Posts Tagged ‘ TIDE ’

A Muted Win For Avandia Manufacturer—But Stay Tuned…

July 15th, 2010. By Hunter West

So Avandia has been stayed from execution—for now—by virtue of a majority vote by an expert panel of experts brought together by the US Food and Drug Administration (FDA) that debated the drug’s safety and efficacy for two days this week. The Type 2 diabetes drug that has been under much fire for the past couple of years was further challenged by the long-awaited gathering which ended with a vote to leave Avandia, manufactured by GlaxoSmithKline (Glaxo), on the market for the time being.

But the victory for Glaxo is muted.

While the panel voted 20-12 to leave Avandia on the market, it will not likely be left alone. That’s because at least half of those voting ‘yay,’ according to the July 14^th edition of the Wall Street Journal (WSJ), tied their vote of support to increased restrictions on a drug that has already faced significant reduction of sales since 2007. Supporters of the drug who voted to keep Avandia on the market indicated after the vote that they only did so due to the lack, they said, of hard evidence with regard to potential harm.

They also said Avandia should be used only as a drug of last resort.

That’s good news for rival Actos, manufactured by Takeda Pharmaceuticals. Even though both Avandia and Actos carry black box warnings for fluid retention and the ensuing risk for heart failure, Avandia is thought to carry a greater risk for heart attack than its rival.

So much so, in fact, that the FDA directed the advisory panel to put that matter to a vote, pitting Read the rest of this entry »

Tags: Actos, Avandia, FDA, TIDE
Posted in Drugs/Medical, Emerging Issues | No Comments »

How Does the Avandia Settlement & TIDE Trial Affect Me?

May 18th, 2010. By Kristine B

If you’ve read the news lately, you may have heard that GlaxoSmithKline agreed to settle approximately 700 Avandia lawsuits for a reported $60 million. You may also have heard the calls to end the Avandia safety trial known as the TIDE trial. This may have you concerned about how these developments affect you, and rightfully so.

This week, Pleading Ignorance takes a look at how the Avandia settlement and the controversy over the Avandia and Actos TIDE trial may affect you.

Avandia Settlement

GlaxoSmithKline has reportedly agreed to settle 700 lawsuits for approximately $60 million. How this settlement affects you depends on where you are in the lawsuit process, if you are involved at all.

Obviously, if you’re one of the 700 lawsuits that have been settled, then your lawsuit is now done; you’ll receive your share of the settlement and no longer have to worry about the litigation.

If you are one of the remaining lawsuits (reported to number in the thousands), how this settlement affects you is less clear. Details about the settlement have been kept quiet. Based on how big businesses operate, my guess (this is just speculation here) is that GlaxoSmithKline has not admitted to any wrongdoing (something most businesses attach to their settlements). The settlement, however, shows that the drug maker is willing to sit down with plaintiff’s lawyers to negotiate, which could be a good thing for the remaining lawsuits.

That said, there is no guarantee that a settlement in those 700 initial lawsuits will translate into a settlement for the remaining lawsuits. It’s a good sign, but it’s no guarantee.

If you are considering contacting a lawyer but haven’t done so yet, the statute of limitations might be running out for you. One of the things that plays into how much time you have to file is whether or not your state follows a discovery rule. What’s that? Basically, it’s the point in time in which an individual would have likely been aware that a claim could be made against a defendant—or that a claim existed. In the case of Avandia, that would mean the point at which a person most likely knew they Read the rest of this entry »

Tags: Actos, Avandia, Avandia Settlement, Glaxo, GSK, TIDE
Posted in Drugs/Medical | 16 Comments »