When you wish upon a star… Ever the optimist, Garnier believes that a tougher FDA warning on the Avandia productd label may not be a disaster for the diabetes med. When asked whether Avandia could return to its former level of profitability even with a second so-called black-box warning, the Glaxo ceo tells Reuters: “Absolutely. It all depends on what the language is.”

The FDA is expected - any day - to decide on a labeling change, which may very well carry a second Black Box warning linking Avandia to an increased risk of heart attacks. Last week, Canada’s health ministry severely restricted use of the pill. The regulatory activity follows a controversial meta-analysis in the New England Journal of Medicine last May that found Avandia linked to a 43 percent increased risk in heart attacks, which sent scrips of the $3 billion drug plummeting.

“It’s not the black box that matters or the lack of black box, that’s not important to me; it’s - what is it saying?” he tells Reuters.
And he Garnier argues that it is important to keep in perspective the very small heart attack risk of two patients per 10,000 identified in the meta-analysis and he expects the FDA to adopt a “balanced” approach.

“The absence of Avandia or lack of availability of Avandia would actually create a problem,” he concedes to Reuters. “Hopefully, some of those patients will come back and realize that things are not the way they’ve been portrayed at the beginning of this unfortunate issue.”

The FDA has been reviewing Avandia labeling since July, when an advisory panel voted to keep the pill on the market but with new warnings. Avandia already carries a Black Box warning for heart failure and, as Reuters notes, a warning for the risk of heart attack would be more serious.