GSK Finalizes New Label Language for Avandia (rosiglitazone)

MedPage Today (2/7, Gever) reported that GlaxoSmithKline has finalized new label language for Avandia (rosiglitazone) restricting the drug’s use to patients already taking it or to those who have failed other antiglycemic drugs.”  In addition, Avandia (rosiglitazone)  ”may be started only in patients who ‘are unable to achieve adequate glycemic control on other diabetes medications, and, in consultation with their healthcare provider, have decided not to take pioglitazone (Actos) for medical reasons.’”

HeartWire (2/7, O’Riordan) reported that Avandia’s new label has been changed to highlight the increased cardiovascular risks, noting in a boxed warning that the drug was associated with a significantly increased risk of MI.” The new label also highlights the “lack of comparative clinical trials between rosiglitazone and pioglitazone but notes that pioglitazone, in a study compared with placebo, was not associated with an increased risk of death or MI.” In addition, the boxed warning “includes previous caveats that rosiglitazone is not recommended in patients with symptomatic heart failure and that it can exacerbate congestive heart failure in some patients.”

GSK to Settle Rosiglitazone (Avandia) Lawsuits

Bloomberg News (2/8, Feeley) reported that GlaxoSmithKline PLC agreed to pay more than $250 million to resolve about 5,500 claims related to its Avandia (rosiglitazone maleate) diabetes drug.”  GlaxoSmithKline officials said they have updated Avandia’s warning label to include safety restrictions ordered by federal regulators, who cited studies showing the drug poses an increased risk of heart attack and stroke for some users.  The label now warns users that the drug is only intended for consumers who can’t control their blood-sugar levels with other diabetes drugs.