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PRODUCED BY AND FOR MEMBERS OF THE DEPARTMENT OF SURGERY December 2013 | Archived Issues

Mark Your Calendar


Surgery Grand Rounds

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Grand Rounds

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Surgery Scheduling

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FDA Warns About Clobazam; Boxed Warnings Summarized

Pharmacy Focus

The U.S. Food and Drug Administration has approved changes to the drug label and medication guide for the anti-seizure drug clobazam (Onfi®) to include a warning regarding the rare but serious risk of skin reactions called Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).

Also, a summary of FDA boxed warnings has been issued.

Regarding the clobazam warning, the FDA issued the following recommendations:

  • Monitor patients closely for signs or symptoms of SJS/TEN, especially during the first eight weeks of therapy or when reintroducing therapy.
  • Discontinue clobazam at the first sign of rash, unless the rash is clearly not drug related.

To learn more, visit this FDA Web page.

FDA Boxed Warnings Summarized

A summary of boxed warnings from the FDA has been issued. Click the PDF link below to see the summary.

FDA Boxed Warning Summary (PDF)