From Pharmacy Drug Guide
Avandia® (rosiglitazone) is an anti-diabetic prescription drug used as part of an overall treatment plan for patients with type 2 diabetes mellitus. Manufactured by GlaxoSmithKline, Avandia® is classified as a thiazolidinedione. These types of drugs lower insulin resistance in the body.
Common side effects of Avandia® include headache, back pain, throat soreness and cold-like symptoms. Avandia® can cause patients to retain fluids, which can cause congestive heart failure. The drug is particularly dangerous for those with history of heart disease.
|Brand name for||Rosiglitazone|
|Uses||Oral anti-diabetic agent used in the treatment of Type 2 Diabetes. Improves glycemic control by increasing increasing insulin sensitivity and reducing circulating insulin levels|
|Common side effects||Headache, cold symptoms, sore throat, back pain, painful or irregular menstrual periods|
|Who should not take Avandia||Those who have heart disease|
|Severe side effects||Loss of appetite, nausea, vomiting, dark urine, yellowing of the skin or eyes, blurred vision, vision loss, difficulty seeing colors or in the dark, pale skin, dizziness, facial swelling, difficulty swallowing or breathing, hives, itching, fever, blisters|
|Suspected adverse reactions||Contact GlaxoSmithKline at 1-888-825-5249 or the FDA at 1-800-FDA-1088|
|Disclaimer||The information provided by PharmacyDrugGuide is not a substitute for professional medical advice, diagnosis, or treatment. Do not take any action based on the information on this page without consulting a physician.|
Common Avandia Side Effects
After study in clinical trials, Avandia® side effects were documented in groups of people taking the drug and compared to those on a placebo. Based on these clinical trials, the most common side effects experienced when taking Avandia® are:
- Upper respiratory infections
- Upper and lower extremity bone fractures in women
- Weight gain
- Back pain
- Hypoglycemia (low blood sugar)
Among women of childbearing years, Avandia® can increase the likelihood of becoming pregnant. This is even true for women who do not ovulate regularly.
Avandia® can also interact with other drugs and nutritional supplements, including medications taken for high blood pressure, high cholesterol, or diabetes. It can also adversely affect patients with liver or eye diseases.
About Drug Side Effects
Avandia Allergic Reactions
Serious allergic reactions to Avandia® are possible, but not likely. Symptoms of an allergic reaction may include: rash, itching, swelling, dizziness, and difficulty breathing. Patients may experience an allergic reaction to rosiglitazone, the active ingredient in Avandia®, or to any of the inactive substances used in the formulation of the diabetes drug.
Avandia Warnings and Precautions
An FDA advisory was issued in 2007, stating that Avandia® may cause or worsen heart failure. The advisory warns that patients experiencing any degree of poor heart pumping ability, shortness of breath, or edema should not be prescribed Avandia®.
The FDA met to discuss Avandia® on July 13 and 14 of 2010 in light of two more studies indicating that the drug raises the risk of heart attacks, strokes and cardiovascular-related death. Results from one of the studies, published online by the Journal of the American Medical Association, examined side effects experienced by 230,000 Medicare recipients who were prescribed either Avandia® or Actos®. The second study, published in the Archives of Internal Medicine, concluded that Avandia® greatly raises the risk of heart attacks and cardiovascular death. The FDA panel, while admitting they had concerns about Avandia's safety, ultimately voted to recommended the drug stay on the market. Twelve members of the 33-person panel voted to pull Avandia.
$1 billion of GlaxoSmithKline's annual worldwide sales have been attributed to Avandia®, approximately half of which were in the United States. Glaxo's representatives claimed that the studies were flawed, and that the trials do not indicate an increased risk of heart attack, stroke or death due to Avandia®.
On Thursday, September 23, 2010, the FDA announced that Avandia® would be restricted to Type 2 diabetes patients whose condition could not be controlled with any other diabetes medications. The FDA also ordered Glaxo Smith Kline (GSK) to convene an independent group of scientists to review the original Avandia® clinical trial for bias.