On December 3, 2013, the FDA issued a safety announcement stating they had approved an updated drug label for Onfi that includes a Warnings and Precautions statement describing the risk of serious skin reactions associated with taking the drug. According to the FDA, these "rare but serious skin reactions, called Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), can occur any time during Onfi treatment."
In the cases where it is believed Onfi caused SJS/TEN the patients required hospitalization. In at least one case the patient was ultimately left blinded. In one extreme and unfortunate case it is believed the patient died as the result of Onfi side effects.
Onfi, or Clobazam, was approved by the FDA in October 2011 for the treatment of Lennox-Gastaut Syndrome (LGS). Since approval, Onfi has since been prescribed to approximately 31,000 patients in the United States. The drug has only been approved for patients over the age of two (2).
Onfi is a benzodiazepine medication, and anyone taking the medication should thoroughly read the Medication Guide. Additionally, those taking the drug should consult with their doctor before discontinuing the medication. Those who suddenly discontinue using Onfi are at risk of developing the following serious withdrawal symptoms:
The National Institute of Neurological Disorders and Stroke has assembled a guide to inform the general public about LGS that can be found here. The key takeaways from this guide are:
Those taking Onfi and develop SJS/TEN may be able to sue their medical provider and/or Lundbeck, Onfi's U.S. distributor, to recover for their pain and suffering, medical costs, and potentially even punitive damages. If you or a loved one is taking Onfi and has developed a serious side effect it's important to speak with an experienced Onfi lawyer to discuss your legal options.
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Information page provided by the National Institute of Neurological Disorders and Stroke
The FDA warns using Onfi can lead to serious and dangerous side effects including death.
Onfi's product page available on lundbeck.com - Onfi's U.S. distributor