Diabetes drug risk - what Labs rat cannot tell us.
Posted: Fri Oct 01, 2010 4:42 pm
Updated 12:02 PM Sep 27, 2010SINGAPORE - The Health Sciences Authority (HSA) has announced that it will significantly limit the use of the diabetes drug, Avandia, in order to minimise the potential cardiovascular risks associated with the medicine.
It said Avandia, made by British firm GlaxoSmithKline, and also known by its generic name rosiglitazone, will be limited to selected patients who are unable to effectively control their blood sugar with the use of other medications.
The decision was based on the assessment conducted by HSA together with its Pharmacovigilance Advisory Committee and a panel of diabetes and heart disease experts.
The drug has been licensed in Singapore since 2000 for blood sugar control in patients with type 2 diabetes in addition to diet and exercise.
The HSA's announcement comes a day after the United States Food and Drug Administration (FDA) said it would significantly restrict the use of rosiglitazone to patients who cannot control their diabetes with other medications.
In a simultaneous news briefing, the European Medicines Agency announced that it would suspend the marketing of Avandia and ban its sale within the next few months.
It also decided to halt the sale of Glaxo's other diabetes drugs, Avandamet and Avaglim, as they too contain rosiglitazone.
Avandia has long been associated with an increased risk of heart attack and stroke. An FDA study in 2007 linking the medication to serious health concerns prompted the authorities to slap a warning on it.
The HSA said that, following its review, it has assessed that there is a small possible increased risk of heart attacks associated with rosiglitazone. "However, for a group of patients who cannot effectively control their blood sugar using alternative medications, the benefits of rosiglitazone may outweigh these risks," it added.
To enhance safer use of the drug, the HSA will implement a risk management plan to strictly disallow the use of the drug in patients with heart problems.
Patients who have been prescribed medication with rosiglitazone are advised to consult their doctors if they have concerns about their drug therapy.
The HSA said patients should not stop taking their medications unless advised by their doctors.
http://www.todayonline.com/Singapore/ED ... 000069/HD-
It said Avandia, made by British firm GlaxoSmithKline, and also known by its generic name rosiglitazone, will be limited to selected patients who are unable to effectively control their blood sugar with the use of other medications.
The decision was based on the assessment conducted by HSA together with its Pharmacovigilance Advisory Committee and a panel of diabetes and heart disease experts.
The drug has been licensed in Singapore since 2000 for blood sugar control in patients with type 2 diabetes in addition to diet and exercise.
The HSA's announcement comes a day after the United States Food and Drug Administration (FDA) said it would significantly restrict the use of rosiglitazone to patients who cannot control their diabetes with other medications.
In a simultaneous news briefing, the European Medicines Agency announced that it would suspend the marketing of Avandia and ban its sale within the next few months.
It also decided to halt the sale of Glaxo's other diabetes drugs, Avandamet and Avaglim, as they too contain rosiglitazone.
Avandia has long been associated with an increased risk of heart attack and stroke. An FDA study in 2007 linking the medication to serious health concerns prompted the authorities to slap a warning on it.
The HSA said that, following its review, it has assessed that there is a small possible increased risk of heart attacks associated with rosiglitazone. "However, for a group of patients who cannot effectively control their blood sugar using alternative medications, the benefits of rosiglitazone may outweigh these risks," it added.
To enhance safer use of the drug, the HSA will implement a risk management plan to strictly disallow the use of the drug in patients with heart problems.
Patients who have been prescribed medication with rosiglitazone are advised to consult their doctors if they have concerns about their drug therapy.
The HSA said patients should not stop taking their medications unless advised by their doctors.
http://www.todayonline.com/Singapore/ED ... 000069/HD-
