Safety

Flector Patch (diclofenac epolamine) 1.3% topical patch

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 2009

Elevations of one or more liver tests may occur during therapy with Flector Patch. These...
In clinical trials, meaningful elevations (i.e., more than 3 times the ULN) of AST (GOT) (ALT was not measured in all studies) occurred in about 2% of approximately 5,700 patients...
Almost all meaningful elevations in transaminases were detected before patients became symptomatic. Abnormal tests occurred during the first 2 months of therapy with diclofenac...
In postmarketing reports, cases of drug-induced hepatotoxicity have been reported in the first month, and in some cases, the first 2 months of therapy, but can occur at any time...
Physicians should measure transaminases periodically in patients receiving long-term therapy with diclofenac, because severe hepatotoxicity may develop without a prodrome of...
If abnormal liver tests persist or worsen, if clinical signs and/or symptoms consistent with...
To minimize the potential risk for an adverse liver related event in patients treated with Flector Patch, the lowest effective dose should be used for the shortest duration possible...