[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).
For more information visit the FDA website at: [Web] and [Web].
[Posted 09/23/2010] ISSUE: FDA notified healthcare professionals and patients that it will significantly restrict the use of the diabetes drug rosiglitazone (Avandia) 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 rosiglitazone
BACKGROUND: Rosiglitazone 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 rosiglitazone under a risk evaluation and mitigation strategy, or REMS. Under the REMS, rosiglitazone will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take pioglitazone (Actos), the only other drug in this class. Current users of rosiglitazone 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 rosiglitazone significantly. For more information visit the FDA website at: [Web] and [Web].
[Posted 02/22/2010] FDA notified healthcare professional and patients that it is reviewing the primary data from a large, long-term clinical study, RECORD, on possible cardiovascular risks with the diabetes drug, rosiglitazone (Avandia). In addition to the clinical trial, a number of observational studies of the cardiovascular safety of rosiglitazone have been published and FDA has been reviewing these on an ongoing basis.
These reviews are ongoing and no new conclusions or recommendations about the use of rosiglitazone in the treatment of type 2 diabetes have been made at this time. Once FDA completes its review of the data from the RECORD study, the agency will present the totality of new and existing cardiovascular safety data on rosiglitazone at a public meeting in July 2010. The Agency will provide an updated assessment of the risks and benefits of rosiglitazone in the treatment of type 2 diabetes.
FDA recommends that healthcare professionals follow the recommendations in the drug label when prescribing rosiglitazone. This includes a Boxed Warning. Patients should continue taking rosiglitazone unless told by their healthcare professional to stop. Patients who are concerned about the possible risks associated with using rosiglitazone should talk to their healthcare professional. For more information visit the FDA website at: [Web] and [Web].
REMS:
FDA approved a REMS for rosiglitazone to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of rosiglitazone and consists of the following: medication guide, elements to assure safe use, communication plan, and implementation system. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).
Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take this medicine with or without food. Take your medicine at the same time each day. Do not take more often than directed. Do not stop taking except on your doctor's advice.
A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Visit your doctor or health care professional for regular checks on your progress.
Your health care professional will have to check blood tests regularly to assess the effect of this medication on your liver.
Learn how to check your blood sugar. Learn the symptoms of low and high blood sugar and how to manage them.
If you have low blood sugar, eat or drink something that has sugar. Make sure others know to get medical help quickly if you have serious symptoms of low blood sugar, like if you become unconscious or have a seizure.
This medicine may increase your risk of having some heart problems. Get medical help right away if you have any chest pain or tightness, or pain that radiates to the jaw or down the arm, and shortness of breath. These may be signs of a serious medical condition.
This medicine may cause ovulation in premenopausal women who do not have regular monthly periods. This may increase your chances of becoming pregnant. You should not take this medicine if you become pregnant or think you may be pregnant. Talk with your doctor or health care professional about your birth control options while taking this medicine. Contact your doctor or health care professional right away if think you are pregnant.
If you need surgery or if you will need a procedure with contrast drugs, tell your doctor or health care professional that you are taking this medicine.
Wear a medical identification bracelet or chain to say you have diabetes, and carry a card that lists all your medications.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children
Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep container tightly closed and protect from light. Throw away any unused medicine after the expiration date.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
