The Comparative Safety of Multiple Drug Regimens with Adverse Effects of Risk of Suicidal Ideation or Behavior: A Study Design for Bipolar Disorder

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Bipolar disorder is a relatively rare disease associated with the highest known risk of suicidal ideation or behavior of any disease or disorder. Untreated bipolar disorder is estimated to have a suicide risk of 100 times that of the general population. The disease is challenging to treat for a variety of reasons, particularly the cyclical nature of mood states which may be difficult to detect and impossible to predict, prescription medications that are indicated during some states of the cycle (or episodes) but contraindicated in others, and very limited empirical evidence about the effectiveness of routinely administered multiple drug regimens. A number of prescription drugs routinely used to treat bipolar disorder are labeled for risk of adverse affects of suicidal ideation or behavior by the FDA, but the warnings are so general as to be of limited use to prescribers, patients and families. The greatest potential for new breakthroughs in the treatment of bipolar disorder may come from comparative safety studies using electronic medical records at the population level, but the value of these studies will depend on the quality of observational data, particularly with regard to suicidal ideation and behavior outcomes.


This is a chapter in Frontiers in Suicide Risk: Research, Treatment and Prevention. Edited by Jill E. Lavigne, © 2012 Nova Science Publishers.

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