New warnings and precautions have been added to the safety label of the anti-epileptic drug Keppra (levetiracetam), alerting patients to possible adverse reactions ranging from psychiatric problems to serious skin reactions.
Keppra is an anti-convulsant medication commonly used to treat patients who suffer from seizures related to epilepsy and other disorders. The medication comes in both brand-name and generic versions and is sold in both tablet and oral solution form.
The new safety labels were approved last month by the Food and Drug Administration (FDA). New warnings on Keppra include the risk for psychiatric symptoms including aggression, agitation, anger, anxiety, apathy, depersonalization, depression, and personality disorder. A total of 13.3 percent of adult Keppra-treated patients and 37.6 percent of pediatric Keppra-treated patients (4 to 16 years of age) reported psychiatric problems compared to 6.2 percent of adults and 18.6 percent of pediatric patients who took a placebo.
Serious dermatological reactions were also reported with the drug, including the devastating disorder Stevens Johnson Syndrome (SJS) and its more serious form, toxic epidermal necrolysis (TEN). The skin reaction is considered an allergic reaction associated with various medications. It can cause the skin to peel off in sheets, leaving the body vulnerable to infections which can be fatal.
Keppra has also been associated with hematologic abnormalities, as well as blood pressure increases in patients aged 1 month to 4 years of age. The medication has also been shown to gradually decrease during pregnancy and become more pronounced during the third trimester. The new safety label advises that pregnant women on Keppra should be closely monitored throughout pregnancy and the postpartum period especially if the dosage was changed during pregnancy.