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Home / Uncategorized / FDA Warns of Serious Skin Reactions with...

FDA Warns of Serious Skin Reactions with Anti-Seizure Drug Onfi

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In a recent Safety Announcement, the U.S. Food and Drug Administraion (FDA) warned the public that the anti-seizure drug Onfi (clobazam) may cause rare sskin reaction that can result in permanent harm and in some cases, death.

Changes to the Onfi drug label have been approved and the patient Medication Guide now describes the risk of these serious skin reactions.  The FDA suggests that patients taking Onfo seek immediate medical treatment if they develop any combination of the following symptoms:

  • Rash
  • Blistering
  • Peeling of the skin
  • Sores in the mouth
  • Hives

The FDA also recommends that health care professionals discontinue use of Onfi and consider an alternate therapy at the first sign of rash, unless it is clearly unrelated to the drug.

Stevens-Johnson symdrome (SJS) and toxic epidermal necrolysis (TEN), the serious skin reaction caused by Onfi, can occur at any time during Onfi treatment.  However, the greatest risk of skin reactions takes place during the first eight weeks of treatment.  There is also great risk when Onfi is sopped and then re-started.  All cases of SJS and TEN in the FDA case series have resulted in hospitalization.  One case resulted in blindness, and one in death.

Onfi is a benzodiazepine medication used in combination with other medicines to treat seizures associated with a severe form of epilepsy called Lennox-Gastaut Syndrome.  Serious skin reactions have not generally been associated with other benzodiazepines.

The FDA recommends that patients should not stop taking Onfi without first talking to their health care professionals.  Stopping Onfi suddenly can cause serious withdrawal problems, such as seizures that will not stop, hallucinations (hearing or seeing things that are not real), shaking, nervousness, and stomach or muscle cramps.

The FDA has revised the Onfi drug label to add information about the risk for serious skin reactions to the Warnings and Precautions section and to the Medication Guide.

If you or someone you know has been injured by Onfi, call Longo Legal, PLLC to find out if you have a potential claim. The first step is to get some preliminary information over the phone. The initial phone call and consultation cost you nothing. You will not pay Longo Legal, PLLC anything towards your Onfi lawsuit unless a recovery is made on your behalf. Call Longo Legal at (855) 566-4648 to see if you qualify.

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