Avandia Side Effects

Studies indicate significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia

Avandia® (rosiglitazone), manufactured by the pharmaceutical company GlaxoSmithKline, was approved for treatment of type 2 diabetes in 1999. The disease affects nearly 20 million Americans and is a leading cause of coronary heart disease, blindness, kidney failure and limb amputation among patients. The FDA has monitored several heart-related adverse events related to the drug use since its approval. These conditions include fluid retention, edema and congestive heart failure. The FDA has updated the product labeling on multiple occasions to reflect new data as it becomes available. The 2006 labeling change included a new warning about the potential for an increase in heart attacks and heart-related chest pain in some patients using Avandia.

In May 2007, the FDA informed healthcare professionals of a potential safety issue related to the use of Avandia. Data derived from controlled clinical studies indicated a significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia. The safety alert went on to say that there were some unpublished trials that seemed to provide contradictory evidence but the FDA still encouraged patients taking Avandia to speak with their healthcare professionals regarding risk factors.

An on-going analysis of safety data for the treatment of type 2 diabetes mellitus using Avandia showed differing rates of cardiovascular events including heart attack or heart-related adverse events, some of which were fatal. The clinical studies reviewed to date vary with respect to their populations, treatment regimens, and length of follow-up, but the data is enough to indicate a need for careful consideration by prescribers before making treatment decisions for patients with diabetes mellitus.

Are You Taking Avandia?

If you are presently taking Avandia under a doctor's prescription and supervision, do not stop taking Avandia without first talking to your doctor about this information. You should discuss the best individualized treatment plan for your diabetes and other medical conditions. Your doctor may be able to suggest alternative medications that don't increase your risk for heart attack or other adverse heart-related events.

Injured by Avandia?

If you have or a family member has been injured or suffered serious side effects from the drug Avandia, you may be entitled to compensation from those responsible. At Arnold & Itkin LLP, our attorneys have the knowledge and experience to take on large pharmaceutical corporations like GlaxoSmithKline and hold them accountable for their actions.

For a free consultation with an experienced attorney, contact a medical injury attorney online or phone Arnold & Itkin LLP toll free at 1-866-222-2606.

Avandia Questions & Answers

(Source: FDA.gov)

What is Avandia used for?

Avandia, in addition to diet and exercise, improves blood sugar control in adults with type 2 (non-insulin-dependent) diabetes. Avandia can be used alone or in combination with a sulfonylurea, metformin, or insulin. Avandia can also be used in addition to a sulfonylurea plus metformin when diet, exercise, and both agents are not enough to control blood sugar.

Who should not take Avandia?

Do not use Avandia for type I diabetes (juvenile diabetes) or diabetic ketoacidosis.
If you have heart failure, fluid retention, or active liver disease your healthcare provider will evaluate you to decide if Avandia is right for you.

General Precautions with Avandia:

Avandia is in the same class of drugs as Rezulin, which has been associated with rare but serious liver injury, including liver failure leading to transplant or death. Because Avandia’s liver safety profile is not fully determined yet, your doctor will do blood tests that evaluate your liver before starting you on Avandia. These blood tests should be repeated every two months for the first year, then regularly after that.
Call your healthcare provider right away if you develop nausea, vomiting, stomach pain, a feeling of tiredness or having no energy, loss of appetite, dark urine, or jaundice (yellow coloring of eyes and skin). These may be symptoms of liver problems.
Patients who experience an unusually rapid increase in weight or retain fluid (edema) or who develop shortness of breath or other symptoms of heart failure while on Avandia should immediately report these symptoms to their healthcare provider.
Call your doctor if you develop visual symptoms, such as decreased vision or blurry vision, while taking Avandia. Some patients have developed macular edema (a swelling in the back of the eye) while taking Avandia. All patients with diabetes should have eye examinations regularly, no matter what medicine(s) they are taking for diabetes..
When taking Avandia with other oral diabetes medicines, there is a risk of your blood sugar becoming dangerously low. Ask your healthcare provider about symptoms of low blood sugar, conditions that make low blood sugar more likely, and what to do if you get it. Make sure to explain to family members.
If you are a woman who has not reached menopause but have not had menstrual periods, you may become pregnant unless you use an effective method of birth control. Avandia, like other drugs in this class, may cause insulin resistant women to start ovulating again.
Women should tell their doctor if they notice any changes in their monthly menstrual cycle.
During periods of stress on the body, such as fever, trauma, infection, or surgery, your medication requirements may change; contact your healthcare provider promptly.

Managing your diabetes should include diet control. Caloric restriction, weight loss as needed, and exercise are essential for the proper treatment of diabetes because they help improve insulin sensitivity and the effectiveness of drug therapy.

What should I tell my doctor or healthcare provider?

Tell your healthcare provider if you are trying to become pregnant, are already pregnant, or are breast-feeding.

Because certain other medication may interact with Avandia, review all medications that you are taking with your healthcare provider, including those that you take without a prescription.

What are some possible side effects of Avandia?

(This list is NOT a complete list of side effects reported with Avandia. Your healthcare provider can discuss with you a more complete list of side effects.)

cough or cold
headache
inflammation of the sinuses
back pain
swelling or fluid retention

Reports of Patients’ Experiences After Avandia Became Available:

There have been reports of inflammation of the liver (hepatitis) and elevated liver enzymes. It has not been determined whether these events are directly related to Avandia. It is recommended that patients taking Avandia have their liver enzymes monitored periodically.

More Information on Avandia Injury

FDA Issues Safety Alert on Avandia

FDA.gov - May 21, 2007