The FDA today notified healthcare professionals that a range ofanti-epileptic products, including DEPAKOTE ER, were associatedwith a significantly higher risk of suicidal thoughts andbehavior (0.43% vs 0.23%) than placebo in clinical trials. Thisincreased risk was observed as early as one week after startingthe antiepileptic drug and continued through 24 weeks. Theseresults were consistent amongst the eleven drugs studied, andthe FDA believes that this risk is likely to be shared by allantiepileptic medications.
For more information, please visit :http://www.fda.gov/medwatch/safety/2008/safety08.htm#Antiepileptic
* * * *WHAT DOES THIS MEAN?
Although the risk of suicidal thoughts and behavior appears tobe almost double that of placebo, its frequency remains lowerthan 1 in 200 - and, and this stage, is unlikely to affect theiGuard risk rating for DEPAKOTE ER in otherwise healthypatients.
Since most conditions treated with antiepileptic products areserious in nature, this communication is likely to help doctorsand patients watch more closely for suicidal thoughts behavior,especially in patients just starting treatment, but - in mostcases - is unlikely to result in changes in treatment. Thatsaid, if you are taking any antiepileptic products and have anysuicidal thoughts, contact your doctor immediately.
For updated risk ratings on all of your registered medications,or to update your medication list, please log into your profile(https://secure.iGuard.org/user). You can also reach yourprofile by clicking on the link in the top right corner of anypage on our web site.
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==============================DISCLAIMER
iGuard is not intended to be a substitute for professionalmedical advice. iGuard cannot and does not take intoconsideration every possible interaction or account forindividual responses to medicine. Different individuals mayrespond to medication in different ways. The absence of awarning for a given drug or drug combination in no way should beconstrued to indicate that the drug or drug combination is safe,effective, or appropriate for any given patient. Always seek theadvice of a qualified health provider with any questions you mayhave before making any changes to your treatment. The use of theiGuard site and its content is at your own risk. (c) 2007iGuard.org. All rights reserved. iGuard.org, 66 Witherspoon St#262, Princeton, NJ 08542.
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