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June 06, 2007

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John Mack

Takeda would now find it difficult to do DTC advertising of Actos to "reach out" to any audience, not just African-Americans. The FDA just announced that it requested both GSK and Takeda to put "black box" warnings on their respective product labels for Avandia and Actos.

In the past, this meant that "reminder ads" -- where only the drug name is mentioned, not the indication -- would be strictly prohibited. To some degree that is a mute point now that most companies (but NOT Takeda) have abandoned reminder ads altogether.

Realistically, however, all DTC ads for these products would now have to highlight the cardiovascular concerns, which would make the ads less than effective, to say the least!

Carol

It is interesting to see how Avandia started out. Now with Actos, I think we need to really determine whether it is safe for patients or not.

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