The US Food and Drug Administration (FDA) issued a health alert on 31 January 2008, to provide new information to health care professionals to let them know there is an increased risk of suicidal thoughts and behaviours in patients who take drugs called antiepileptics - these drugs are used to treat epilepsy, bipolar disorder, migraine headaches, and other conditions.
The FDA have analysed reports from the controlled studies of 11 anti-epileptic drugs and have determined that the patients who took these drugs were at twice the risk of suicidal thoughts and behaviours (suicidality) compared to the placebo group (who took no drugs). This risk means that 2.1% more patients per 1,000, who take the antiepileptics are at increased risk for suicidality.
The analysis of the data from the reports, included 27,863 patients in drug treatment groups and 16,029 patients in placebo groups. Four patients in the drug treatment groups attempted suicide and none in the placebo groups. There were 105 reports of suicidal thoughts or behaviour in the drug-treated patients and only 35 in the placebo-treated patients.
The higher risk of suicidal thoughts and behaviours started around one week after drug treatment and continued on through the drug treatment. All the different antiepileptic drugs had the same risk of suicidal thoughts and behaviours in the drug-treated patients, across all age groups.
"We want health care professionals to have the most up to date drug safety information," said Russell Katz, M.D., director of the Division of Neurology Products in FDA's Centre for Drug Evaluation and Research. "This is an example of FDA working with drug manufacturers throughout products' lifecycles to keep health care professionals informed of new safety data."
The FDA warns that patients who are currently taking antiepileptic drugs, should not stop taking their medicine, but should talk to their doctor about their concerns. In addition, the FDA also advises that health care providers should discuss the risks and benefits of the antiepileptic drugs with their patients and their families, given this new information.
Antiepileptic drugs in the analyses included the following:
Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
Felbamate (marketed as Felbatol)
Gabapentin (marketed as Neurontin)
Lamotrigine (marketed as Lamictal)
Levetiracetam (marketed as Keppra)
Oxcarbazepine (marketed as Trileptal)
Pregabalin (marketed as Lyrica)
Tiagabine (marketed as Gabitril)
Topiramate (marketed as Topamax)
Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
Zonisamide (marketed as Zonegran)
Some of these drugs are also available in generic form.
The drugs listed above were the only ones used in the studies, but the FDA believes that all types of anti-epileptics, even if they are not on the list above, also increase the risk of suicidality.
FDA Health Alert
FDA Alerts Health Care Providers to Risk of Suicidal Thoughts and Behavior with Anti-Epileptic Medications (31 January 2008)
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