boost for global diclofenac gel market, page-12

With respect to the risks associated with topical diclofenac it is important to understand that despite the FDA's new warning (2009) requirement to include all products containing diclofenac regardless of manner of administration, there had been NO incidents of liver damage reported resulting from the use of topical diclofenac.

http://www.arthritistoday.org/news/drug-warning-liver-damage025.php

"According to a spokeswoman for the Food and Drug Administration, the cautions, which resulted from an internal review, apply to both the pills and topical products, though the agency says it has only received reports of liver damage related to the pill forms of the drug through its Adverse Event Reporting System (AERS)."

Even with oral diclofenac, liver related adverse side effects are relatively rare.

In a classic double blind clinical study of 17,289 patients administered either oral diclofenac ot 150 mg/day or oral etoricoxib at 60 or 90 mg/day, for a mean duration of 16 months, exactly four (4) patients required hospitalization for liver related side effects associated with diclofenac. There was no mortality associated with diclofenac over the duration of the study.

One commentator noted that (oral) diclofenac-induced liver injury in clinical trials "is as rare as hen's teeth."

http://www.ncbi.nlm.nih.gov/pubmed/19174782

Adverse hepatic side effects resulting from the use of topical diclofenac are virtually unheard of.

I stand by my remark that inclusion of topical diclofenac in the FDA's label warning requirements is an example of an overabundance of caution by the FDA.