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Are my oral type 2 diabetes medications heart-safe
Are My Oral Type 2 Diabetes Medications Heart-Safe?
After a two year inquiry into the safety of the type 2 diabetes drug rosiglitazone to determine if it increased the risk of heart problems, the U.S. Senate Finance Committee issued their findings highlighting potential health risks. The report was developed over the last two years by committee investigators who reviewed more than 250,000 pages of documents provided by the drug's manufacturer, the FDA, and several research institutes. The report can be found at
But what does that mean for you, the person dutifully taking what your doctor prescribes, and facing potential risks?
The American Heart Association issued the following guidelines after the Senate Committee's report.
• Consult with your physicians on any matters concerning risk factors you may
• In managing your diabetes, "focus on glycemic (blood sugar) control keeping
your HbA1c levels below 7.0 to reduce the risk of the 'microvascular' complications of diabetes, such as kidney failure, painful nerve problems, and decreased vision or even blindness."
• The AHA states that any diabetes management program should be founded on a
healthy diet and physical activity as well as healthful control of blood pressure and cholesterol and triglycerides. The AHA also adds: "An aspirin regimen should be used under the advice of a physician in patients who have known cardiovascular disease due to atherosclerosis."
• They then recommend that the type 2 oral medication metformin should
"generally be the first choice, particularly in obese patients." Other medications should be used if a person cannot get their A1Cs down to satisfactory levels.
• They go on to add that, "if a thiazolidinediones (TZD), such as pioglitazone or
rosiglitazone, is prescribed, it should not be used with an expectation of benefit in reducing the occurrence of heart attack or stroke, and the rationale for the choice of a TZD should be discussed with your physician. However, patients who have successfully achieved recommended HbA1c control on a TZD might consider remaining on their medication. If the treating physician and/or the patient are uncomfortable with using a TZD, another medication could be substituted. There is currently not enough data to support the choice of a specific TZD."
Type 2 Diabetes Drug Alert
A safety review notice was issued by the Food and Drug Administration (FDA) on February 23 about rosiglitazone, a drug used in several popularAvandia®, Avandamet®, and Avandaryl®—to increase the body's sensitivity to insulin. But it has been suspected of triggering potentially fatal cardiovascular problems for several years. In 2007, Steve E. Nissen, M.D., chairman of the department of cardiovascular medicine at the Cleveland Clinic published a
New England Journal of Medicine study that concluded "rosiglitazone was associated with a significant increase in the risk of myocardial infarction [heart attack]… patients and providers should consider the potential for serious adverse cardiovascular effects of treatment with rosiglitazone for type 2 diabetes." And the same year, the Food in Drug Administration issued a safety alert about a possible association between rosiglitazone and increased heart-related risk.
What was known then, according to the National Library of Medicine, was that the drug "may cause fluid retention that may lead to or worsen congestive heart failure (condition in which the heart is unable to pump enough blood to the other parts of the body)." They advise, in their Medline Plus online article, that "before you start to take rosiglitazone, tell your doctor if you have or have ever had congestive heart failure, especially if your heart failure is so severe that you must limit your activity and are only comfortable when you are at rest or you must remain in a chair or bed. Also tell your doctor if you were born with a heart defect, and if you have or have ever had swelling of the arms, hands, feet, ankles, or lower legs; heart disease, high blood pressure; coronary artery disease (narrowing of the blood vessels that lead to the heart); a heart attack; an irregular heartbeat; or high cholesterol or fats in the blood. Your doctor may tell you not to take rosiglitazone or may monitor you carefully during your treatment."
"If you develop congestive heart failure or other heart problems, you may experience certain symptoms. Tell your doctor immediately if you have any of the following symptoms, especially when you first start taking rosiglitazone or after your dose is increased: large weight gain in a short period of time; shortness of breath; swelling of the arms, hands, feet, ankles, or lower legs; swelling or pain in the stomach; waking up short of breath during the night; the need to sleep with extra pillows in order to breathe while lying down; frequent dry cough; or increased tiredness."
Now that the FDA has issued another notice of a safety review, people are feeling increased concern about taking rosiglitazone. This is what is current as of the last week of February 2010: The drug has not been pulled off the shelves. The FDA is currently reviewing scientific information that they received in August of 2009 from RECORD, a large, long-term study on the possible heart-attack related risks of rosiglitazone. The review will be completed in July of this year.
The FDA's current advice for anyone taking the drug is:
• Don't stop taking your medication without talking with your health care
• Discuss any questions or concerns you have about rosiglitazone with your health
• Read the Medication Guide that comes with each rosiglitazone prescription to
better understand the risks and benefits of your medication.
• Report any side effects with rosiglitazone to FDA's MedWatch program either
online, by regular mail, by fax, or by phone.
Regular Mail: Use postage-paid, pre-addressed FDA form 3500
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MEDICAL DRUG INTERACTIONS WITH STREET DRUGS A resource by and for drug users Compiled by Julie Klems, NEED (Needle Exchange Emergency Distribution, Berkeley, CA) This copy is made available for reference. The original is in zine format and can be purchased by contacting Julie at the address given in the booklet. Editorial Note: No clinical studies have ever been done on the interactions