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Pharmaceuticals / Regulatory Affairs

Scilex Petitions FDA to Pull Unapproved Lidocaine Patches

Feb. 6, 2019
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Scilex Pharmaceuticals urged the FDA to remove unapproved lidocaine patches from the market and issue guidance on the marketing of such products.

Scilex, which manufactures the Ztlido lidocaine patch, noted in a citizen petition that the FDA issued public health advisories in 2007 and 2009 warning about potential serious adverse events associated with topical use of lidocaine, and in 2018 it issued a safety announcement warning about risks of methemoglobinemia, a blood disorder caused by local anesthetics, and identified patients developing the disorder while using five percent topical lidocaine patches.

Numerous over-the-counter lidocaine patches that do not conform to the FDA’s 1983 tentative final monograph have hit the market, Scilex noted. Issues such as the consistency of adhesion, the amount of residual drug use and potential for irritation and sensitization all should be considered in developing OTC lidocaine patches, according to the petition.

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