Label Changes for:

Keppra (levetiracetam) Injection for Intravenous Use

May 2008

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- May 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

  • Neuropsychiatric Adverse Reactions
    • Primary Generalized Tonic-Clonic Seizures

ADVERSE REACTIONS

  • Clinical Studies Experience
    • Primary Generalized Tonic-Clonic Seizures (located after Table 4)
  • Table 5
  • Discontinuation Or Dose Reduction In Well-Controlled Clinical Studies
    • Primary Generalized Tonic-Clonic Seizures (located after Table 7)

WARNINGS AND PRECAUTIONS

Neuropsychiatric Adverse Reactions: Primary Generalized Tonic-Clonic Seizures

...As in the partial seizure patients, behavioral symptoms appeared to be associated with Keppra treatment. Gait disorders and somnolence were also described in the study in primary generalized seizures, but with no difference between placebo and Keppra treatment groups and no appreciable discontinuations...

In some patients experiencing primary generalized tonic-clonic seizures, Keppra causes behavioral abnormalities.

In the double-blind, controlled trial in patients with idiopathic generalized epilepsy experiencing primary generalized tonic-clonic seizures, irritability was the most frequently reported psychiatric adverse event occurring in 6.3% of Keppra-treated patients compared to 2.4% of placebo patients...

Non-psychotic mood disorders (reported as anger, apathy, depression, mood altered, mood swings, negativism, suicidal ideation, and tearfulness) occurred in 12.7% of Keppra-treated patients compared to 8.3% of placebo patients...

Label approved 05/16/2008 is not available on Drugs@FDA

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