Prescription drugs with unhealthy, dangerous, and potentially deadly side-effects are a persistent cause of debilitating injury to Americans. The Food and Drug Administration (FDA) is the lead governmental agency tasked with overseeing issues of drug safety, and in instances of immediate danger, it is empowered to issue recall orders for products deemed harmful. In February 2010, following years of scientific studies, the FDA was formally petitioned for a ban and recall of the prescription drug Avandia.
Avandia is a commonly prescribed drug that is intended to assist those with Type-2 Diabetes gain control of their blood glucose levels. It was first released by GlaxoSmithKline in 1999, and is known generically as thiazoliodinedione. Initial data regarding side-effects from the use of Avandia noted the potential for the following fatal side-effects:
- Heart attack [interruption of blood supply to the heart]
- Congestive heart failure [insufficient or failed cardiac output]
- Stroke [interruption of blood supply to the brain]
- Pulmonary embolism [blood clotting within the lungs]
Additional side-effects, of an immediately non-fatal though damaging nature, are:
- Bone fractures, particularly in the extremities
- Pulmonary hypertension [excessive blood pressure within the lungs]
Several patient factors were found to contribute to elevated risk, including history of heart attack, heart disease, liver disorders, stroke, congestive heart failure, diabetes-related vision problems, and/or high blood pressure/hypertension. Increased incidence of hypoglycemia (dangerously low blood sugar) was noted in Avandia patients that were also taking birth control pills, diuretics, asthma medications, steroids, anti-convulsant drugs, and/or thyroid medications.
Historic FDA Warnings Regarding Avandia
Reports of these side-effects have provoked numerous lawsuits, as well as action by the FDA to warn consumers of the potential for harm resulting from the use of Avandia. In 2007, the FDA issued a national alert to health professionals and the public at large warning of these side-effects. The FDA also required GlaxoSmithKline to include so-called ‘black box’ warnings on Avandia labels. Black box warnings are the most serious advisories required by the FDA, and are reserved for warnings about the potential for immediately fatal drug side-effects.
Clinical Evidence of Fatal Side-Effects Resulting from the Use of Avandia
In September 2007, the Cleveland Clinic released the long-awaited results of their study of the side-effects of Avandia, which noted the following conclusions regarding Avandia patients:
- 43% increased likelihood of heart attack
- 50% increased likelihood of congestive heart failure
- 64% increased likelihood of sudden cardiac death
Compensation for Patients Who Have Suffered from Avandia Side-Effects and Complications
Avandia is currently under review by the FDA for a potential recall announcement. Despite the fact that a recall has not yet been announced, the evidence for both fatal and non-fatal side-effects resulting from the use of Avandia is abundant.
If you or your loved ones have been injured as a result of taking Avandia, you may be entitled to compensation. Contact New York Injury lawyers at Gersowitz Libo & Korek, P.C. for a free consultation in order to explore your full legal rights. We are experienced litigators in the field of drug injury & liability, and our team of skilled attorneys has the experience, knowledge, and determination to ensure that you receive the full recompense that you are legally entitled to.