Diabetes is a serious condition in which the body doesn’t use insulin properly, a natural substance which helps control blood sugar level. In order to treat diabetes, many physicians prescribe anti-diabetic medications like Avandia. The drug belongs to a class of anti-diabetics 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 developed specifically for the treatment of Type 2 diabetes and is currently manufactured by GlaxoSmithKline. Avandia was approved by the FDA in 1999 and quickly became the best-selling anti-diabetic drug on the market. In fact, is it estimated that approximately 600,000 people are currently taking Avandia in the United States alone. Unfortunately, extensive research has raised serious concerns about the safety of Avandia, as studies have shown a possible connection between the drug and life-threatening side effects like heart disease. Although Avandia has been removed from the market in European countries, the UK and New Zealand because of these potential dangers, the drug remains available on the U.S. market with new restrictions instituted by the FDA.
Heart disease, also known as coronary artery disease, is characterized by a narrowing of the small blood vessels that are responsible for supplying the heart with blood and oxygen. As the coronary arteries become narrower, the flow of blood to the heart can slow down or stop altogether, depriving the heart of the blood and oxygen it needs to function properly. Common symptoms of heart disease include shortness of breath, chest pain, heart attack, and other symptoms typically occurring when the person is active.
Proper treatment for heart disease depends on the symptoms exhibited by the person, as well as the severity of the disease. Common treatment methods include receiving medications to lower blood pressure, prevent blood clots, and relax arteries; lifestyle changes including reducing salt intake, getting regular exercise, and keeping blood sugar under control; and sometimes undergoing procedures like angioplasty, heart surgery or coronary artery bypass surgery. In some cases, especially when treatment is prompt, victims of heart disease can make a full recovery. Unfortunately, some people may suffer from heart attack, unstable angina, heart failure and sudden death.
In 2007, the New England Journal of Medicine published a study which indicated that patients taking Avandia had a significantly increased risk of heart attack and an increased risk of death due to cardiovascular causes, compared to patients who took other anti-diabetic drugs and patients who took no anti-diabetic drugs. In a report compiled by FDA scientist Dr. David Graham, more than 220,000 federal health program patients who took Actos or Avandia between July 2006 and June 2009 were reviewed. According to the 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 notified the FDA that as many as 100,000 cases of stroke, heart failure, heart attack and death may have been associated with Avandia use since the drug was first introduced in 1999.
After reviewing new Avandia side effect data, the FDA has promised to take a more restrictive approach in the treatment of diabetes and a more cautious stance in the approval of anti-diabetic drugs in the future. The FDA released a statement in 2008 notifying consumers and drug companies that the agency will no longer approve anti-diabetic medications simply because they help control blood sugar levels, a standard that has been in place for more than eighty years. Instead, the FDA will require pharmaceutical companies to conduct clinical trials for more than two years in order to illustrate the drug’s ability to improve or lengthen the life of diabetics without causing irreparable damage to the heart. In addition, the FDA has required GlaxoSmithKline to change Avandia prescribing information to include new safety information and updated restrictions on the use of the drug. According to these restrictions, Avandia will only be used by patients already taking the medication, patients whose condition cannot be successfully treated with alternative medications, and patients who have chosen not to take Actos for medical reasons.
Heart disease is the leading cause of death for men and women in the United States, and taking Avandia may significantly increase an individual’s risk of developing heart disease. If you or a loved one has suffered from heart disease and you believe Avandia to be the cause, contact an Avandia attorney immediately. You may have grounds to file an Avandia lawsuit against GlaxoSmithKline in order to seek financial compensation for your injuries, medical expenses and pain and suffering. Defective drug lawsuits also bring public attention to the importance of safe medications and the need for more stringent regulations on the dangerous drugs currently on the market.
Victims of serious injuries caused by the proper use of a dangerous drug are not at fault. Pharmaceutical companies like GlaxoSmithKline are expected to manufacture and market safe medications and they should be held responsible for any adverse side effects sustained by consumers of their products. Unfortunately, some drug companies intentionally withhold dangerous drug information in order to prevent negative consequences, such as a drug recall. In fact, there is significant speculation that GlaxoSmithKline may have actually been aware of the harmful nature of Avandia, but chose to conceal this information from consumers and federal drug regulators. These deceptive practices expose millions of consumers to serious, unnecessary harm and even death without their knowledge. With the help of an experienced Avandia lawyer, victims of alleged Avandia side effects can collect the compensation they deserve, and feel confident that their case is being effectively and professionally represented.