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News Articles >> Avandia Second Black Box Warning Urged
Avandia Second Black Box Warning Urged
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| November 6, 2007. By Gordon Gibb |  RSS  Del.icio.us  Seed Newsvine  Facebook |
Washington, DC: The rocky and remarkable history of Avandia, and its impact on diabetes patients just keeps getting more interesting, and more unsettling now that it has been revealed that the US Food and Drug Administration (FDA) is pushing hard for a second black box warning.
The issuance of an additional black box warning in tandem to one already in place is considered the strongest response possible to a drug with serious side effects and potential health issues, save for taking it off the market entirely.
And that has been attempted.
GlaxoSmithKline introduced Avandia in 1999 for the treatment of Type 2 Diabetes. Almost immediately, it came under fire when a noted diabetes specialist went public with his concerns that Avandia had the potential for serious implications affecting the heart.
Thus began a serious of events that allegedly saw the drug maker attempt to silence, and discredit the whistleblower. GlaxoSmithKline was also accused of downplaying the risks, in an attempt to keep the drug viable, and to protect sales.
It's been a back-and-forth battle ever since, as the regulatory and medical communities have tried to get a handle on the real and perceived risks associated with diabetic patients taking Avandia, while the drug maker continues the parry and thrust of corporate fencing—the seemingly impossible challenge of keeping a drug emerging as a danger not only on the market, but also popular.
It was in late spring when GlaxoSmithKline's lance finally hit the floor, after the publication of an analysis by Dr. Steven Nissen in the New England Journal of Medicine found that Avandia use raised the risk of heart attack by 43 per cent. A tendency of the drug to promote weight gain and fluid retention serves as a further risk for congestive heart failure.
In August the FDA announced that Avandia would carry a black box warning with regard to the increased risk for heart failure.
And now comes word that the FDA is pushing for a second black box warning, this time pointing to the increased risk for heart attack. While heart failure presents as a weakened heart having difficulty pumping blood efficiently, an actual heart attack on the other hand, is considered to be a more serious condition.
Yet another damnation to Avandia emerged when the US Department of Veterans Affairs (VA) revealed last month that it is removing Avandia from its list of approved drugs, and will severely limit its use. The VA will recommend that patients currently taking Avandia may continue, but strongly urge doctors to discus the associated risk with their patients.
VA sales of Avandia represent about 8 per cent of total US Avandia sales, which have fallen an estimated sixty per cent since May.
The European Medicines Agency is also recommending a 'tightened' label for Avandia, although it is of the opinion that the benefits outweigh the risks for Avandia, and rival drug Actos.
It is Actos--known generically as pioglitazone maleate and manufactured by Takeda Pharmaceuticals--that is winning the sweepstakes for Type 2 diabetes patients at the present time. While Actos also poses health risks, it is considered less of a risk than Avandia, in some circles.
And the very argument that has lately consumed the European Medicines Agency, has also consumed the FDA and various panels over the past several months: in spite of substantial risks, do the benefits outweigh the risks for a majority of patients?
That's literally the million-dollar question for GlaxoSmithKline as opposition to Avandia, and related lawsuits mount.
And early this fall yet another study, published in Lancet, suggests a 72 per cent greater risk of heart attack and heart failure in cardiac patients with a history of heart disease taking Avandia.
The drug, known generically as rosiglitazone, was once GlaxoSmithKline's second-highest performer. But sales have been steadily dropping.
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