FDA keeps GSK diabetes drug on market but restricts its use

Posted September 23, 2010

— European health regulators have banned sales of the once-blockbuster diabetes drug Avandia because of evidence it raises the risk of heart attack, but doctors in the U.S. will be able to continue prescribing it with some significant restrictions.

In simultaneous news briefings, the European Medicines Agency and the U.S. Food and Drug Administration announced their decisions on the controversial drug. The European regulator said it would stop authorizing marketing of Avandia and said it would be removed from the market within the next few months.

Earlier this month, Britain’s drug regulator said an independent panel of experts concluded Avandia raised the risk of heart attacks and recommended it be pulled from the market.

GlaxoSmithKline (NYSE: GSK), which employs more than 4,000 people in the RTP area, has been under growing criticism for Avandia, which is used to treat Type 2 diabetes.

The FDA announced that new patients will be able to get a prescription for Avandia only if they can’t control their blood sugar with other medications. Doctors will have to document that their patients are eligible to receive the drug and have been briefed on its risks. FDA expects the restriction plan “will limit use of Avandia significantly.”

The FDA’s decision marks the second time in three years that the agency has decided to leave Avandia on the market, despite mounting pressure to recall the drug from outside medical experts, politicians and some of its own scientists.

The FDA first approved the drug in 1999 and it became the top-selling diabetes pill in the world. But use has plummeted since a 2007 analysis linked the drug to heart attack risks.

FDA’s critics have framed the Avandia decision as a key test of the agency’s Obama-appointed leadership, who vowed to bolster the agency’s regulatory stance after a series of drug safety problems under the previous administration.

“The FDA is taking this action today to protect patients, after a careful effort to weigh benefits and risks,” said FDA Commissioner Margaret Hamburg, “We are seeking to strike the right balance to support clinical care.”

The FDA’s latest decision on Avandia is likely to draw ire from safety advocates and lawmakers on Capitol Hill, though it essentially concurs with the opinion outside experts reached earlier this year.

In July, a 33-member panel of medical experts voted 20-12 to keep Avandia available in the U.S. Of the 20 who voted to keep it on the market, 10 said it should only be available on a limited basis. The FDA is not required to follow the group’s advice, though it often does.


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  • JustOneGodLessThanU Sep 24, 2010

    jrphill2, Avandia has been completely banned by the European Medicines Agency. The FDA wants to keep it for us as a last ditch effort.

    So, do you agree that the FDA should continue to restrict the use of drugs or not? And, why do you think Europe banned Avandia no one has access? For profit?...or because they want to protect the health of their people?

    And, whatsamatter?...don’t like Pink Floyd? ;-)

  • davidgnews Sep 23, 2010

    Anyone ever see all of those lawsuit solicitations regarding Avandia on WRAZ-50.2 (RTN) ?

  • animalluver Sep 23, 2010

    Really, those with diabetes really need to increase their risk. Having diabetes already increases the risk of heart disease. Those with diabetes are 2-4 times more likely to have heart problems. So with this drug it ups that to even higher. I suppose those who manage their diabetes well might be able to take the increased risk, but really who wants to risk that?
    True it is a matter of choice, but some doctors do not talk to their patients, telling them of the risk to them. They simply don't have the time, they are allotted 5-7 minutes per patient. I have never understood how in that amount of time one can properly diagnose anything. There are better ways to manage illnesses but that requires changing ones diet.

  • we_all_have_it_coming Sep 23, 2010

    Personal choice.

    Like smoking... you know what it does to you, right?

    Let people sign a waiver and take the drug en mass. If they drop dead - who cares.

  • IndependentAmerican Sep 23, 2010

    tb4unc: Yes, I do know how the FDA panels work. As I said, I work in the healthcare industry, just not for a pharmaceutical company. Each approved drug has a myriad of potential side effects, in this case one is increased risk of heart attacks. Other drugs also have that side effect, just not as high. The doctor and patient shoud be the ones to decide if that risk is worth the treatment. If the risk is way out of line, the FDA would not have left it on the market. This raises a whole new train of thought - what is 'out of line'. Another thread maybe.

  • IndependentAmerican Sep 23, 2010

    hereandnow99: You are obviously a democrat. I'm NOT advocating open access to all drugs. The FDA has a process to review drugs, flawed as it is. But they shouldn't be telling me I can't use it because I should try other approved options first. As for the tea party references: The state controlled media and other mis-informed folks think it's an anti-Obama/right wing/racist group. Not true. Remember this? "The Troubled Asset Relief Program, commonly referred to as TARP, is a program of the United States government to purchase assets and equity from financial institutions to strengthen its financial sector which was signed into law by U.S. President George W. Bush on October 3, 2008." (note the under Bush statement).
    The actual roots of the tea party may be obscure, but TARP was the fuel that brought it to a boil. It really isn't about Bush or Obama, rather about Wash. DC running amok with OUR government. This FDA decision falls into that same 'we are holier than though' attit

  • JustOneGodLessThanU Sep 23, 2010

    jrphill2, remove all safety rules from pharmaceuticals (like the Tea Party & "less gov't" folks advocate) and yes you CAN choose what drugs you take, how much & when. I hear ya...add in some Pink Floyd music and it certainly sounds like fun. Heck, even your kids could self medicate if there are no rules. ;-)

    Of course, there'd be no guarantee that you'd actually be getting the drug you think you're getting...much less in the potency that you expect.

    You seem to be advocating that everyone (or just you?) should have limitless prescription drug choice & access. Do you really think that people could handle that? If so, why not dump rules for every drug?... marijuana, cocaine, heroin, meth, etc.

  • lb27608 Sep 23, 2010

    jrphill2: "The qeustion is about choice. I no longer have the free choice to take Avandia because some bureaucrat thinks he knows better than me."

    If you knew anything about how these FDA panels work, you would know that it's not "some bureaucrat" making the decision. And yes, given the training that these people have, they probably DO know better than you. The FDA's charge is to minimize risk for the entire population, not for each individual person. The process isn't perfect and sometimes the FDA is a bit too strict, but I'll take that over an unregulated pharmaceutical industry any day.

    Plus, the drug isn't even coming off the market - your doctor can still prescribe it for you if you meet the criteria to take it and he/she decides that it's in your best interest to do so.

  • Ladybug Sep 23, 2010

    Diabetes Type 2 runs in our family but our doctor has sense enough not to perscribe it.

  • Mugu Sep 23, 2010

    Wilford Brimley does not approve.