Diabetes Medication Avandia To Be Subjected To Further Restrictions

Avandia (rosiglitazone) is a diabetes medication used to treat type 2 diabetes. Other medications containing rosiglitazone plus other ingredients include Avandamet (rosiglitazone and metformin) and Avandaryl (rosiglitzone and glimepiride). Rosiglitazone is manufactured by GlaxoSmithKline. Between January, 2010 and October, 2010, about 460,500 patients filled a prescription for a medication containing rosiglitazone at retail pharmacies.

Concerns started to surface from data that suggested that medications containing rosiglitazone were associated with an elevated risk of heart attacks. As a result, the U.S. Food and Drug Administration (FDA) announced on September 23, 2010 that it would restrict use of rosiglitazone to patients with type 2 diabetes whose blood sugar level could not be controlled on other medications. Prescriptions for medications containing rosiglitazone fell by 50% from January, 2010 (235,500 patients) to about 119,000 in October, 2010.

The more recent restrictions apply to all medications containing rosiglitazone and restricts access to and distribution of rosiglitazone. Health care providers and their patients who take rosiglitazone-containing medications must enroll in a special program (“Avandia-Rosiglitazone Medicines Access Program”)  in order to prescribe and receive such medications (hospitalized patients who take rosiglitazone must be enrolled in the special program to continue to receive the medication but the hospital health care provider will not have to be enrolled in the program).  After November 18, 2011, medications containing rosiglitazone will no longer be available through retail pharmacies and participants in the special program will receive their medications by mail order and only through specially certified pharmacies that are participating in the program.

In light of the new restrictions and the special program involving rosiglitazone-containing medications, health care providers will need to determine which of their patients are appropriate candidates to participate in the special program based on an analysis of the risks and benefits of taking rosiglitazone versus other medications and therapies that may be available. The health care providers who enroll in the special program will need to provide and review certain information regarding rosiglitazone with each of their patients who they enroll in the special program. After November 18, 2011, GlaxoSmithKline will withdraw rosiglitazone from its current supply chain and will provide pharmacies with instructions on how to return those medications.

Source: FDA

If you presently take a medication containing rosiglitazone, you should talk with your prescribing health care provider regarding your continuing use of rosiglitazone, the risks and benefits to you in continuing to take rosiglitazone-containing medications, the alternatives that may be available to you and the risks and benefits of the alternatives, and about enrolling you (and your health care provider) in the special program for rosiglitazone.

If you or a loved one have been injured as a result of taking Avandia or another medication, visit our website to be connected with medical malpractice lawyers in your area who may be able to assist you with your medical malpractice claim or call us toll free 800-295-3959.

This entry was posted on Sunday, May 22nd, 2011 at 12:40 pm. Both comments and pings are currently closed.


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