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FDA Restricts Access to Diabetes Drug Avandia

FDA Restricts Access to Diabetes Drug Avandia

The diabetes drug Avandia has been pulled from the European market and the U.S. Food and Drug Administration (FDA) has placed significant restrictions on its use in the U.S., citing increased risk of heart attack associated with the drug.

Avandia, the brand name for rosiglitazone, is a product of GlaxoSmithKline and is prescribed for the treatment of type 2 diabetes (non-insulin-dependent). It works to control blood sugar levels by making the cells of the body more sensitive to the action of insulin.

Patients in the U.S. will still be able to get Avandia if they cannot control their blood sugar with the use of other medicines, something that will need to be documented by physicians.

The oral medication was approved in 1999 and quickly became a top-selling prescription for diabetes, generating $3 billion a year, but sales slowed significantly since 2007 when a study linked the drug to risk of heart attack.

The FDA issued a statement that read, in part:

The U.S. Food and Drug Administration today announced that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with Type 2 diabetes who cannot control their diabetes on other medications. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.

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

Rosiglitazone also is available in combination with other diabetes medications, metformin under the brand name Avandamet or glimepiride under the brand name Avandaryl.

The FDA will require that GSK develop a restricted access program for Avandia under a risk evaluation and mitigation strategy, or REMS. Under the REMS, Avandia will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take Actos (pioglitazone), the only other drug in this class. Current users of Avandia who are benefiting from the drug will be able to continue using the medication if they choose to do so.

Doctors will have to attest to and document their patients’ eligibility; patients will have to review statements describing the cardiovascular safety concerns associated with this drug and acknowledge they understand the risks. The agency anticipates that the REMS will limit use of Avandia significantly.

“Allowing Avandia to remain on the market, but under restrictions, is an appropriate response, given the significant safety concerns and the scientific uncertainty still remaining about this drug,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

 

GlaxoSmithKline’s Chief Medical Officer, Ellen Strahlman, issued a statement a statement that said, in part:

Regulatory authorities in Europe and the US have been reviewing the efficacy and safety of Avandia. This week, they made decisions that will affect all patients in Europe and the US who are currently taking Avandia, Avandamet, Avaglim or Avandaryl, and so I wanted to take this opportunity to talk to you directly.

The European Medicines Agency has informed GSK that it is suspending the marketing authorisation for all rosiglitazone-containing products in the European Union, and this includes Avandia, Avandamet and Avaglim. The EMA is the regulatory agency responsible for deciding which medicines should be available for doctors in Europe to prescribe for their patients. And as a result of this decision, physicians will no longer be able to prescribe these medications.

The US Food and Drug Administration has also been reviewing the safety of Avandia. They’ve directed that GSK revise the label for Avandia, Avandamet and Avandaryl to include additional warnings and precautions. In addition, the FDA has also determined that GSK should implement a Risk Evaluation and Mitigation Strategy programme for the medicine, which would include restricting physician prescribing of the medicine to a named patient basis.

Again if you are a patient with Diabetes taking any of these medicines, do not stop taking your medication, but please contact your healthcare professional at the earliest opportunity to discuss the possible impact on your treatment.

Our primary concern are our patients with type 2 diabetes. GSK is working closely with the regulatory authorities and healthcare professionals to implement the changes. And we are making every effort to ensure that physicians and other healthcare professionals have all the information they need to help them understand how this affects their patients and what they should do next.

Regarding Avandia, you may also be aware that there has recently been a rigorous scientific debate about the medicine, which has resulted in a divergence of scientific opinion about its possible benefits and risks.

As a company, we believe that Avandia has helped millions of people manage their diabetes, and that it is a safe and effective treatment option when used appropriately.

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25 comments

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5:56AM PDT on Nov 2, 2010


chloromycetin Chloramphenicol works by preventing bacteria from producing proteins that are essential to them. Without these proteins the bacteria cannot grow, replicate and increase in numbers. http://www.sundrugstore.com/chloromycetin-c-23_144.html

5:55AM PDT on Nov 2, 2010


generic avandia Therefore, Avandia should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. • The coadministration of Avandia and insulin is not recommended. • The use of Avandia with nitrates is not recommended

3:00PM PDT on Oct 3, 2010

This was prescribed to my mother, a couple of years before her death, along with several other drugs. The one thing ALL her meds had in common was that each one of them should NOT be taken by people with liver or kidney problems. For the last 20 years she'd been living with one kidney operating at about 30%, and the other one functioning at 17%. All of her doctors KNEW this... yet they prescribed 5 separate drugs - this one included - and even though she took it for only a short length of time, she died. What she'd been prescribed was a cocktail of drugs, each one detrimental to her kidneys, but no one seemed to care. Avandia was probably the straw that broke the camel's back, even though she took it for less than 6 months.

8:50AM PDT on Oct 2, 2010

When you read the side effects of any drug, you have to be desparate to take it. I was on five Rx drugs and had problems with high blood pressure (after being normal for prior years,) leg cramps, and high chlorestoral (also after being normal for prior years.)
Stopped taking all of them. Will see what the doctor says when I go later this month.
I do watch my diet, take vitamins, and only take one otc allergy pill when I'm desperate.
By the way, antihistamine allergy pills raise your blood pressure.

4:37PM PDT on Sep 26, 2010

I read about this in the paper,,, what is not mentioned here, is that approximately 47,000 people died from side effects of this drug ... why are they just getting away with killing off 47,000 people while the FDA stands by with their finger up their butt.
that is one hell of a lot of innocent people dead from this drug, and I would like to know if anyone is doing anything about these killers? And if not, why not? Perhaps because the drug co's own our government.

12:25PM PDT on Sep 25, 2010

Big pharma says pass the drug, they do. Then the lab rats (you) report back that there are problems with it. Big pharma says - only in dire situations can you use our drug because of all the other stuff it causes. Treadmill anyone?

8:40AM PDT on Sep 25, 2010

Thank you for this post

1:37AM PDT on Sep 25, 2010

Thanks.

8:31PM PDT on Sep 24, 2010

Thanks for the article.

12:47PM PDT on Sep 24, 2010

noted

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