Johnson & Johnson receives FDA warning letter for Ultram ER video

The FDA posted a warning letter to its website on Tuesday stating that Johnson & Johnson committed serious violations of the agency's advertising regulations in a consumer webcast promoting Ultram ER (tramadol). The agency said the marketing material is false or misleading because it excludes and minimises the serious risks of the chronic pain drug and overstates its efficacy.

In addition, the regulator noted that the webcast "fails to convey any risks specific to Ultram ER" until the end of the video, "where it is unlikely to draw the viewer's attention." Overall, the presentation "undermines the communication of important risk information...and misleadingly [suggests] that Ultram ER is safer than has been demonstrated," the agency indicated. The FDA also commented that some statements made in the testimonial portion of the video "greatly misrepresent" the product's efficacy, in part by implying that treatment with Ultram ER results in "a positive effect on patients' overall mood (including the alleviation of depression) and interpersonal relationships."

The FDA requested that Johnson & Johnson stop using the promotional materials identified in the letter and provide a response to the regulator by May 27. Furthermore, the agency asked the drugmaker to detail a plan for disseminating "truthful, non-misleading, and complete corrective the audience(s) that received the violative promotional materials."

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