The manufacturer of the Dsuvia painkiller, which was approved by the Food and Drug Administration amid substantial controversy, was taken to task by the agency for creating misleading ads that minimized the risks associated with the opioid medicine.
In a Feb. 11 warning letter, the FDA chastised AcelRx Pharmaceuticals (ACRX) of the “serious and potentially life-threatening risks” that may result from “accidental exposure to misplaced tablets” or overdoses involving the drug. The messages in question were used in a website banner ad and tabletop display that incorrectly suggested the extent to which Dsuvia is easy to administer as well as the proper daily dosage.
In the banner ad, for instance, the product was touted with the phrase ‘Tongue and Done.’ The FDA, however, argued that the messaging suggested it is a “simple, one-step process” to use Dsuvia, when there are “numerous administration steps” outlined in the product labeling, such as visually confirming the tablet is properly placed in the mouth.
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