Label Changes for:
Evoclin (clindamycin phosphate) Foam
Changes have been made to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – January 2012
- including pseudomembranous colitis.... added
5 WARNINGS AND PRECAUTIONS
- Concomitant topical acne therapy should be used with caution since a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. If irritation or dermatitis occurs, clindamycin should be discontinued
- Avoid contact of EVOCLIN Foam with eyes, mouth, lips, other mucous membranes or areas of broken skin....
6 ADVERSE REACTIONS
6.2 Postmarketing Experience
- colitis (including pseudomembranous colitis), and hemorrhagic diarrhea