Avandia is not the drug the Food and Drug Administration (FDA) originally thought it was. Studies are revealing worldwide GlaxoSmithKline's (GSK) Avandia is a significant risk to patients.
1. What is Avandia, and why is it prescribed?
Avandia is the brand name of the drug rosiglitazone. It is used with diet and exercise to reduce blood sugar in type 2 diabetes patients, those who are non-insulin dependent, by sensitizing the body to better use its own insulin.
Avandia was approved by the FDA in 1999. By 2006, 13.2 million people were taking Avandia, and at least four million were still taking the drug in 2008. Avandia's patent expires in 2009.
2. What has changed since 1999?
In 2001, Dr. John B. Buse wrote a letter to the FDA regarding the increased risk of heart attack in Avandia patients. Dr. Buse went on to study Avandia's effects and review information GSK presented to the FDA prior to its approval.
The FDA ordered GSK to provide package and label warnings about the risks. GSK was slow to respond and was ordered to provide the warnings again.
The FDA sent undercover investigators to a pharmaceutical conference where GSK had not sufficiently posted warnings on materials promoting Avandia. In May 2001, the FDA ordered GSK to write letters to doctors prescribing Avandia warning them of the risks.
Long term studies and reevaluation of initial studies of Avandia, released in 2007, show patients using the drug have a 30-40 per cent higher risk of heart attack (myocardial infarction) and heart events, such as fluid retention, swelling and congestive heart failure.
By 2008, doctors and patients had reported to the FDA 14 cases of liver failure. Twelve resulted in death.
3. Why did the FDA issue an alert in 2007?
Based on the findings of the studies reported in 2007, the FDA issued an alert for all physicians to reassess patients taking Avandia in light of the increased risk of heart-related events.
The FDA chose not to recall the drug when it issued the alert because there is inherent risk for patients who change medications for diabetes even with no other specific risk factors.
GSK was ordered to continue providing labels bearing the warning of the increased heart risk while the FDA investigates additional study data to determine if the heart-related events and deaths of Avandia patients were due to taking the drug.
4. Are there other risks?
Public Citizen, the Health Research Group (HRG) filed a petition with the FDA to recall Avandia based on twelve fatal cases of liver failure, citing FDA Event Adverse Reporting System. The petition claims Avandia pre-marketing literature veiled the truth about liver toxicity.
Macular edema (swelling of the retina which causes sight loss), bone fractures, especially in women, and anemia are more risks associated with Avandia use.
Other risks include, hypoglycemia and hyperglycemia, upper respiratory distress or shortness of breath, headache, nausea, jaundice, back pain, fatigue, nasopharyngitis, loss of appetite and change in menstrual cycle.
5. I have taken Avandia. What should I do?
If you have developed any of the side effects associated with Avandia, you should immediately see your physician. Some symptoms, like jaundice and shortness of breath, can actually be symptoms of liver or heart failure, which can be life-threatening.
If you believe your symptoms, bone fracture and/or heart or liver problems developed because you took Avandia, contact an attorney.
6. Is there a time limit?
Each state has a statute of limitations, a time limit on when you may file a law suit. After the statute runs out, you may not be able to recover loss wages, medical expenses and punitive damages from the drug company.
After speaking with your doctor, contact an attorney. An attorney can evaluate your case. If you have a case, an attorney can file a lawsuit for you against GSK.
The Court will decide if your case will be consolidated with other Avandia cases into a class action lawsuit.