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Two wide prescribedepilepsydrugs have been linked to a rarefied but serious sensitized reaction that can be biography - menacing , the U.S. Food and Drug Administration ( FDA ) warns .
Worldwide , more than 40 serious cases of the response , have it away asDrug Reaction with Eosinophilia and Systemic Symptoms(DRESS ) syndrome , have been detect in people take the drugslevetiracetamandclobazam . The former is more commonly know under stigma names such as Keppra or Keppra XR , and the latter is brand as Onfi or Sympazan .
The FDA issued the warning about two widely prescribed anti-epilepsy drugs, levetiracetam and clobazam.
Although the risk of developing DRESS syndrome is rare , the response can be pestilent if not diagnose and treated quickly . If anyone taking levetiracetam or clobazam develop any strange symptoms , such as an unexplained roseola , febrility or swollenlymph nodesat any time while taking the drugs , they should " go to an emergency brake room immediately , " the FDA aver in itsannouncementon Nov. 28 .
While the FDA encourage patient and health care providers to be on the watch for DRESS , the federal agency advises that anyone taking levetiracetam or clobazam should not stop taking the medication without first spill the beans to their health care supplier . Abruptly stopping these medicines could lead to " uncontrolled seizure , " the FDA admonish .
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Levetiracetam and clobazam are both widely prescribed in the U.S. for epilepsy , a continuing brain experimental condition that have recurrent seizures . In 2022 , for model , an estimated 12 million levetiracetam prescriptions and almost 800,000 clobazam prescriptions were dispensed from U.S. outpatient pharmacies . Overall , anestimated 1.2 % of the U.S. populationhas active epilepsy , stand for they ’re currently taking medicine to control it and/or they ’ve had at least one ictus in the past year .
Levetiracetam is used to control specific types of seizures associated with epilepsy , includingpartial capture , signify those that affect just one part of the brain , andmyoclonic seizures , which cause brief muscle jerks . Clobazam is a depressant that works by slow up down the activity of the centralnervous system of rules . It is sanction by the FDA to be used alongside other drug to control seizure associated with a severe form of epilepsy calledLennox - Gastaut syndrome .
To date , the FDA is cognisant of 32 serious cases of DRESS syndrome in children and adults who had been taking levetiracetam , and 10 cases in citizenry who were on clobazam . The agency hear of these cases after reviewing data reported to theFDA Adverse Event Reporting System ( FAERS ) databaseand assess other publish medical literature .
Most of the 42 patients had to go to hospital and meet medical treatment , and two of the patients died .
DRESS syndrome can be triggered by a wide variety of drugs , although it ’s usuallytriggered by a exclusive medicationin a someone ’s regime . symptom normally begin aroundtwo to eight week after initial exposureto the drug and may include febrility , hide rash , egotistical lymph nodes and a swollen face . The rash , which typically looks like flat - to - slightly - raise red-faced spots , is often one of the first symptoms and can spread to the trunk , arms and leg . However , not all patient role develop the rash .
DRESS syndrome can also lead toinflammationand accidental injury in various pipe organ , such as theliver , kidney andheart , which can potentially pass to dying .
DRESS syndrome can sometimes be fuddle with other serious reactions to medication that affect the skin , such asStevens - Johnson syndrome . However , both syndromes usually require treatment in a infirmary .
In brightness level of its announcement , the FDA now requires that manufacturer add warnings about DRESS syndrome to theprescribing informationand patientmedication guidesfor levetiracetam and clobazam . The destination is to inform patients and wellness care providers about the potential risks of the drugs and the early signs of DRESS syndrome .
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The agency also urges anyone to report any side effects they experience while take these drugs to the FDAMedWatchprogram .
This clause is for informational role only and is not meant to offer medical advice .
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