Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
*Addition of a history of hypersensitivity to the drug or its ingredients
*Addition of “urinary retention” and “hypothermia” to Section 6.2
*Revision of Section 8.1; Pregnancy to include results from completed studies
WARNINGS AND PRECAUTIONS
- Serious Dermatological Reactions - Serious skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported with ONFI in both children and adults during the post-marketing period. Patients should be closely monitored for signs or symptoms of SJS/TEN, especially during the first 8 weeks of treatment initiation or when re-introducing therapy. ONFI should be discontinued at the first sign of rash, unless the rash is clearly not drug-related. If signs or symptoms suggest SJS/TEN, use of this drug should not be resumed and alternative therapy should be considered.