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Access to Rosiglitazone to Be Restricted, Says FDA
Physicians, Patients Required to Enroll in REMS Program
By News Staff
Cardiovascular Risks Prompt Restrictions
The FDA, however, did not remove the product, although the agency did announce in September 2010 that it planned to restrict the use of rosiglitazone medications. As part of that announcement, the FDA said it would require manufacturer GlaxoSmithKline to develop a restricted access program for the affected medications:
- rosiglitazone, which is marketed as Avandia;
- rosiglitazone and metformin, which is marketed as Avandamet; and
- rosiglitazone and glimepiride, which is marketed as Avandaryl.
REMS Lists Prescribing Limitations
- those already being successfully treated with these medications; and
- those whose blood sugar cannot be controlled with other diabetes medications and who, after consulting with their health care professional, do not wish to use pioglitazone-containing medicines.
- Physicians should determine whether their patients are appropriate candidates to receive treatment with rosiglitazone-containing medications based on the risks and benefits of the medications versus those of other therapies.
- Physicians are required to review the prescriber overview and prescribing information, including the medication guide, and complete and sign the prescriber enrollment form included in the REMS document.
- Physicians must provide a copy of the medication guide for the prescribed medicine and review it with the patient or caregiver.
- Physicians must complete and sign a patient enrollment form so that the patient may begin or continue to receive rosiglitazone medications.
- If a patient who has been taking a rosiglitazone medication is hospitalized, the patient must be enrolled to continue receiving the drug; however, the patient's health care professional in the hospital is not required to be enrolled.
- Report any adverse events involving rosiglitazone medications to the FDA's MedWatch program.