Two widely prescribed epilepsy The drug is associated with rare but potentially life-threatening serious allergic reactions, the U.S. Food and Drug Administration (FDA) warns.
More than 40 severe cases of the reaction, known as , have occurred around the world. Drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome has been detected in people taking drugs Levetiracetam and clobazam. The former is better known by his brand names such as Keppra and Keppra XR, and the latter by his Onfi or Sympazan brand names.
Although the risk of developing DRESS syndrome is rare, this reaction can be fatal if not diagnosed and treated promptly.If a person taking levetiracetam or clobazam develops unusual symptoms such as an unexplained rash, fever, or swelling. lymph nodes The FDA said you should “immediately go to the emergency room” any time you are taking the drug. announcement November 28th.
While FDA encourages patients and health care providers to be aware of DRESS, it advises that people taking levetiracetam or clobazam should not stop taking the drug without first consulting their health care provider. are doing. Stopping these drugs suddenly can cause “uncontrollable seizures,” the FDA warned.
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Both levetiracetam and clobazam are widely prescribed in the United States for epilepsy, a chronic brain disease that causes repeated seizures. in 2022For example, an estimated 12 million levetiracetam prescriptions and nearly 800,000 clobazam prescriptions were filled from outpatient pharmacies in the United States. as a whole, Estimated 1.2% of US population You have active epilepsy. This means you are currently taking medication to control your epilepsy or have had at least one seizure in the past year.
Levetiracetam is used to control certain types of seizures associated with epilepsy, such as: partial seizuresmeaning something that affects only one part of the brain. myoclonic seizures, causing short muscle spasms. Clobazam is a depressant that works by slowing down the activity of the central nervous system. nervous system. It is approved by the FDA to be used in combination with other drugs to control seizures associated with severe epilepsy. Lennox-Gastaut syndrome.
To date, FDA is aware of 32 severe cases of DRESS syndrome in children and adults who were taking levetiracetam and 10 severe cases of DRESS syndrome in people who were taking clobazam. The agency learned of these incidents after reviewing data reported to police. FDA Adverse Event Reporting System (FAERS) Database Evaluate other published medical literature.
Most of the 42 patients had to go to the hospital for treatment, and two of them died.
DRESS syndrome can be caused by a variety of drugs, but usually caused by only one drug In a person's regimen. Symptoms usually begin around: 2-8 weeks after first exposure The drug may cause fever, skin rash, swollen lymph nodes, and facial swelling. The rash usually looks like flat to slightly raised red spots and is often one of the first symptoms and can spread to the torso, arms, and legs. However, not all patients develop a rash.
DRESS syndrome may also be caused inflammation damage to various organs, liver,kidney, heartwhich can lead to death.
DRESS syndrome can be confused with other serious reactions to drugs that affect the skin. Stevens-Johnson syndrome. However, both syndromes usually require hospital treatment.
In light of this announcement, the FDA is requiring manufacturers to add a warning about DRESS syndrome to their product listings. Prescription information and patient Medication guide About levetiracetam and clobazam. The goal is to inform patients and health care providers about the potential risks of the drug and the early signs of her DRESS syndrome.
In light of this announcement, the FDA is requiring manufacturers to add a warning about DRESS syndrome to their product listings. Prescription information and patient Medication guide About levetiracetam and clobazam. The goal is to inform patients and health care providers about the potential risks of the drug and the early signs of her DRESS syndrome.
The agency also encourages anyone to report any side effects they experience while taking these drugs to the FDA. med watch program.
This article is for informational purposes only and does not provide medical advice.
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