GlaxoSmithKline’s Avandia-related problems continue. This week, the company announced that it had revised its labeling for Avandia packaging in line with the Food and Drug Administration’s directives. The company has also settled more Avandia injury and wrongful death lawsuits for $250 million.
The labeling on the Avandia packaging has now been modified to restrict the use of rosiglitazone, the key ingredient in Avandia, to patients already taking the drug or those who have not found any benefit through any other anti-diabetes drugs. According to the label, rosiglitazone may be prescribed only to patients who are unable to achieve adequate glycemic control with other diabetes medications. The label specifically restricts the use of Avandia to those who have decided not to take pioglitazone for medical reasons.
Earlier this year, the Food and Drug Administration disappointed California pharmaceutical liability attorneys by stopping short of a complete ban on the medication. The new and improved labeling has been part of the FDA’s conditions for keeping Avandia on the market. The label would restrict its use to far fewer patients. The European Union was not in the mood to be as lenient with GlaxoSmithKline. Earlier this year, the EU medicine agency imposed a complete ban on the sale of Avandia.
The anti-type II diabetes drug has been linked to cardiac vascular problems, including heart attacks among users. This has been the basis of thousands of lawsuits filed against GlaxoSmithKline. Avandia has also been linked to other health issues, including eye disorders and a higher risk of osteoporosis in women.
Also last week, GlaxoSmithKline announced its latest settlement with personal injury and wrongful death plaintiffs. The company is to pay out $250 million in settlement of at least 5,500 lawsuits.