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CASE UPDATE: FDA Issued Drug Safety Communication
December 3, 2013 - The U.S. Food & Drug Administration (FDA) issued a Drug Safety Communication that says Onfi can cause rare but serious skin reactions that can result in permanent harm and death. The Drug Safety Communication came after a review of adverse events linked to Onfi to 20 skin reactions involving Stevens-Johnsons Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). The FDA is advising clinicians to closely monitor patients taking Onfi for SJS and TEN, especially at the start of therapy or when the drug is reintroduced.
Onfi is a prescription drug used, in conjunction with other medications, to treat Lennox-Gaustaut Syndrome, a severe form of childhood epilepsy that can cause developmental and behavioral issues. Clobazam, the main ingredient used in Onfi, is thought to affect the neurotransmitters, or other substances, in the brain that control how the brain cells communicate.
Manufactured by the Danish pharmaceutical company Lundbeck, the FDA approved Onfi in 2011 as an add-on treatment for seizures in children aged 2 or older or in adults who suffer from seizures associated with Lennox-Gaustaut Syndrome. By September of 2013, over 30,000 Americans had been prescribed Onfi.
According to the manufacturer, the side effects of Onfi include:
The following injuries could be a side effect of Onfi usage:
Stevens-Johnsons Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) are rare but severe, life-threatening skin reactions that cause the top layer of skin to detach and fall off in a large sheet. Sloughing skin may appear burned, while blisters may also develop on mucous membranes located at the eyes, mouth, and genitals and ultimately spread from all over the body to inside the intestines, lungs, and stomach.
Onfi skin reactions are extremely dangerous, painful, and disfiguring and can lead not only to life-threatening infections, but also organ damage, blindness, and death. It is important to immediately seek medical attention if you or a loved one are experiencing side effects.
If you feel that you developed Stevens-Johnsons Syndrome or Toxic Epidermal Necrolysis as a result of your Onfi usage, you should consider contacting an Onfi lawyer.
If you have any questions, please contact TorHoerman Law.
"Clobazam." Epilepsy Foundation, www.epilepsy.com/medications/clobazam.
"Onfi Uses, Dosage, Side Effects & Warnings." Drugs.com, Drugs.com, 28 Sept. 2016, www.drugs.com/onfi.html.
Last Modified: July 23rd, 2019 @ 03:01 pm
Onfi (clobazam) is an anti-seizure drug in the category of drugs called benzodiazepines. Onfi is often prescribed in combination with other medications in an attempt to prevent seizures associated with a severe form of epilepsy called Lennox-Gaustaut Syndrome. However, Onfi usage has been linked to the development of Steven-Johnsons Syndrome and Toxic Epidermal Necrolysis.
At this time, TorHoerman Law is not accepting Onfi lawsuit cases.
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