On September 23, 2010, the FDA ( Food and Drug Administration ) announced that it would restrict access to Rosiglitazone ( Avandia ) through use of a Risk Evaluation and Mitigation Strategy, or REMS.
Under the Food and Drug Administration Amendments Act of 2007, FDA can require a drug sponsor to issue a REMS to impose certain restrictions to assure that the benefits of a drug continue to outweigh its risks.
Rosiglitazone is a thiazolidinedione anti-diabetic agent indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Rosiglitazone is also available in combination with other diabetes medications. Rosiglitazone combined with Metformin is sold under the brand name Avandamet. Rosiglitazone combined with Glimepiride is sold under the brand name Avandaryl.
For several years, there have been concerns about the potential for a cardiovascular ischemic risk associated with Rosiglitazone. Cardiovascular ischemia is a deficiency of blood flow to tissue usually due to constriction or an obstruction of a blood vessel. These concerns have arisen from multiple data sources, including various meta-analyses and observational studies.
Although the data that show a cardiovascular risk for Rosiglitazone have their limitations, no data source exists to refute them. As such, FDA takes the potential cardiovascular safety concerns with Rosiglitazone seriously. FDA has decided, in the interest of patient health, to require additional safeguards and restrictions for the use of this drug through a Risk Evaluation and Mitigation Strategy ( REMS ). This REMS will be designed to assure that the benefits of Rosiglitazone continue to outweigh its risks.
Patients, currently taking Rosiglitazone, should continue taking the medication and consult healthcare professional. Health care professional may choose an alternative medication without the concern for cardiovascular ischemia.
FDA's decision allows current users of Rosiglitazone to continue using the medication if they appear to be benefiting from it and they acknowledge they understand these risks. However, because of concerns for cardiovascular ischemia, physicians may want to consider switching patients to a different medication.
Once the REMS is in place, Rosiglitazone will be available to patients not already taking it only if they are unable to achieve glycemic control on other medications and decide not to take Pioglitazone for medical reasons. Furthermore, healthcare professionals will have to attest to and document their patient's eligibility if they believe that their patient is a candidate for Rosiglitazone.
Rosiglitazone can effectively control blood sugar, which prevents short-term complications of diabetes and is a reliable marker for lessening long-term complications.
The data underlying the cardiovascular ischemic risks of Rosiglitazone are concerning, but they are not definitive. For those patients who cannot effectively control their blood sugar using alternative medications, the benefits of Rosiglitazone may exceed these risks.
In addition, there are also individuals currently taking Rosiglitazone who, with full knowledge of the potential risk and in consultation with their healthcare providers, may wish to remain on the drug rather than revise their treatment. FDA's action permits them to do so.
The European Medicines Agency ( EMA ) has decided to suspend marketing of Rosiglitazone. Patients in Europe will be transitioning to alternative medications, and the drug may be brought back into use if additional information becomes available.
There is substantial agreement between EMA and FDA on the interpretation of the scientific data and the assessment of risks. Both agencies have significant concerns about the risk for cardiovascular ischemia. Each agency is managing this risk of Rosiglitazone with what it believes is the best risk management tool it has for this circumstance. Those tools are different and reflect the different regulatory environments in Europe and the United States.
Europe has suspended the product while awaiting additional data to help further clarify the benefit-to-risk profile of Rosiglitazone. FDA has markedly restricted patient access to the product and introduced new detailed patient information procedures while it awaits additional information to help further clarify the benefit-to-risk profile of the product.
Source: FDA, 2010