Safety Alerts & Recalls

What does this mean?

Although the risk of suicidal thoughts and behavior appears to be almost double that of placebo, its frequency remains lower than 1 in 200 - and, and this stage, is unlikely to affect the iGuard risk rating for Oxcarbazepine in otherwise healthy patients.

Since most conditions treated with antiepileptic products are serious in nature, this communication is likely to help doctors and patients watch more closely for suicidal thoughts behavior, especially in patients just starting treatment, but - in most cases - is unlikely to result in changes in treatment. That said, if you are taking any antiepileptic products and have any suicidal thoughts, contact your doctor immediately.

Increased risk of suicidal thoughts and behaviour

The FDA today notified healthcare professionals that a range of anti-epileptic products, including Oxcarbazepine, were associated with a significantly higher risk of suicidal thoughts and behavior (0.43% vs 0.23%) than placebo in clinical trials. This increased risk was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. These results were consistent amongst the eleven drugs studied, and the FDA believes that this risk is likely to be shared by all antiepileptic medications.

For more information, please visit: more information here

Source: FDA
Publication Date: 2008-01-31
Last Updated: 2009-12-06

Visit the medication page for the following drugs:

Share your story Share your story! Tell us how MediGuard has helped you or someone you love. Mobile graphic Download the MediGuard Mobile App to manage your prescription and over-the-counter medications, for free. Registration Info Taking multiple medications puts you at risk for possible drug-drug interactions Registration Info Monitor the medical treatment of you and your loved ones.