Since 1999, the prescription drug Avandia (rosiglitazone) is a medication which has been prescribed to hundreds of thousands of diabetics to control their blood glucose (sugar) levels. However, on February 03, 2011, the United States Food and Drug Administration issued the following Safety Announcement about Avandia: “The U.S. Food and Drug Administration (FDA) is notifying the public that information on the cardiovascular risks (including heart attack) of the diabetes drug rosiglitazone has been added to the physician labeling and patient Medication Guide. This information was first announced by FDA on September 23, 20101 as part of new restrictions for prescribing and use of this drug.” As a result of the risks to people with heart disease who take Avandia, GlaxoSmithKline, the manufacturer of Avandia, issued a black box warning with the following heading: “WARNING: CONGESTIVE HEART FAILURE AND MYOCARDIAL INFARCTION.” This warning then states, “Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some patients. After initiation of AVANDIA, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of AVANDIA must be considered. AVANDIA is not recommended in patients with symptomatic heart failure. Initiation of AVANDIA in patients with established NYHA Class III or IV heart failure is contraindicated.
However, doing a complete turn around on November 25, 2013, the FDA issued the following Safety Communication: “The U.S. Food and Drug Administration (FDA) has determined that recent data for rosiglitazone-containing drugs, such as Avandia, Avandamet, Avandaryl, and generics, do not show an increased risk of heart attack compared to the standard type 2 diabetes medicines metformin and sulfonylurea. As a result, we are requiring removal of the prescribing and dispensing restrictions for rosiglitazone medicines that were put in place in 2010. This decision is based on our review of data from a large, long-term clinical trial and is supported by a comprehensive, outside, expert re-evaluation of the data conducted by the Duke Clinical Research Institute (DCRI).” This recent switch in position will, no doubt, have a substantial detrimental effect on current cases against the manufacturers of these medications.
None-the-less, if your physician has prescribed Avandia for you, you should immediately discuss whether there are safer alternative drugs for you. After weighing the risks and benefits, you and your physician can determine what drug is best for you. If you live in California, have taken Avandia, and have suffered a heart attack, stroke, or other cardiovascular disease after using the diabetes medication Avandia, you should know that attorney and physician Paul J. Molinaro is available to answer your legal questions and help you determine whether you are entitled to compensation from the manufacturer of this drug. You can reach Paul J. Molinaro, M.D. J.D. toll free at (888)MDJDLAW. The initial consultation is also free, and if Paul determines that you have a case, and you decide to hire Paul, he will represent you on a contingent basis.