FDA Updates Ritonavir (Norvir) Label with New Safety Information

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We want your feedback!

Posted December 2011

“On December 7, 2011, the Food and Drug Administration approved the following revisions to the Norvir (ritonavir) tablets, capsules and oral solution product labeling:

“The Contraindications section was updated to include toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome.

“The Warning and Precautions, Adverse Reactions and Postmarketing Experience sections were updated to include toxic epidermal necrolysis (TEN) …

“Section 7: Drug Interaction was updated to include information regarding the anticancer agents dasatinib and nilotinib and fentanyl.”

The updated label will be available at the FDA Web site.

More information is available:

FDA: Press release