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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