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CME/CE

FDA Safety Communication: Clobazam Linked With Serious Skin Reactions

  • Authors: News Author: Robert Lowes
    CME Author: Laurie Barclay, MD
  • CME/CE Released: 12/24/2013
  • THIS ACTIVITY HAS EXPIRED
  • Valid for credit through: 12/24/2014
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Target Audience and Goal Statement

This article is intended for primary care clinicians, neurologists, and other specialists who care for patients with seizure disorders treated with clobazam.

The goal of this activity is to provide medical news to primary care clinicians and other healthcare professionals in order to enhance patient care.

Upon completion of this activity, participants will be able to:

  1. Describe an US Food and Drug Administration safety bulletin regarding clobazam.
  2. Identify adverse skin events reported with clobazam.
  3. List recommendations for clinicians and patients to avoid adverse skin events reported with clobazam.


Disclosures

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Medscape, LLC, encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration, at first mention and where appropriate in the content.


Author(s)

  • Robert Lowes

    Robert Lowes is a journalist for Medscape Medical News. A former senior editor at Medical Economics magazine and contributor to numerous healthcare publications, Robert has covered medicine from almost every conceivable angle — public policy, managed care, education, ethics, medical malpractice, information technology, billing and collections, waiting-room design, and first-degree murder. His articles have won major awards such as first place in the annual journalism competition of the National Institute for Health Care Management, and several have been republished in books. Robert also is an anthologized poet. He can be contacted at [email protected]

    Disclosures

    Disclosure: Robert Lowes has disclosed no relevant financial relationships.

Editor(s)

  • Amy Nadel

    Disclosures

    Disclosure: Amy Nadel has disclosed no relevant financial relationships.

CME Author(s)

  • Laurie Barclay, MD

    Freelance writer and reviewer, Medscape, LLC

    Disclosures

    Disclosure: Laurie Barclay, MD, has disclosed no relevant financial relationships.

CME Reviewer(s)

  • Yullee C. Chui

    Program Manager, Medscape, LLC

    Disclosures

    Disclosure: Yullee C. Chui has disclosed no relevant financial relationships.


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    This enduring material activity, Medscape Education Clinical Briefs has been reviewed and is acceptable for up to 39 Prescribed credits by the American Academy of Family Physicians. AAFP accreditation begins September 1, 2013. Term of approval is for 1 year from this date. Each Clinical Brief is approved for .25 Prescribed credits. Credit may be claimed for 1 year from the date of each Clinical Brief. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

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This activity is designed to be completed within the time designated on the title page; physicians should claim only those credits that reflect the time actually spent in the activity. To successfully earn credit, participants must complete the activity online during the valid credit period that is noted on the title page. To receive AMA PRA Category 1 Credit™, you must receive a minimum score of 75% on the post-test.

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CME/CE

FDA Safety Communication: Clobazam Linked With Serious Skin Reactions

Authors: News Author: Robert Lowes CME Author: Laurie Barclay, MDFaculty and Disclosures
THIS ACTIVITY HAS EXPIRED

CME/CE Released: 12/24/2013

Valid for credit through: 12/24/2014

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Clinical Context

The exact mechanism of action of clobazam, a 1,5-benzodiazepine, is not completely understood. However, it is thought to involve potentiation of GABAergic (γ-aminobutyric acid) neurotransmission via binding at the benzodiazepine site of the GABAA receptor.

In 2011, the US Food and Drug Administration (FDA) approved clobazam as adjunctive therapy to treat seizures that accompany Lennox-Gastaut syndrome, a severe form of epilepsy, in patients who are at least 2 years old.

According to the FDA, benzodiazepines other than clobazam generally are not associated with serious skin reactions.

Study Synopsis and Perspective

The antiseizure drug clobazam (Onfi) can trigger rare but potentially fatal skin reactions, the FDA announced. The risk for these serious skin reactions is now described in FDA-approved changes to the Onfi drug label and the patient Medication Guide.

The agency approved clobazam, a benzodiazepine, in 2011 as an add-on therapy to treat seizures that accompany a severe form of epilepsy called Lennox-Gastaut syndrome. The FDA said that other benzodiazepines generally are not associated with serious skin reactions.

For clobazam, the skin reactions to watch for are Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which may result in permanent harm or death. Patients taking clobazam can experience these disorders at any time, but the risk increases during the first 8 weeks of treatment or when treatment resumes after it was stopped. All of the cases of these 2 adverse events identified by the FDA landed patients in the hospital, with 1 patient going blind and another dying.

The FDA advises clinicians to closely monitor patients taking clobazam for SJS and TEN, especially at the start of therapy or when the drug is reintroduced. Signs and symptoms include rashes, blistered or peeling skin, mouth sores, and hives. Clobazam should be halted at the first appearance of a rash, and if other signs and symptoms point to a serious skin reaction, the therapy should not be resumed.

Clinicians also should instruct patients taking clobazam to seek medical care immediately if they spot a rash or some other sign of hypersensitivity, according to the FDA. However, patients should not stop taking clobazam without first consulting their healthcare provider, because suddenly halting treatment on their own can trigger serious withdrawal problems such as persistent seizures, nervousness, and hallucinations.

More information on the FDA safety change regarding clobazam is available on the FDA Web site.

To report problems with clobazam, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

Laurie Barclay, MD, has contributed to this synopsis.

Clinical Implications

  • The FDA announced that clobazam can cause rare skin reactions potentially resulting in permanent harm and even death. FDA-approved changes to the Onfi drug label and the patient Medication Guide now describe the risk for serious adverse skin events of SJS and TEN.
  • Dermatologic signs and symptoms caused by clobazam may include rashes, blistered or peeling skin, mouth sores, and hives. SJS and TEN may occur at any time during treatment with clobazam, but the risk is highest during the first 8 weeks of treatment or when treatment is resumed after discontinuation. All cases of clobazam-induced SJS and TEN identified by the FDA required hospitalization. One of these cases resulted in blindness and a second case in death.
  • Monitoring for skin reactions in patients treated with clobazam is particularly important when therapy is initiated or reintroduced. At the first appearance of a rash, clobazam should be stopped. Treatment should not be resumed if there is other evidence of a serious skin reaction. Clinicians should advise patients who experience a rash or some other sign of hypersensitivity while taking clobazam to seek medical attention immediately.

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