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glimepiride/rosiglitazone FDA Alerts

The FDA Alert(s) below may be specifically about glimepiride/rosiglitazone or relate to a group or class of drugs which include glimepiride/rosiglitazone.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for glimepiride/rosiglitazone

Rosiglitazone-containing Diabetes Medicines: Drug Safety Communication - FDA Eliminates the Risk Evaluation and Mitigation Strategy (REMS)

Dec 16, 2015

Audience: Family Care, Endocrinology, Cardiology

ISSUE: FDA is eliminating the Risk Evaluation and Mitigation Strategy (REMS) for rosiglitazone-containing type 2 diabetes medicines, which are approved as Avandia, Avandamet, Avandaryl, and generics. The REMS is no longer necessary to ensure that the benefits of rosiglitazone medicines outweigh their risks.

In 2013, FDA required removal of the prescribing and dispensing restrictions for rosiglitazone medicines after determining that data did not demonstrate an increased risk of heart attack with rosiglitazone medicines compared to the standard type 2 diabetes medicines metformin and sulfonylurea. FDA also required the drug manufacturers to provide educational training to health care professionals about the current state of knowledge regarding the heart risks of rosiglitazone medicines. Manufacturers have since fulfilled these requirements.

FDA has continued monitoring these medicines and identified no new pertinent safety information. FDA will update the public if any new information becomes available.

BACKGROUND: Type 2 diabetes is a disease that can lead to serious complications such as kidney failure, blindness, and premature death. Rosiglitazone can be used along with diet and exercise to control blood sugar in adults with the disease.

RECOMMENDATION: The REMS is no longer necessary to ensure that the benefits of rosiglitazone medicines outweigh their risks.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[12/16/2015 - Drug Safety Communication - FDA]
 

Rosiglitazone-containing Diabetes Medicines: Drug Safety Communication - Removal of Some Prescribing and Dispensing Restrictions

Nov 25, 2013

Audience: Family Care, Endocrinology, Cardiology

including Avandia, Avandamet, Avandaryl, and generics

 

[Posted 11/25/2013]

ISSUE: FDA has determined that recent data for rosiglitazone-containing drugs, such as Avandia, Avandamet, Avandaryl, and generics, do not show an increased risk of heart attack compared to the standard type 2 diabetes medicines metformin and sulfonylurea. As a result, FDA is requiring removal of the prescribing and dispensing restrictions for rosiglitazone medicines that were put in place in 2010. This decision is based on FDA review of data from a large, long-term clinical trial and is supported by a comprehensive, outside, expert re-evaluation of the data conducted by the Duke Clinical Research Institute (DCRI). 

Previous data from a large, combined analysis of mostly short-term, randomized clinical trials of rosiglitazone had suggested an elevated risk of heart attack, so FDA required a Risk Evaluation and Mitigation Strategy (REMS), called the Rosiglitazone REMS program. The Rosiglitazone REMS program restricted the use of rosiglitazone medicines to help ensure that their benefits outweighed the risks. 

Although some scientific uncertainty about the cardiovascular safety of rosiglitazone medicines still remains, in light of the new re-evaluation of the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial, FDAs concern is substantially reduced and the rosiglitazone REMS program requirements will be modified. FDA is also requiring revisions to the rosiglitazone prescribing information and the patient Medication Guide to include this new information.

Refer to the Drug Safety Communication for more details.

BACKGROUND: Rosiglitazone is a treatment option that can improve blood sugar control in some patients with type 2 diabetes.

RECOMMENDATION: Patients with type 2 diabetes should continue to work closely with their health care professionals to determine treatment options that are most appropriate. Health care professionals, pharmacies, and patients will no longer be required to enroll in the rosiglitazone REMS program to be able to prescribe, dispense, or receive rosiglitazone medicines. As part of the REMS, sponsors will ensure that health care professionals who are likely to prescribe rosiglitazone medicines are provided training based on the current state of knowledge concerning the cardiovascular risk of rosiglitazone medicines. Manufacturers will also send Dear Healthcare Provider and Dear Professional Society letters to educate prescribers about the new information.

[11/25/2013 - Drug Safety Communication - FDA]

Avandia (rosiglitazone): REMS - Risk of Cardiovascular Events

Nov 4, 2011

Audience: Endocrinology, Cardiology

includes Avandia, Avandamet, and Avandaryl

 

[UPDATED 11/04/2011] Healthcare providers must enroll in the Avandia-Rosiglitazone Medicines Access Program if they wish to prescribe rosiglitazone medicines to outpatients or patients in long-term care facilities after November 18, 2011.

[UPDATED 05/18/2011] FDA notified healthcare professionals and the public of new restrictions to the prescribing and use of rosiglitazone-containing medicines. These medicines to treat type II diabetes are sold under the names Avandia, Avandamet, and Avandaryl. Healthcare providers and patients must enroll in a special program in order to prescribe and receive these drugs.

FDA has modified the REMS for Avandamet and Avandaryl because previously, the REMS consisted of only a Medication Guide. The REMS, which now includes a restricted access and distribution program, applies to all three rosiglitazone products.

 

[UPDATED 02/04/2011] FDA notified healthcare professionals and patients that information on the cardiovascular risks (including heart attack) of rosiglitazone has been added to the physician labeling and patient Medication Guide. This information was first announced by FDA on September 23, 2010 as part of new restrictions for prescribing and use of this drug.

Rosiglitazone is sold as a single-ingredient product under the brand name Avandia. Rosiglitazone is also sold as a combination product under the brand name Avandamet (contains rosiglitazone and metformin) and under the brand name Avandaryl (contains rosiglitazone and glimepiride).

In addition to describing the cardiovascular risks, the drug labels have been revised to state that rosiglitazone and rosiglitazone-containing medicines should only be used:

  • In patients already being treated with these medicines
  • In patients whose blood sugar cannot be controlled with other anti-diabetic medicines and who, after consulting with their healthcare professional, do not wish to use pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or Duetact).

 

[Posted 09/23/2010]

ISSUE: FDA notified healthcare professionals and patients 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.

BACKGROUND: Avandia is in a class of drugs known as thiazolidinediones, or TZDs. It is intended to be used in conjunction with diet and exercise to improve glucose (blood sugar) control in patients with Type 2 diabetes mellitus. Rosiglitazone also is available in combination with other diabetes medications, metformin under the brand name Avandamet or glimepiride under the brand name Avandaryl.

RECOMMENDATION: 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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

 

[11/04/2011 - Drug Safety Communication - FDA]
[05/18/2011 - Drug Safety Communication - FDA]
[02/03/2011 - Drug Safety Communication - FDA]
[02/03/2011 - Prescribing Information/Medication Guide - GSK]

[09/23/2010 - News Release - FDA]
[09/23/2010 - Q&As - FDA]
[09/23/2010 - Avandia Related Information - FDA]
 

Avandia (rosiglitazone): REMS - Risk of Cardiovascular Events

May 18, 2011

Audience: Endocrinology, Cardiology

includes Avandia, Avandamet, and Avandaryl

[UPDATED 05/18/2011] FDA notified healthcare professionals and the public of new restrictions to the prescribing and use of rosiglitazone-containing medicines. These medicines to treat type II diabetes are sold under the names Avandia, Avandamet, and Avandaryl. Healthcare providers and patients must enroll in a special program in order to prescribe and receive these drugs.

FDA has modified the REMS for Avandamet and Avandaryl because previously, the REMS consisted of only a Medication Guide. The REMS, which now includes a restricted access and distribution program, applies to all three rosiglitazone products.

[UPDATED 02/04/2011] FDA notified healthcare professionals and patients that information on the cardiovascular risks (including heart attack) of rosiglitazone has been added to the physician labeling and patient Medication Guide. This information was first announced by FDA on September 23, 2010 as part of new restrictions for prescribing and use of this drug.

Rosiglitazone is sold as a single-ingredient product under the brand name Avandia. Rosiglitazone is also sold as a combination product under the brand name Avandamet (contains rosiglitazone and metformin) and under the brand name Avandaryl (contains rosiglitazone and glimepiride).

In addition to describing the cardiovascular risks, the drug labels have been revised to state that rosiglitazone and rosiglitazone-containing medicines should only be used:

  • In patients already being treated with these medicines
  • In patients whose blood sugar cannot be controlled with other anti-diabetic medicines and who, after consulting with their healthcare professional, do not wish to use pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or Duetact).

[Posted 09/23/2010]

ISSUE: FDA notified healthcare professionals and patients 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.

BACKGROUND: Avandia is in a class of drugs known as thiazolidinediones, or TZDs. It is intended to be used in conjunction with diet and exercise to improve glucose (blood sugar) control in patients with Type 2 diabetes mellitus. Rosiglitazone also is available in combination with other diabetes medications, metformin under the brand name Avandamet or glimepiride under the brand name Avandaryl.

RECOMMENDATION: 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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[05/18/2011 - Drug Safety Communication - FDA]
[02/03/2011 - Drug Safety Communication - FDA]
[02/03/2011 - Prescribing Information/Medication Guide - GSK]

[09/23/2010 - News Release - FDA]
[09/23/2010 - Q&As - FDA]
[09/23/2010 - Avandia Related Information - FDA]

Avandia (rosiglitazone): REMS - Risk of Cardiovascular Events

Feb 4, 2011

Audience: Endocrinology, Cardiology

[UPDATED 02/04/2011] FDA notified healthcare professionals and patients that information on the cardiovascular risks (including heart attack) of rosiglitazone has been added to the physician labeling and patient Medication Guide. This information was first announced by FDA on September 23, 2010 as part of new restrictions for prescribing and use of this drug.

Rosiglitazone is sold as a single-ingredient product under the brand name Avandia. Rosiglitazone is also sold as a combination product under the brand name Avandamet (contains rosiglitazone and metformin) and under the brand name Avandaryl (contains rosiglitazone and glimepiride).

In addition to describing the cardiovascular risks, the drug labels have been revised to state that rosiglitazone and rosiglitazone-containing medicines should only be used:

  • In patients already being treated with these medicines
  • In patients whose blood sugar cannot be controlled with other anti-diabetic medicines and who, after consulting with their healthcare professional, do not wish to use pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or Duetact).

 

[Posted 09/23/2010]

ISSUE: FDA notified healthcare professionals and patients 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.

BACKGROUND: Avandia is in a class of drugs known as thiazolidinediones, or TZDs. It is intended to be used in conjunction with diet and exercise to improve glucose (blood sugar) control in patients with Type 2 diabetes mellitus. Rosiglitazone also is available in combination with other diabetes medications, metformin under the brand name Avandamet or glimepiride under the brand name Avandaryl.

RECOMMENDATION: 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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

 

[02/03/2011 - Drug Safety Communication - FDA]
[02/03/2011 - Prescribing Information/Medication Guide - GSK]
 

[09/23/2010 - News Release - FDA]
[09/23/2010 - Q&As - FDA]
[09/23/2010 - Avandia Related Information - FDA]
 

    

Avandia (rosiglitazone): REMS - Risk of Cardiovascular Events

Sep 23, 2010

Audience: Endocrinology, Cardiology

[Posted 09/23/2010]

ISSUE: FDA notified healthcare professionals and patients 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.

BACKGROUND: Avandia is in a class of drugs known as thiazolidinediones, or TZDs. It is intended to be used in conjunction with diet and exercise to improve glucose (blood sugar) control in patients with Type 2 diabetes mellitus. Rosiglitazone also is available in combination with other diabetes medications, metformin under the brand name Avandamet or glimepiride under the brand name Avandaryl.

RECOMMENDATION: 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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

 

[09/23/2010 - News Release - FDA]
[09/23/2010 - Q&As - FDA]
[09/23/2010 - Avandia Related Information - FDA]
 

    

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