Anti-diabetic medications were developed as a treatment for individuals suffering from diabetes. Diabetes is a serious disease in which the body does not properly use insulin, a natural substance which helps control blood sugar levels. One of the former blockbuster anti-diabetic drugs approved by the FDA in 1999 was Avandia, a thiazolidinedione anti-diabetic designed specifically to treat Type 2 diabetes. Avandia (rosiglitazone) increases the body’s sensitivity to insulin, thereby helping the body control the amount of sugar in the blood. The drug became increasingly popular once it entered the market, and according to national estimates, approximately 600,000 people are currently taking Avandia in the United States alone. Unfortunately, according to new data provided by Avandia studies and reviewed by the FDA, people who take Avandia may have a significantly increased risk of suffering severe, life-threatening side effects, including heart attacks. Furthermore, additional information has indicated that Avandia manufacturer, GlaxoSmithKline, may have been aware of the potential dangers associated with their drug, but chose to conceal this information from consumers and federal drug regulators.
A heart attack occurs when the blood vessels responsible for carrying blood to the heart are blocked, depriving the heart of the oxygen it requires. Without an adequate supply of oxygen, the heart muscle may become permanently damaged and may even begin to die. Most heart attacks are caused by a blood clot which blocks one of the coronary arteries, which bring blood and oxygen to the heart. The most common symptom of a heart attack is chest pain, although the pain may also affect the arms, shoulder, teeth, neck, abdomen, back or jaw. Other symptoms of a heart attack include:
Heart attacks are extremely serious and require immediate medical attention. Arrhythmias, or irregular heart beats, are the leading cause of death in the first few hours after a heart attack. In order to monitor the heart and prevent further complications, heart attack victims are typically hooked up to an ECG machine. Common treatment methods for a heart attack include supplemental oxygen and the placement of an IV into one of your veins in order to quickly deliver fluids and medication. Some types of heart attacks may require emergency procedures like angioplasty or open heart surgery.
The potential for recovery after a heart attack depends largely on the severity and location of the damaged tissue. Approximately one-third of heart attacks result in fatality, and others may cause serious complications, including congestive heart failure, inflammation around the lining of the heart, irregular heart beats, blood clots in the lungs or brain, and damage to the heart valves or the wall separating the two sides of the heart.
According to a 2007 study published in the New England Journal of Medicine, Avandia use was associated with a significantly increased risk of heart attack and an increased risk of death from 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, and presented to the FDA, Graham concluded that Avandia may be responsible for as many as 100,000 heart attacks, strokes, cases of heart failure, and deaths since the drug entered the market in 1999. Graham’s report consisted of a review of more then 220,000 federal health program patients who began taking Actos or Avandia from July 2006 to June 2009 and were monitored for approximately three years. According to the study, patients who took Avandia increased their risk of stroke by 27%, heart failure by 25%, and death by 14%, compared to patients taking Actos.
As startling new information concerning the alleged side effects of Avandia has surfaced, 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 medications. According to a statement released by the FDA in 2008, the agency will no longer approve anti-diabetic drugs simply because they help control blood sugar levels, amending the standard which has been in place for more than eighty years. In the future, the FDA will insist that drug companies conduct clinical trials for more than two years in order to adequately illustrate the drug’s ability to treat diabetes without causing major heart side effects. 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. Moving forward, Avandia use will be restricted to patients already taking the drug, patients whose diabetes cannot be effectively treated with any other medications, and patients who have chosen not to take Actos for medical reasons. In the future, Avandia use may be even further restricted, or the drug may be removed from the market altogether, following the example of countries in Europe, the UK and New Zealand.
Although Avandia may effectively treat Type 2 diabetes, the side effects potentially associated with the drug may significantly outweigh even the best possible benefits of the treatment. Unfortunately, heart attacks are the leading cause of death for men and women worldwide, and taking Avandia may increase this risk. If you or a loved one has suffered from a heart attack, which you believe to be caused by Avandia, contact an Avandia attorney to discuss your legal options. You may be entitled to financial compensation for your injuries, medical expenses, and pain and suffering, which you can collect by filing an Avandia lawsuit against GlaxoSmithKline. Drug companies are responsible for the safety of their medications, even after they enter the market, and should be held accountable for any adverse side effects sustained by consumers of their products. Unfortunately, some pharmaceutical companies intentionally conceal the more serious side effects of their drugs in order to expedite the FDA approval process and ensure their product is well-received by the public. This deceptive practice puts millions of consumers at risk of suffering severe injury and even death, just by taking their prescription medications. Only by hiring an Avandia lawyer to represent their case can victims of alleged Avandia side effects protect their rights and receive the compensation they deserve.