How Safe are Off-Label Prescriptions?

Drug Used to Treat Post-Traumatic Stress Disorder for Soldiers May Be Deadly

Medical Malpractice AttorneySeroquel, an anti-psychotic drug approved by the Food and Drug Administration (FDA) to treat schizophrenia, bi-polar disorders, and depression, has been on the market for years. Over the past few years, AstraZeneca, the manufacturer for Seroquel, began marketing this drug to help treat post-traumatic stress disorder (PTSD), insomnia and other conditions not approved by the FDA.

Studies were recently conducted on the side effects of Seoquel. Vanderbuilt University published a study noting that sudden heart failure may be a new side effect. The FDA and AstraZeneca are both reviewing this study to determine its accuracy.

In October of 2009, AstraZeneca paid out $520 million dollars as part of settlement agreements for two federal investigations over clinical trials and off-label promotion, and two whistle-blower lawsuits over aggressive sales and marketing. Details of the federal investigations and whistle-blower lawsuits were not made public. This $520 million barely made a dent in this multi-billion dollar drug, with sales since 2004 totaling over $17 billion.

One of Seroquel’s most recent uses has been for treatment of post-traumatic stress disorder in American soldiers, claiming the drug helps alleviate symptoms of insomnia and restlessness. Thousands of soldiers have been treated for this disorder with Seroquel over the last nine years.

The Associated Press reported on one soldier, Andrew White, who was prescribed the drug after a nine month tour in Iraq after showing signs PTSD. As his nightmares continued his dosages of Seroquel were increased over time, and he was taking more than double the maximum dose prescribed to those using it for schizophrenia.

Not long after started this increased dosage, White died in his sleep. There have been atleast a half-dozen deaths among soldiers taking this drug to treat PTSD, but that number is likely grossly understated.

This story raises a much bigger issue.   Psychiatrists are allowed to prescribe this drug off-label, which means they can prescribe this drug for unapproved indication. Off-label prescriptions tend to be common place in today’s pharmaceutical-driven society, especially since the FDA procedures to approve a drug are costly and time-consuming.

There is generally substantial literature to support off-label usage, which is what doctors will use to determine whether to prescribe these drugs. Doctors have the ability to issue any drug for an unapproved reason, as long as they use their professional judgment to deem it safe and effective for the condition they are prescribing it for.

Isn’t it time that the FDA crack down on the off-label use of drugs as the risks seem to outweigh any potential benefit?

For more information on the Seroquel case, read the Associated Press article:

For more information on Off-Label Prescriptions, read this article by the American College of Physicians:

If you or anyone you know has been adversely affected by using Seroquel, contact Gersowitz Libo & Korek, P.C. at 800-529-9997

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