At Sullivan &; Brill, LLP, our New York City defective and dangerous drug lawyers are currently pursuing cases in which consumers have been harmed by GlaxoSmithKline's diabetes medication, Avandia. The U.S. Food and Drug Administration (FDA) recently restricted the use of Avandia, citing links to heart attacks and strokes, and finding that the drug's adverse reactions outweigh its benefits to patients. Nearly 50,000 patients have reportedly suffered some adverse cardiac reaction, even death, while taking Avandia.
Diabetic patients will only be allowed to receive the risky medication if their doctors indicate that every other diabetes medication has been tried and that the patient has been made aware of the cardiac risks associated with Avandia. Patients taking the drug – there are some 600,000 in the U.S. alone – who refuse to switch medications must sign statements acknowledging that they are aware of the drug's cardiac risks.
European regulators suspended Avandia's sales pending release of significant information pointing to Avandia's benefits exceeding its current risks. This is not expected anytime soon. Consumer groups feel the FDA should have followed Europe, removing Avandia from the market. Sadly, the drug remains available, continuing to place patients at risk for very significant adverse reactions.
Meanwhile, a Senate probe revealed that GlaxoSmithKline hid Avandia's increased cardiac risks from regulatory authorities for years. This led to a $2.3 billion liability charge related to legal cases involving, among other medications, Avandia.
Avandia, approved in 1999, is in a class of drugs known as thiazolidinediones, or TZDs, and is generally prescribed, along with diet and exercise, to improve glucose levels and glucose control in patients diagnosed with Type 2 Diabetes Mellitus. The medication is meant to make diabetics more sensitive to their own insulin, which ultimately regulates glucose levels.
Avandia's label has included the FDA's strongest safety warning, its black box label, since 2007, outlining links to myocardial ischemia. The strict warning was added following a meta-analysis conducted by the renowned Cleveland Clinic in which it analyzed 42 clinical trials pointing to a significant 43% increase of patients experiencing a heart attack when taking Avandia. Evidence continues to mount connecting Avandia to heart attack, stroke, and death.
World-known Cleveland Clinic Cardiologist Dr. Steven Nissen's studies made groundbreaking links between cardiac risks and Avandia, calling the debacle "one of the worst drug safety tragedies of our time." Sadly, it is believed that over 47,000 patients taking Avandia suffered from heart attacks or strokes, with some dying, based on the period studied, from 1999 to 2009. According to Dr. Nissen, it is "essential to fully investigate what went wrong with the regulatory process to prevent this type of tragedy from endangering patients in the future." Dr. Nissen was referring to the drug approval process previously in place for diabetic medications, which simply involved proof that the medication helped control blood sugar levels. Now, trials must span two years and must show that the medication being tested improves the quality or length of diabetics' lives and causes no cardiac harm. It could be some time before these mandates are in place, leaving other diabetes patients open to the potential of suffering adverse reactions to diabetes medications.
Our defective drug attorneys at Sullivan & Brill, LLP can assist you, if you or someone you care about has been injured or lost his / her life due to adverse reactions associated with treatment with the diabetes medication, Avandia.
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