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 Topiramate 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 and 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 Topiramate, 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.
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