The US Food and Drug Administration has warned doctors about the increased risk of suicidal thoughts and behaviour connected with a number of treatments used to treat epilepsy and psychiatric disorders.
The agency says it has analysed reports of suicidality from clinical studies of 11 antiepileptics, which include Pfizer’s Lyrica (pregabalin) and Neurontin (gabapentin), Johnson & Johnson’s Topamax (topiramate), GlaxoSmithKline’s Lamictal (lamotrigine), Abbott’s Depakote (valproate) and UCB’s Keppra (levetiracetam).
The FDA says that data from 199 trials involving nearly 43,900 patients revealed that the estimated overall risk of suicidal behaviour was about twice that of the placebo group (0.43% versus 0.22%). Furthermore, that increased risk “was observed at one week after starting the drug and continued to at least 24 weeks”, the agency said, though because most trials included in the analysis did not extend beyond 24 weeks, the risk beyond that “could not be reliably assessed”.
The FDA added that the results were consistent “in all demographic subgroups”, noting that the relative risk for suicidality was higher in the patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions”. The agency concluded by saying that it will be working with drugmakers to include this new information in the labelling for these products and the data will be discussed at an upcoming advisory committee meeting.
All the companies involved have said they look forward to working with the FDA to discuss the labelling on their anti-epileptics.
