Avandia and TZDs: Do the Benefits Outweigh the Risks?
Avandia, known generically as rosiglitazone, belongs to a class of medications called thiazolidinediones (TZDs) and is manufactured by the British-based pharmaceutical company GlaxoSmithKline (GSK). TZDs, a group of drugs that lowers insulin resistance, work by increasing the body’s glucose, or blood sugar, capacity. Doctors and healthcare professionals agree that TZDs have positive results: they stabilize glucose, improve lipids, lower blood pressure, and have anit-inflammatory effects. However, the repercussions of TZDs use greatly outweigh the benefits.
The tainted history of TZDs reveals its dangerous nature beginning with its first use as an anti-diabetic drug in the late 1990s. Approved in 1997 by the U. S. Food and Drug Administration (FDA), Rezulin was the original anti-diabetic in the TZDs class. Yet, because of its link to liver failure, it was quickly pulled from the market less than three years later.
Avandia, approved in 1999, after a questionably quick application process, was first believed to be a miracle drug because of its ability to stabilize blood sugar levels. Yet, it too has also been highly scrutinized since its approval; this time because of its link to heart failure and stroke. In 2007, after reviewing post-marketing adverse events reports, the U. S. Food and Drug Administration (FDA) “determined that an updated label with a boxed warning (the FDA’s strongest form of a warning) on the risks of heart failure was needed for the entire thiazolidinediones class of anitdiabetes drugs.”
Yet, continued studies proved a label update was not enough. In response to further data, the FDA, in September 2010, significantly restricted Avandia’s use to only Type 2 patients who cannot control their blood sugar with other medications. Finally, in May 2011, restrictions on the drug became even tighter: beginning November 18, 2011, as part of a Risk Evaluation and Mitigation Strategy (REMS), in order for patients to receive Avandia, he or she must be enrolled in the Avandia-Rosiglitazone Access Program. To receive Avandia, patients must undergoing extensive education about the drug’s severe side effects and links to heart failure, sign documents acknowledging the risks, and registering with the program.
Heart failure is a condition that results in the heart’s inability to adequately satisfy the body’s requirements. The heart continues to work, but the body’s need for blood and oxygen is not fulfilled. Gradually, the heart’s pump action becomes less and less powerful. Then, blood fails to move efficiently through the circulatory system. Eventually, the blood backs up and causes increased pressure in the blood vessels and forces fluid into body tissue. Congestive heart failure (CHF) occurs when various body parts fill with fluid—the body becomes “congested” with the accumulation of blood and fluid in the veins and lungs.
Edema, fluid retention and swelling in the extremities such as the legs, feet, arms, and hands, has a long- established link to heart failure. An American Heart Associate informational flyer on heart failure warns, “edema that sometimes accompanies the use of a thiazolidinediones can be cause for concern, as it may be a harbinger or sign of congestive heart failure.” Edema results when small blood vessels leak fluid into nearby tissues. Swollen extremities that “dimple” when pressed often signify edema. Contact a doctor immediately if at any point you suspect you have developed edema.
Other Symptoms of Heart Failure:
- Chest Pain or Discomfort
- Heart Palpitations
- Lightheadedness or Dizziness
- Syncope (Fainting or Loss of Consciousness)
- Fatigue, Lethargy, or Daytime Sleepiness
- Shortness of Breath
- Increased Urination
The link between TZDs and Avandia is obvious. According to the FDA, from 1999-2007, an estimated 83,000 heart attacks were caused in patients taking Avandia. A study published in The New England Journal of Medicine revealed that the risk of congestive heart failure while on Avania increases by 64 percent. Why, then, did it take so long to restrict Avandia use? As reported in a New York Times article dated February 23, 2010, a Congressional investigation “concluded that GlaxoSmithKline had threatened scientists who tried to point out Avendia’s risks.” Even though the company’s researchers agreed with Dr. Nissen’s study, GSK failed to inform the public of these findings in order to hide evidence and increase sales. As a result, thousands have suffered from Avandia’s serious and often fatal side effects.
If you are experiencing any signs of heart failure, call your doctor immediately. Any individual or the relative of an individual who has suffered due to Avandia’s side effects is permitted to file a lawsuit. The lawyers can help you determine whether you are qualified to seek compensation. You may be eligible to seek reimbursement for medical expenses, compensation for pain and suffering, and punitive damages (compensation granted for losses suffered). If you need further information about the harmful side effects of Avandia or legal advice concerning personal injury matters, we invite you to contact us or to fill out our form on this website for a free case evaluation.