Days after FDA ordered a second black-box warning for GlaxoSmithKline's controversial diabetes drug Avandia, Takeda is looking to capitalize on the news with a national print ad campaign for Actos.

The rapid-response ad, by AbelsonTaylor, launched today in 82 major market newspapers and national newsweeklies like Time and Newsweek, advising readers with type 2 diabetes that “Actos has been shown to lower blood sugar without increasing your risk of having a heart attack or stroke.”

Takeda said it wanted to let patients scared off treatment by the cloud over Avandia that not all oral diabetes drugs are alike when it comes to heart risks.

“A lot of patients on oral anti-diabetes drugs seemingly left the market over the last six months,” said Shay Weisbrich, general manager, diabetes for Takeda. “The confusion goes way beyond TZDs to all classes of drugs. This is a very unusual step for us, but we felt compelled to reach out to patients directly with a message of clarity and get them to talk to their physicians.”

Indeed, while the possible cardiovascular issues linked to Avandia may not be a class effect, the drop in sales resulting from the negative publicity surrounding it has been. According to IMS Health, the market for insulin sensitizers was already down 2% from January to June over the same period last year. For that period, Actos sales were up 11% year-on-year and the drug gained market share, going from 53.7% for all of 2006 to 59.2% for the first half of 2007 while first half sales of Avandia fell 16% year-on-year, and the drug's share of the market fell from 46.3% in 2006 to 40.8%.

Those numbers don't really reflect the beating the category has taken. FDA asked GSK and Takeda to add a warning for congestive heart failure patients in May--a fact only disclosed in June, during congressional hearings on Avandia's safety. But Takeda's drug showed none of the worrisome cardiovascular signals that Avandia did in large-scale clinical trials like Takeda's PRO-Active trial – a fact the firm fears was lost on patients. Ad copy reads: “Actos … has a major study in its product label, which showed that it did not increase the risk of having a heart attack or stroke.”

“You can see how patients are confused,” said Weisbrich, referring to the fallout from the CHF warning coming to light amid questions over Avandia's cardiovascular safety. “They see ‘Heart,' and they think it's all the same, but these are two very distinct risks.”

The ads were slated to run for several weeks. Takeda also supplied physicians with sales aids, a letter from its medical director and Q&A tear sheets on the matter for patients while reaching out to select reporters with agency Ketchum.