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FDA Warns that Anti-Seizure Drug Poses Risk of Serious Skin Reactions

The United States Food and Drug Administration (FDA) has issued a warning against Onfi (clobazam), a popular anti-seizure drug that has been linked to incidents of serious skin reactions. Although rare, the skin reactions caused by the drug can cause permanent harm and even death in the worst case scenarios. Identified as the Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), the skin reaction is said to occur most often within the first eight weeks of Onfi treatment. However, users should be warned that the adverse skin reactions can happen any time while using Onfi; they can even occur if the medication is stopped and then started again.

After a study by the FDA in which all cases of SJS and TEN resulted in hospitalization of the patients, the administration acted to make changes to the product's label. Now, both the Onfi drug label and the patient Medication Guide include information describing the risk of serious skin reactions when using the product. It's recommended that patients using Onfi be closely monitored for any signs of SJS and / or TEN, and observation should be particularly intense during the first eight weeks of treatment as well as any time that the medication is re-introduced to an individual's system. Healthcare professionals have been advised to discontinue use of the product and switch to an alternate form of treatment if any rash-like symptoms appear in the patient.

For patients currently taking Onfi, you should immediately see a doctor if you experience any of the following:

  • Rash
  • Mouth sores
  • Peeling skin
  • Hives

Given the risks associated with suddenly stopping and restarting the medication, patients are not advised to cease use of the drug upon experiencing potentially dangerous symptoms. Instead, see a healthcare professional as immediately as possible. After your health has been properly attended to, you can contact The Senators Firm for professional legal representation from a dangerous drug attorney at our office. Our toll-free line is open 24 hours a day, 7 days a week, so don't hesitate to contact us at any time of the day or night. We can be reached at 800-773-0849.

Categories: Defective Drugs
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