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Details:
FDA ALERT:
The FDA has analyzed reports of suicidality (suicidal behavior or ideation)
from placebo-controlled clinical studies of eleven drugs used to treat epilepsy
as well as psychiatric disorders, and other conditions. These drugs are commonly
referred to as antiepileptic drugs (see the list below). In the FDA’s analysis,
patients receiving antiepileptic drugs had approximately twice the risk of
suicidal behavior or ideation (0.43%) compared to patients receiving placebo
(0.22%). The increased risk of suicidal behavior and suicidal ideation was
observed as early as one week after starting the antiepileptic drug and
continued through 24 weeks. The results were generally consistent among the
eleven drugs. Patients who were treated for epilepsy, psychiatric disorders, and
other conditions were all at increased risk for suicidality when compared to
placebo, and there did not appear to be a specific demographic subgroup of
patients to which the increased risk could be attributed. 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.
All patients who are currently taking or starting on any antiepileptic drug
should be closely monitored for notable changes in behavior that could indicate
the emergence or worsening of suicidal thoughts or behavior or depression.
This information reflects FDA’s current analysis of available data concerning
these drugs. Posting this information does not mean that FDA has concluded there
is a causal relationship between the drug products and the emerging safety
issue. Nor does it mean that FDA is advising health care professionals to
discontinue prescribing these products. FDA intends to update this document when
additional information or analyses become available.
Information for patients, family members, and caregivers:
• Taking antiepileptic medicines may increase the risk of having suicidal
thoughts or actions;
• Do not make any changes to the medication regimen without first talking with
the responsible healthcare professional;
• Pay close attention to any day-to-day changes in mood, behavior and actions.
These changes can happen very quickly so it is important to be mindful of any
sudden differences.
• Be aware of common warning signs that might be a signal for risk of suicide.
Some of these are:
o Talking or thinking about wanting to hurt yourself or end your life
o Withdrawing from friends and family
o Becoming depressed or having your depression get worse
o Becoming preoccupied with death and dying
o Giving away prized possessions
If these or any new and worrisome behaviors occur, contact the responsible
healthcare professional immediately.
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