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On February 22, 2010, the Federal Drug Administration issued a FDA Drug Safety Communication concerning the ongoing review of Avandia (rosiglitazone) and cardiovascular safety.1  Avandia is the brand name of an oral drug called rosiglitazone.2 Avandia is manufactured and sold by the drug company GlaxoSmithKline.3  Avandia is anti-diabetic drug in the thiazolidinedione class of drugs.  The drug is used to treat Type 2 diabetes.4

Thiazolidinediones, in general, and rosiglitazone, in particular, act as “insulin sensitizers.”  These drugs help the body’s cells become more sensitive to insulin, and thereby reduce the glucose in the blood stream.5

Understanding Diabetes

Diabetes mellitus (diabetes) is a disorder thatoccurs when the body does not produce enough insulin, or because body’s cells do not properly respond to the insulin that is produced, thereby resulting in a too high blood sugar (glucose) level.  The blood sugar level With this condition, the glucose accumulates in the blood (hyperglycemia – and may lead to various serious medical complications.6

Type 2 Diabetes

In Type 2 diabetes, the pancreas continues to produce insulin.  The body, however, develops resistance to the effects of insulin.  This condition is known as insulin resistance.7

Avandia Safety Concerns

The FDA issued a safety communication concerning the possible association between rosiglitazone and an increased cardiovascular risk or risk of heart attack.8

Some studies have shown that Rosiglitazone may be linked to fluid retention within the body.  Excess fluid retention may lead to or worsen congestive heart failure because the heart is unable to pump enough blood to the other parts of the body.9

Avandia carries a black box warning that includes the following: “Avandia can cause or worsen heart failure.”  The warning also indicates that “Avandia may increase your risk of other heart problems that occur when there is reduced blood flow to the heart, such as chest pain (angina) or heart attack (myocardial infarction). This risk appeared higher in patients taking medicines called nitrates or insulin.”10

Thiazolidinedione (TZD) use may also be associated with an increased risk of fractures, particularly in women at the age of 65 and above.11

FDA Recommendations

FDA recommendations for patients currently using Avandia (rosiglitazone) include:

  • Not stop taking their medication without talking with their healthcare professional.
  • Report any side effects with rosiglitazone to FDA’s MedWatch program.12

What to do?

If you or a loved one has suffered heart failure or a heart attack while taking Avandia (rosiglitazone), or has suffered a fracture of a bone or a broken bone while taking Avandia (rosiglitazone), you may be entitled to compensation.  You need to speak to a competent personal injury lawyer to evaluate your claim and protect your interests.


AVANDIA® is the registered trade mark of GlaxoSmithKline.

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