Avandia gets black-box warning

The following isn't a big shock, but it's still an important development--blockbuster diabetes drug Avandia will now carry a black-box warning. In addition to posting the warning on Avandia packaging, GlaxoSmithKline has also agreed to conduct a new Avandia trial, comparing the drug directly with Actos and other related drugs.

GlaxoSmithKline has struggled to maintain Avandia's reputation since a report came out earlier this year suggesting that the drug could be linked to a 43 percent increased risk of heart attacks in patients who took it.  Sales of the drug, once the world's best-selling diabetes medication, have fallen by half since the release of the journal article, after hitting $3.3 billion in 2006.

While the black-box designation is no picnic, Glaxo is actually getting kinder treatment here than it did elsewhere. The Canadian health program will no longer pay for Avandia as a stand-alone therapy, and European regulators are limiting its use to a subset of diabetes patients.

To find out more about Avandia's status:
- read this Chicago Tribune article

ALSO:  Elsewhere on the pharma front, Glaxo is battling FDA attempts to create a third class of drugs which would not require a prescription, but wouldn't be given to consumers until they got counseling from a pharmacist. Release

Related Articles:
Avandia controversy sparks FDA criticism. Report
Glaxo: Avandia's safe as other diabetes drugs. Report
Avandia critic: FDA launched smear campaign. Report
Diabetes expert issued harsh Avandia critique in 2000. Report

Post a comment