Epilepsy drugs must carry a new warning about the risk of suicidal thoughts or actions, U.S. officials announced on Tuesday. The new recommendations apply to all antiepileptic medications, including those used to treat psychiatric disorders, migraines, and other conditions.
The companies that make epilepsy drugs must add a warning that the medicines carry a risk of suicidal thoughts or actions. The drug companies must also develop a patient-friendly guide explaining risks, according to the FDA.
The FDA analyzed 199 clinical trials involving 11 anti-epileptic drugs. Regulators found that the risk of suicidal thoughts or behavior was “generally consistent” among all of the drugs and was seen if patients were treated for epilepsy, psychiatric disorders or other conditions.
The FDA’s investigation upon almost 200 studies discovered that 0.43 percent of the patients who were taking the drugs committed suicide or at least had such intentions, compared with 0.24 percent of patients on a placebo. Overall, four people who were taking one of the epilepsy drugs committed suicide, while none of the placebo patients did. Drug manufacturers and examiners argued the findings, saying that it is erroneous to mingle statistics made upon medicines that have different roles.
The list of medications required to add the warning includes: Carbamazepine (marketed as Carbatrol, Equetro, Tegretol XR), Clonazepam (marketed as Klonopin), Clorazepate (marketed as Tranxene), Divalproex sodium (marketed as Depakote, Depakote ER, Depakene), Ethosuximide (marketed as Zarontin), Ethotoin (marketed as Peganone), Felbamate (marketed as Felbatol), Lamotrigine (marketed as Lamictal), Lacosamide (marketed as Vimpat), Topiramate (marketed as Topamax), Trimethadione (marketed as Tridione), Pregabalin (marketed as Lyrica). Beside epilepsy, these drugs are also used for migraines, certain nerve-pain disorders, and psychiatric diseases such as bipolar disorder that also carry a risk of suicide.
GlaxoSmithKline Plc’s Lamictal and Pfizer Inc’s Lyrica are among the top-selling epilepsy drugs. Pfizer spokesman Jack Cox said the company would work with the FDA to update the drug labels for Lyrica and Neurontin. The FDA said it would work with manufacturers of the antiepileptic drugs to include the new information in product labelling.
Transactions of epilepsy medications, regularly prescribed in order to remedy psychiatric disorders, surpassed $10.2 billion in the United States last year. Both Lamictal and Topamax saw roughly $2.1 billion sales, while Lyrica reached nearly $1.1 billion.
“Patients being treated with antiepileptic drugs for any indication should be monitored for the emergence of worsening of depression, suicidal thoughts or behaviour, or any unusual changes in mood or behaviour,” Russell Katz, MD, says in an FDA news release.
On the other hand, the American Epilepsy Society said that the risk of suicide that may be associated with epilepsy medications is extremely low compared to the potential danger of leaving patients with no treatment. The FDA agrees that patients who are currently taking an antiepileptic medicine should not make any treatment changes.
According to FDA data, roughly 11 million patients take the drugs to treat epilepsy, a disease indicated by convulsions that can cause unconscious movement or unintentional actions.
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