Food and Drug Administration Warns of Dangers From Clobazam

Onfi (Clobazam) is a benzodiazepine.  Clobazam affects chemicals in the brain that may become unbalanced and cause anxiety.  Clobazam is used in combination with other medications to treat seizure disorders such as Lennox-Gastaut syndrome, a type of childhood epilepsy that causes developmental and behavioral problems.

On December 3, >2013, the Food and Drug Administration issued a public warning that this drug could cause a rare but serious skin reaction that can result in permanent harm or even death.  The FDA mandated changes in the Onfi (Clobazam) drug label and the Patient Medication Guide to describe the serious and potentially lethal risks.

The two most serious reactions are Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). Although these two conditions can occur at any time during the drug’s use, they occur most frequently during its initial phase. The medication protocol recommends that this drug is to be taken for eight weeks and discontinued, then restarted. The restarting phase is thought to be one of the more dangerous times.

The FDA stated that people taking this medication should seek immediate medical treatment if they develop any type of rash, blistering or peeling on their skin, sores in their mouth, or hives. The warning goes on to urge doctors to discontinue use of the drug and consider alternative medications at the first sign of a rash that may be linked to the drug.

In addition to rashes, other early warning signs of Stevens-Johnson syndrome are fever, fatigue, and sore throat. As the disease progresses, ulcers may begin to form around the mouth, lips, and genital areas.

If you, or somebody you know and love, has been injured taking Onfi or any other prescription medication, contact the personal injury lawyers of Roberts and Roberts. For nearly 30 years, these personal injury lawyers have held manufacturers including manufacturers of dangerous drugs accountable for the injuries they cause. The call costs you nothing… it could mean everything.

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