Just as Allergan pleads guilty to a misdemeanor for misbranding in relation to off-label promotion of its widely used Botox (see this), the drugmaker was also tagged by the FDA for running an ad for its Acuvail anti-inflammatory that the agency deemed misleading for overstating efficacy and omitting risk information.

Acuvail is an non-steroidal anti-inflammatory drug, or NSAID, that is used Acuvail is used to treat pain and inflammation after cataract surgery. But a recent two-page ad - which features a row of four diamonds that range from small and dull to large and sparkly - suggests the drug has “enhanced” and is superior to other ocular NSAIDs. The FDA, however, says this isn’t so, and goes on to spank Allergan for implying Acuvail improves outcomes and patient comfort, and using language that broadens the approved indication.

The agency goes on to note in its warning letter that Allergan omitted important risk info from the fine print in its ad. Specifically, tne ad should have made clear that ocular NSAIDs may cause increased bleeding of ocular tissues in connection with ocular surgery,” and that Acuvail should not be administered while wearing contact lenses. Of course, cataract patients may have difficulty reading the fine print, anyway, so perhaps someone at Allergan figured omitting such info would hardly be missed.

Given the effort Allergan made to boost Botox sales and this latest, albeit smaller transgression, this is certainly a company to watch - especially if you spend your time tracking compliance, or the lack thereof.