Avandia, manufactured by GlaxoSmithKline, is an anti-diabetic medication which entered the U.S. market in 1999 and has since become the best-selling drug of its kind. Diabetes is a serious condition in which the body doesn’t use insulin properly, and is therefore unable to control blood sugar levels. Avandia belongs to a specific class of anti-diabetic drugs called thiazolidinediones, which work by increasing the body’s sensitivity to insulin, thereby helping the body control the amount of sugar in the blood. Avandia (rosiglitazone) was specifically designed to treat Type 2 diabetes, and is not used in the treatment of either Type 1 diabetes, in which the body doesn’t produce any insulin, or diabetic ketoacidosis, a condition occurring when high blood sugar is not treated properly. Although Avandia became popular quickly after its introduction to the market, recent research has identified Avandia use as a possible risk factor for the development of serious, life-threatening side effects, including heart failure. Despite these dangers, Avandia remains on the market today, although the FDA has established severe restrictions for the use of the anti-diabetic drug.
Heart failure is a serious condition in which the heart can no longer pump an adequate amount of blood to the rest of the body. In most cases, heart failure is a long-term condition, although it can sometimes occur suddenly and without warning. Heart failure most often affects both sides of the heart, although strictly right-sided or left-sided heart failure can occur in some instances. Systolic heart failure occurs when the heart muscle cannot pump the blood out of the heart well enough, while diastolic heart failure occurs when the heart muscles are stiff and cannot fill up with blood easily. In either condition, the heart is unable to pump a sufficient supply of blood to the rest of the body, depriving the body’s organs and tissues of the oxygen they need to survive.
Heart problems that may lead to heart failure include heart attack, heart valve disease, congenital heart disease, and some types of abnormal heart rhythms. Because heart failure is typically a chronic condition, the accompanying symptoms may occur slowly. In the beginning, symptoms may only arise when the person is active or exercising; over time, the person may begin to exhibit symptoms even while resting. Common symptoms of heart failure include:
Heart failure is a common and extremely dangerous condition which can lead to permanent disability and even death. Although some forms of heart failure can be controlled with treatment, medication and lifestyle changes, others can lead to potentially fatal complications such as arrhythmias, pulmonary edema and total heart failure.
In an attempt to reveal the potential dangers associated with Avandia, Dr. David Graham, an FDA scientist, reviewed more than 220,000 federal health program patients who took Actos or Avandia between July 2006 and June 2009 and were followed for an average of three years. According to Graham’s report, patients who took Avandia had a 27% increased risk of stroke, a 25% increased risk of heart failure, and a 14% increased risk of death, compared to patients taking Actos, a similar anti-diabetic drug. Graham also concluded that as many as 100,000 cases of heart failure, heart attack, stroke, and death may have occurred as a result of taking Avandia since the drug was introduced in 1999. In 2007, the New England Journal of Medicine published a study in which researchers found a significantly increased risk of heart attack and an increased risk of death due to cardiovascular causes among patients who took Avandia, compared to patients who received other anti-diabetic treatment and patients who received no anti-diabetic treatment.
In light of this new Avandia information, the FDA has instituted a more cautious and restrictive approach in the treatment of diabetes, as well as in the approval of anti-diabetic medications. In 2008, the FDA issued a statement declaring that the agency will no longer approve anti-diabetic drugs simply because they help control blood sugar levels, which is the standard that has been in place for more than eighty years. Moving forward, the FDA will require pharmaceutical companies to conduct clinical trials for more than two years in order to demonstrate the drug’s ability to successfully treat diabetes without causing irreparable damage to the heart. The FDA has also required GlaxoSmithKline to change Avandia prescribing information to include new safety information and updated restrictions on the use of the drug. These restrictions dictate that Avandia will only be used by patients who are already using the medication, patients whose diabetes cannot be successfully treated with any other drug, and patients who have medical reasons for not taking Actos.
In order for a new drug to be approved by the FDA, the possible benefits of the drug must outweigh the potential risks associated with the treatment. This regulation is in place in order to protect consumers from unnecessary harm inflicted by potentially dangerous drugs. Unfortunately, some drug manufacturing companies employ deceptive practices in order to side-step this safety measure, subsequently putting millions of consumers at risk of suffering serious injury and even death. In some cases, pharmaceutical companies may conceal the harmful nature of their product in order to ensure their drug is approved by the FDA and well-received by the public. In fact, recent information has indicated that GlaxoSmithKline may have been aware of the potential dangers of Avandia use, but went to great lengths to conceal this information from consumers and federal drug regulators. If you or a loved one has suffered from heart failure and you believe Avandia to be the cause, contact an Avandia attorney to discuss the benefits of filing an Avandia lawsuit against GlaxoSmithKline.
The goal of Avandia lawsuits and potential Avandia class action lawsuits is to seek financial compensation for your injuries, the medical expenses resulting from injury treatment, and the pain and suffering incurred by you and your family. You are not at fault for injuries caused during the proper use of a dangerous drug. Drug companies are responsible for the safety and effectiveness of their medications, and should be held accountable for any injuries sustained by consumers of their products. The only way for victims of alleged Avandia side effects to protect their rights is to hire a qualified Avandia lawyer to represent their case.