Is Avandia a Dangerous Diabetes Drug?

In 2007, the Food and Drug Administration (FDA) ordered GlaxoSmithKline, a pharmaceutical giant that produces and markets many prescription and non-prescription drugs in the United States, to place “black box” warnings on packaging and medical information that comes with the potentially dangerous diabetes drug Avandia. The black box alert is the most severe warning that can be distributed on medication that is legally prescribed by health care professionals. The warning signifies that there is a proven link between the medication and serious adverse reactions, and is reserved for those therapies that could cause extremely painful health problems, or even death.

Avandia was released in 1999, along with two other drugs based on an anti-diabetic compound called Rosiglitazone maleate . The brand name version, which improves insulin resistance levels in victims of type II diabetes, contains only these drugs. Another version of the drug is called Avandamet, which is combined with America’s most popular anti-diabetic drug, known as metformin, which has a few mild contraindications, including gastrointestinal upset and diarrhea. In rare cases, patients with renal failure and poor liver function develop lactic acidosis. The third therapy released was called Avandaryl, which consists of Rosiglitazone mixed with glimepiride, which carries slight risks of similar nature.

In 2007, two studies were released that positively linked Avandia to several life-threatening ailments. One of the studies focused on bone density issues, especially in post-menopausal women. In a significantly high number of these cases, patients receiving the medication developed fractures and breaks in the extremities, including the hands, arms, legs, and feet. However, the bone cracks and bruises are relatively mild compared to the adverse reactions reported in a later study.

This study reported a direct causal link to abnormal fluid buildup, jaundice, and heart failure, which led to the establishment of the FDA requirement for the stringent warning. While jaundice can take time to develop, there are some very clear telltale signs of negative reactions and contraindications, including yellow skin, stomach pain, nausea, and yellowing of the skin and eyes. If you experience any of these issues, contact your healthcare provider immediately for a test of liver function.

Even more troubling than liver failure, however, is the risk of heart failure and pulmonary edema. Pulmonary edema exists when abnormal fluid buildup occurs in the lungs. This can be caused by your diabetes medication. Left untreated, it will eventually lead to death. Heart disease can also be caused by the medication, and may result in complete heart failure. Some early warning signs of this condition include:

Unexplained fatigue
Dizziness
Chest pain and discomfort
Shortness of breath

If you have taken any of the drugs above, and have experienced any of the symptoms described, contact a doctor immediately. Make sure that you receive proper documentation of any and all medical complications. If your doctor or physician confirms that you are experiencing problems caused by your diabetic therapy, contact one of our attorneys now, to determine if you are eligible to take part in a lawsuit to gain recompense.