The use of diabetes medication, Avandia (rosiglitazone) is to be significantly restricted to patients with diabetes Type 2 who are unable to control their diabetes on other drugs, the Food and Drug Administration (FDA) has announced. FDA officials say this is after evaluating data which links Avandia to a higher risk of stroke and cardiovascular events, such as heart attack.
FDA Commissioner Margaret A. Hamburg, M.D., said:
The FDA is taking this action today to protect patients, after a careful effort to weigh benefits and risks. We are seeking to strike the right balance to support clinical care.
Rosiglitazone can be taken as a stand-alone drug (Avandia) and in combination with metformin (Avandamet) or with glimepiride (Avandaryl).
Avandia, a TZD (thiazolidinedione), should be used along with exercise and diet to improve blood sugar (glucose) control in individuals with Type 2 diabetes.
GlaxoSmikline, the makers and sellers of Avandia, will now have to develop a restricted access program for the drug under a Risk Evaluation and Mitigation Strategy (REMS).
Under the REMS, the only diabetes Type 2 patients who will be able take Avandia will be those who do not respond to other drugs and cannot take pioglitazone (Actos), the only other medication in this class.
Patients who are currently taking Avandia and benefiting from them will be able to continue with the same medication if they so wish, the FDA wrote today.
Doctors will be required to attest to and document whether a patient is eligible for Avandia treatment. The patient will be required to be shown statements which clearly describe the cardiovascular/stroke concerns linked with this medication, and acknowledge that they are aware of the risks. This will probably limit Avandia’s use considerably, the FDA anticipates.
Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, said:
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.
GlaxoSmithKline has been told to assemble a group of independent scientists to examine key aspects of RECORD, the company’s clinical trial which studied the cardiovascular safety of Avandia compared to standard diabetes medications.
Questions arose regarding potential bias in the detection of cardiovascular events while the FDA reviewed the RECORD study, the FDA wrote. The Agency insists on an independent review so that the validity of the findings can be cleared up.
TIDE, a trial which compares Avandia to Actos and standard diabetes medications has been halted by the FDA – all regulatory deadlines on this trial have been withdrawn.
When the independent examination of the RECORD trial is completed and delivered to the FDA, the Agency may take additional actions.
- Message from Dr Ellen Strahlman, Chief Medical Officer, GlaxoSmithKline
Source: Food and Drug Administration
Written by Christian Nordqvist