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News Articles >> Avandia: A New Black Box Warning, and a ..
Avandia: A New Black Box Warning, and a Reprieve from the FDA
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| November 18, 2007. By Gordon Gibb |  RSS  Del.icio.us  Seed Newsvine  Facebook |
Washington, DC: As some had predicted, GlaxoSmithKline caved to sustained pressure by the US Food and Drug Administration (FDA) and agreed to add a second black box warning for Avandia, the diabetes drug linked to increased risk of heart attack.
However, the warning is somewhat watered-down, and in the absence of any unforeseen, blockbuster medical revelations, the FDA has effectively granted Glaxo a seven-year reprieve from further scrutiny.
Not only that, but the FDA waited a long time for this latest black box warning to take effect. On August 14th the FDA ordered Avandia, together with all drugs in its class to carry a black box warning pertaining to the increased risk of heart failure. However it was two weeks earlier, on July 30th, when the FDA recommended a black box warning against the risk for ischemic events, or heart attack—the same day it voted overwhelmingly to leave Avandia on the market.
That's a three and a half month wait.
Avandia, a hugely popular drug for the treatment of Type 2 Diabetes, burst onto the market in 1999 and became a stellar performer for GlaxoSmithKline right out of the gate, in spite of alarm bells which began sounding barely a year into its existence.
Since then, it's been a roller coaster ride along a track littered with safety concerns, accusations of cover-up and inside regulatory influence. The bells tolled, but no one listened until this past spring, when a study published in the New England Journal of Medicine (NEJM) noted a 43 per cent increased risk of heart attacks in Avandia patients.
The news reverberated around the world and a waffling FDA, having already turned down a black box warning recommended by one of its own officials in March of 2006, finally crystallized a response and started talking black box warnings. On August 14th, it did just that—requiring all diabetes drugs in the Avandia class (including competitor Actos) to warn against heart failure. That concession was partly out of Glaxo's defense that while Avandia was under the gun and in the spotlight, it was no worse than any other diabetes drug including rival Actos, made by Takeda Pharmaceuticals.
This latest black box warning, announced three days ago, is significant in that it addresses the much more serious risk for heart attack. Unlike heart failure, which is a chronic condition that presents as a heart unable to properly pump blood, heart attack carries a higher concern in that an ischemic event can occur without warning, and can prove fatal. Diabetes patients are generally known to carry a higher risk for cardiovascular complication.
And yet, the warning comes with a bit of an escape clause for Glaxo, in that the "overall data are not conclusive." The latter is most likely a concession from an indecisive FDA which, in spite of Avandia's history and the damning NEJM study published in the spring, claims it doesn't have enough evidence to conclude that the risk of heart attacks, or ultimately death amongst Avandia patients, is any more severe than for those taking other diabetes medications.
Why then, are the others not facing the same black box warning? And given the warning signs that have been surfacing since 2000 about Avandia, what more conclusive evidence does the FDA need?
Those other manufacturers of diabetes drugs did not leave the FDA trough without a slight dribble on their own chins, by way of a recommendation that Avandia competitors be required to add to their respective labels language which suggests their product had not been proven to reduce cardiovascular risk.
A concession to Avandia by the FDA? Perhaps. But even with the label change looming, in view of the fact Avandia is the only diabetes drug castigated for a link to heart attack, Takeda is gleefully trumpeting Actos as a safer alternative to Avandia.The Japanese manufacturer has benefited from Avandia's troubles since the spring, with sales on the upswing while Avandia tumbled and doctors switched their patients to a similar drug that carried less risk.
The FDA requirement of a new black box warning for Avandia alone serves as a huge advantage for Actos, as it rolls out a neatly-packaged promotional campaign akin to a gift under the tree with a pretty bow and tag that reads 'Merry Christmas from the FDA.'
Meanwhile, in an effort to either placate the FDA or to buy time—or both—GlaxoSmithKine has agreed to undertake a long-term study in an effort to determine once and for all if Avandia is as dangerous as people think it is. While the FDA has asked to see interim data, the study is expected to take four or five years to complete, and a final report is not due until March of 2014. Given the FDA's habit of waiting for final results before making any kind of binding decision, it is reasonable to assume Avandia will be around at least until then. A thin shell, perhaps, of the once-robust sales performer—but a viable competitor just the same.
And that will tally 14 years that a potentially dangerous drug has been allowed to remain on the market, under such a dark cloud of suspicion.
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If you or a family member have used Avandia and have suffered heart attack or liver damage after taking Avandia, please contact a lawyer involved in a possible [Avandia Lawsuit] who will review your case at no cost or obligation.
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