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Clobazam News
FDA Medwatch Alert: FDA Warns of Rare But Serious Drug Reaction to the Antiseizure Medicines Levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and Clobazam (Onfi, Sympazan)
November 28, 2023 – FDA Warns of Rare But Serious Drug Reaction to the Antiseizure Medicines Levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and Clobazam (Onfi, Sympazan) What safety...
Study Looks at Links Between Anxiety Disorders, Benzodiazepines, Dementia
MONDAY, Aug. 14, 2023 – Benzodiazepines and anxiety disorders are associated with dementia risk, but for patients with anxiety disorders, no additional risk is seen with benzodiazepine use,...
FDA Medwatch Alert: Drug Safety Communication: Benzodiazepine Drug Class - Boxed Warning Updated to Improve Safe Use
ISSUE: The FDA is requiring the Boxed Warning, FDA’s most prominent warning, be updated by adding other information to the prescribing information for all benzodiazepine medicines. This information w...
FDA Approves Sympazan (clobazam) Oral Film for Adjunctive Treatment of Seizures Associated with Lennox-Gastaut Syndrome
WARREN, N.J., Nov. 2, 2018 /PRNewswire/ – Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved...
FDA Approves Diacomit (stiripentol) for Seizures Associated with Dravet Syndrome
On August 20, 2018, the U.S. Food and Drug Administration (FDA) approved Diacomit (stiripentol) for seizures associated with Dravet syndrome in patients 2 years of age and older taking clobazam. ...
FDA Medwatch Alert: Opioid Pain or Cough Medicines Combined With Benzodiazepines: Drug Safety Communication - FDA Requiring New Boxed Warnings About Serious Risks and Death
ISSUE: FDA review has found that the growing combined use of opioid medicines with benzodiazepines or other drugs that depress the central nervous system (CNS) has resulted in serious side effects,...
FDA Medwatch Alert: Onfi (clobazam): Drug Safety Communication - Risk of Serious Skin Reactions
ISSUE: FDA is warning the public that the anti-seizure drug Onfi (clobazam) can cause rare but serious skin reactions that can result in permanent harm and death. FDA approved changes to the Onfi...
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Lennox-Gastaut Syndrome, Seizures, Epilepsy