FDA: Antiepileptics Linked to Increased Risk of Suicidal Thoughts, Behavior

-DG News

12/17/2008- ROCKVILLE, Maryland -- The US Food and Drug Administration has announced today that it will require the manufacturers of antiepileptic drugs to add to these products' prescribing information, or labeling, a warning that their use increases risk of suicidal thoughts and behaviors. The action includes all antiepileptic drugs including those used to treat psychiatric disorders, migraine headaches, and other conditions, as well as epilepsy.

The FDA is also requiring that the manufacturers submit for each of these products a Risk Evaluation and Mitigation Strategy, including a Medication Guide for patients. The guides will contain FDA-approved information about the risks of suicidal thoughts and behaviors associated with the class of antiepileptic medications.

"Patients being treated with antiepileptic drugs for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior," said Russell Katz, MD, Division of Neurology Products, FDA's Center for Drug Evaluation and Research, Rockville, Maryland. "Patients who are currently taking an antiepileptic medicine should not make any treatment changes without talking to their health care professional."

Healthcare professionals should notify patients, their families, and caregivers of the potential for an increase in the risk of suicidal thoughts or behaviors so that patients may be closely observed.

The FDA's actions are based on the agency's review of 199 clinical trials of 11 antiepileptic drugs which showed that patients receiving antiepileptic drugs had almost twice the risk of suicidal behavior or thoughts (0.43%) compared with patients receiving a placebo (0.24%). This difference was about 1 additional case of suicidal thoughts or behaviors for every 500 patients treated with antiepileptic drugs instead of placebo.

Of the patients who were randomized to receive one of the antiepileptic drugs, 4 committed suicide, whereas none of the patients in the placebo group did. Results were insufficient for any conclusion to be drawn about the drugs' effects on completed suicides.

The biological reasons for the increase in the risk for suicidal thoughts and behavior observed in patients being treated with antiepileptic drugs are unknown.

Acting under the authorities of the Food and Drug Administration Amendments Act of 2007 (FDAAA), the FDA is requiring manufacturers of antiepileptic drugs to submit to the agency new labeling within 30 days, or provide a reason why they do not believe such labeling changes are necessary. In cases of non-compliance, FDAAA provides strict timelines for resolving the issue and allows the agency to initiate an enforcement action if necessary.

The following antiepileptic drugs are required to add warnings about the risk of suicidality: carbamazepine (Carbatrol, Equetro, Tegretol, Tegretol XR); clonazepam (Klonopin); clorazepate (Tranxene); divalproex sodium (Depakote, Depakote ER, Depakene); ethosuximide (Zarontin); ethotoin (Peganone); felbamate (Felbatol); gabapentin (Neurontin); lamotrigine (Lamictal); lacosamide (Vimpat); levetiracetam (Keppra); mephenytoin (Mesantoin); methosuximide (Celontin); oxcarbazepine (Trileptal); phenytoin (Dilantin Suspension); pregabalin (Lyrica); primidone (Mysoline); tiagabine (Gabitril); topiramate (Topamax); trimethadione (Tridione); and zonisamide (Zonegran). Some of these medications are also available as generics.

Health care professionals and consumers may report serious adverse events or product quality problems with the use of these products to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

-- Online : www.fda.gov/MedWatch/report.htm

-- Regular Mail : use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787

-- Fax: (800) FDA-0178

-- Phone: (800) FDA-1088

SOURCE: US Food and Drug Administration

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