Factbox: Potential outcomes for Glaxo diabetes drug vote

(BestGrowthStock) – A U.S. advisory panel is scheduled to vote later on Wednesday on whether to recommend the removal of GlaxoSmithKline’s controversial diabetes drug Avandia from the market, after wading through hundreds of pages of conflicting data on the pill’s heart risks.

The Food and Drug Administration panel of experts from outside the agency consists of an unusually large 33 members, and they have five options for regulatory action.

The FDA usually follows the recommendations of its advisory panels, but the result of Wednesday’s vote may not be clear-cut.

The panel members each get one vote on a range of options — from keeping Avandia on the market and removing the current heart-attack warning, to pulling it from the U.S. market — or they may abstain from voting.

Here are the five options the FDA advisory panel members may select on Wednesday, at the conclusion of a two-day meeting:


* Allow continued marketing of Avandia and revise the current label to remove the boxed warning and other warnings regarding increased risk of heart attacks and related problems


* Allow continued marketing and make no changes to the current label


* Allow continued marketing and revise the current label to add additional warnings (such as, recommending against use for certain patient populations, or limiting use to patients who do not respond to other medications)


* Allow continued marketing and revise the current label to add additional warnings, AND add additional restrictions on use (such as, restricting prescribing to certain physicians or requiring special physician and patient education)


* Withdrawal from U.S. market

Before debating those five options, the panel is scheduled to vote on a series of questions about whether Avandia increases the chances of a heart attack or death compared with other diabetes drugs and with Actos, a medication made by Takeda Pharmaceutical Co that is in the same class as Avandia.

The panel is also due to consider a final question on whether a clinical trial called TIDE should be allowed to continue. The study could provide a more definitive answer on Avandia’s heart risks. But critics argue it is wrong to wait years for those results and there is enough evidence to withdraw Avandia now.

(Reporting by Karey Wutkowski and Lisa Richwine; Editing by Tim Dobbyn)

Factbox: Potential outcomes for Glaxo diabetes drug vote