collaborative project between Turning Point Alcohol and Drug Centre and Ambulance Victoria, and is funded by the Victorian Department of Health.


The authors would like to acknowledge and kindly thank Ambulance Victoria and its paramedics for their entry of data used in this study and Annie Haines for coding cases.

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