Avandia, or rosiglitazone by its generic name, is a dangerous drug used to treat Type 2 diabetes. In 2007, a scientific analysis emerged asserting that Avandia significantly increases one’s risk of heart attack or death due to heart disease. The analysis pooled the results of dozens of short-term clinical studies to reveal that Avandia increases heart attack risk by 43 percent and risk of death from heart disease by 64 percent. Another study published by the American Medical Association in 2010 showed that Avandia users are 1.27 times more likely to suffer strokes, 1.25 times more likely to experience heart failure, and 1.14 times more at risk of death than those who take Actos, a Type 2 diabetes drug in the same class as Avandia. Following these alarming studies, news reports came out in 2010 that a former U.S. Food and Drug Administration (FDA) official said the maker of Avandia, GlaxoSmithKline, had withheld from regulators information that indicated the drug posed an increased risk for serious heart problems.
In response to studies showing Avandia to be a defective drug and public concern over the dangers of Avandia, the FDA reconsidered the drug’s safety. Following a September 2010 decision in which a drug recall was not issued, the agency notified healthcare professionals and patients in early 2011 that the physician labeling and patient medication guide had been revised to include information about the cardiovascular risks (including heart attack) associated with Avandia. Furthermore, the FDA has significantly limited the use of the drug, requiring that GlaxoSmithKline develop a restricted access program under a risk evaluation and mitigation strategy (REMS). This means Avandia will be available to new patients only if they are unable to take Actos, the other drug in the same class as Avandia, and are unable to control glucose with other types of medication. Also, current users of Avandia who are benefitting from the drug will be allowed to continue using it if they so choose. As part of the REMS program, doctors will have to attest to and document their patients’ eligibility to receive Avandia, and patients will have to review statements concerning the cardiovascular risks of Avandia and acknowledge they understand the dangers.
Although Avandia is still on the market in the United States, its restricted availability attests to the cardiovascular dangers users face when taking the drug. In fact, Avandia became a recalled drug in Europe last September. Avandia users who have been harmed by the drug can work with an experienced drug lawyer to fight for the compensation to which they may be entitled under the law.
The dangers of Avandia were addressed again in March 2011 when researchers from the United States and Europe reported in the British Medical Journal that Avandia could lead to 170 excess heart attacks, 649 excess cases of heart failure and 431 excess deaths for every 100,000 people given Avandia instead of Athos. In addition to an increased risk of heart attack or heart failure, Avandia has also been linked to liver failure, though instances of liver failure are rare, and it can cause side effects including headache, cold symptoms, sore throat, back pain, loss of appetite, nausea, vomiting, stomach pain, dark urine, yellowing of the skin or eyes, blurred or loss of vision, difficulty seeing colors or in the dark, pale skin, dizziness, swelling of the eyes, face, lips, tongue or throat, hoarseness, difficulty swallowing or breathing, hives, itching, fever, or blisters.
If you or a loved has been harmed by Avandia, contact our law firm today to discuss your case with a knowledgeable and experienced drug attorney.