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Practice Areas:

Avandia® (rosiglitazone maleate)

Liver Failure, Heart Attacks

 

NEWS ALERT, September 23, 2010: The FDA announced today that Avandia® will be restricted to Type-2 diabetes patients who have not been able to control their condition with other pharmaceutical products.  CNN reports that the European counterpart of the FDA recommended that Avandia® be taken off the market. For more information, click here for CNN report, here for revised FDA Avandia® page, or see links below
 

Avandia® is the trade name used by GlaxoSmithKline for rosiglitazone maleate, a drug prescribed for the treatment of Type 2 Diabetes. The drug is also marketed as Avandamet® (rosiglitazone maleate and metformin HCI) and Avandaryl® (rosiglitazone maleate and glimepiride). While the drug has been beneficial for some patients, there are significant concerns and evidence that the risk of heart attack and stroke resulting in death is significantly higher than originally marketed to the public.

 

NEWS ALERT, July 13, 2010: A group of doctors have filed a lawsuit against the FDA for failing to alert diabetes patients to safer alternatives to the drug Avandia® and other drugs that may increase the risk of stroke, heart attack and death. Click here for the law.com article or see link below

 

NEWS ALERT, July 12, 2010: The New York Times reports that the manufacturer of Avandia® secretly began a study to see if the drug was safer than competing products. Upon finding that is was not, and that it actually had far more serious risks, the manufacturer hid the data. Click here or see the New York Times link below

 

NEWS ALERT, June 28, 2010: Senator Charles Grassley (R-Iowa) and Representative Rosa DeLauro (D-Conn.) call for removal of Avandia® from the market, due to new research showing increasingly dangerous side effects of heart attacks and strokes leading to death in patients 65 and over. Click here for article from "The Hill"
 
 NEWS ALERT, June 18, 2010: Germany's Federal Joint Committee of Doctors and Health Insurers told health insurers and practitioners to stop paying for the drug Avandia® due to the risks of death from heart attacks and strokes. They also cited increased risk of bone fractures.  Click here for Reuters news article or see link below.
Sheller, P.C. attorneys are investigating cases involving these serious and potentially fatal side effects:
• Death
• Heart attack
• Stroke
• Liver injury/failure
• Angina (severe chest pain)
• Congestive Heart Failure
• And other heart-related conditions and injuries.
 
Potentially dangerous and permanent symptoms and side effects are:
 
• Loss of vision due to macular edema
• Anemia
• Bone fractures 
• Chest pain
• Breathing problems
• Confusion and disorientation
• Excessive, rapid weight gain
• Edema (swelling, particularly of the arms and legs)
• And more, including dangerous side effects of using Avandia® or the generic in combination with other drugs. 

The controversy about Avandia’s®  safety first became public when a 2007 study was published in the New England Journal of Medicine indicating that the drug appears to have a 40% increase, rather than decrease, of the most serious complication of diabetes, heart disease.  The FDA issued the first of several public safety alerts, mandated a “black box” warning and more. The FDA Commissioner had to brief the U.S. House of Representatives Committee on Oversight and Government Reform on steps taken by the FDA to study and release to the public information about the dangerous side effects of Avandia®. The Wall Street Journal discussed the issue as well.
 
 
In 2009, several studies indicated increased concern over the drug's safety, concluding that the risks of Avandia® “far outweigh its benefits and because much safer alternatives exist” for treatment of Type 2 diabetes.
 
 
Avandia® has also been linked to anemia and vision loss from macular edema, a swelling of the retina caused by fluids accumulating in the eye. The consumer watchdog group Public Citizen reports that the American Diabetes Association and the European Association for the Study of Diabetes unanimously avised against using Avandia® (rosiglitazone) because of concerns about the drug's risks. In July of 2009 Public Citizen published research in the medical journal Pharmoepidemiology and Drug Safety  that the risks of Avandia® “far outweigh its benefits and because much safer alternatives exist” for treatment of Type 2 diabetes. On behalf of 80,000 consumers, Public Citizen petitioned the FDA to ban the drug.
 
Type 2 diabetes either doesn’t make enough insulin or ignores insulin present in the body. According to the Centers for Disease Control, 90 to 95% of the 18 to 20 million diagnosed cases of diabetes are Type 2. Treatment for diabetes can be one of three things or a combination: Insulin, oral medication, and diet and exercise.  The CDC estimates that 70% of all diabetic individuals are taking oral medication alone or in conjunction with insulin.  Therefore, the market for oral diabetes drugs is very strong. Prescriptions for the drug decreased to 4.6 million in 2008 from 13.2 prescriptions in 2006, and is still prescribed in either brand name or generic form between 8,500-10,000 times a day.
 
The attorneys at Sheller, P.C. are investigating these cases.

If you or someone you know has experienced and/or been diagnosed with any of these side effects while taking or after completion of Avandia® treatment or the generic equivalent, do not discontinue the drug, consult your healthcare professional immediately and contact us now to learn your rights and protect your health.
 
Related Information:

FDA Avandia® page updated September 23, 2010:  http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm226956.htm

CNN: Avandia® restricted by FDA (and recommended for withdrawal in Europe), September 23, 2010: http://pagingdrgupta.blogs.cnn.com/2010/09/23/avandia-access-restricted-by-fda/

 

Law.com: Doctors group sues FDA over diabetes drug labeling, July 13, 2010  http://www.law.com/jsp/article.jsp?id=1202463478150&Doctors_Group_Sues_FDA_Over_Diabetes_Drug_Labeling

New York Times: Diabetes drug maker hid test data, files indicate, July 12, 2010  http://www.nytimes.com/2010/07/13/health/policy/13avandia.html?scp=5&sq=Avandia&st=cse

The Hill: Grassley & DeLauro criticize FDA's stance on Avandia® following critical JAMA studies, June 28, 2010
 http://thehill.com/blogs/healthwatch/prescription-drug-policy/105999-grassley-delauro-press-for-fda-to-pull-avandia-from-the-market-following-critical-jama-studies
 
Bloomburg Business Week: Glaxo's Avandia® should be pulled, Doctors Say, June 28, 2010
 http://www.businessweek.com/news/2010-06-28/glaxo-s-avandia-should-be-pulled-doctors-say.html
 
Reuters: German drugs gatekeeper rejects GSK's Avandia® Pill, June 18, 2010
http://www.reuters.com/article/idUSLDE65H0IJ20100618
 
FDA "Black Box" warning: http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021071s034lbl.pdf
 
Testimony of the FDA Commissioner to the U.S. House of Representatives on steps taken to alert the public to the side effects of the drug: http://www.fda.gov/NewsEvents/Testimony/ucm153838.htm
 
Wall Street Journal article:  http://online.wsj.com/article/SB119368788686575239.html
 
Public Citizen report: http://www.citizen.org/hot_issues/issue.cfm?ID=2368
 
Public Citizen published research: http://www3.interscience.wiley.com/journal/122515696/abstract?CRETRY=1&SRETRY=0
 
Public Citizen petition: http://www.citizen.org/publications/release.cfm?ID=7614

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Related Media
Avandia® (rosiglitazone maleate)
NEWS ALERTS: In 2009-2010, the manufacturer of the drug Avandia® has come over fire for allegedly withholding vital health safety information. Both the U.S. and European drug regulatory agencies have increased warnings and in Europe recommended the drug be taken off the market.

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