Saturday, September 24, 2016 2:13:27 PM
The delay in Rexista filing is most likely due to a safety concern. My best guess is that it has something to do with the "stigmatizing blue dye" that is touted as an ADF feature. If the drug is chewed, the abuser's teeth, lips, and oral mucosa are colored with a deep blue dye. This presents several dilemmas. First, every person who uses the drug as intended is going to be exposed to a biochemical (blue dye) which is meant only for the abuser. Blue dye will release from the tablet matrix and enter the G.I. tract of every user- not just the abusers. This practice was specifically identified as an ethical concern and disallowed by the FDA in previous ADF formulations which contained niacin as an aversive nasal irritant.
The second dilemma about the blue dye is related to specific toxicities of synthetic dyes. All currently-approved dyes for food & drugs are derived from petroleum or coal tar. Since the FDA began regulating dyes in the 1960's, all but 8 have been banned for human use due to specific, proven carcinogenic or teratogenic effects. Of the 8 dyes which remain legal, Blue #1 and Blue #2 are both banned in multiple European countries because they cause tumors in animal models.
Which blue dye is used for this purpose and what concentration of blue dye is required for the ADF effect? The company clearly describes the "stigmatizing blue dye" as an active part of their ADF and not just an additive colorant. Has a regimen of two daily doses of blue dye at this concentration been tested and proven to be safe? Risk of cancer and birth defects in proper users would prevent me from prescribing this drug for my patients, but the most acute risk of daily G.I. tract exposure from blue dye is the subject of an FDA Public Health Advisory.
http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditivesinSpecificProducts/InMedicalDevices/ucm142395.htm
Historic note: Until his life's destiny was further clarified, Robin Hood spent several years robbing from the rich and giving to the porcupines. (G. Larson 7/26/82)
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