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Avandia Linked to Heart Attacks

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Avandia (rosiglitazone maleate) is a GlaxoSmithKline (GSK) drug developed to treat type 2 diabetes mellitus. First approved by the FDA in 1999, the agency reported eight years later a significant increase in the risk of heart attack in those patients to whom Avandia had been prescribed. And many deaths have been linked to Avandia. More recently, two independent studies showed that bone fractures, particularly in female patients, have been associated with this popular diabetes drug, while a third study has found a link between Avandia and liver failure.

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Avandia Associated with Bone Fractures, Heart Attack, and Death

cipro tendon ruptureAvandia works by reducing insulin resistance and helping the body use the insulin it produces. Approximately 21 million Americans suffer from diabetes, a disease responsible for nearly 300,000 deaths every year. In 2006 almost four million people in the US took Avandia. This diabetes medication was designed to replace Rezulin, a similar drug that was pulled from the market in 2000 after studies revealed it causes severe liver failure. At that time, the FDA conducted studies to test the effects of Avandia and concluded it did not carry the same risks associated with Rezulin.

Now, ongoing evidence suggests that this popular diabetes drug can do a great deal of harm. Safety concerns and side effects that have been associated with Avandia include the following:
  • hypersensitivity
  • cardiac failure
  • hepatic impairment
  • macular oedema
  • bone fracture
In addition to these serious side effects, several other risk factors associated with consuming Avandia include: weight gain, cold, cough, headache, inflammation of sinuses, back pain, swelling, fluid retention and cardiac arrest.

Heart Attack and Death

In May 2007 the FDA announced that information obtained from clinical trials demonstrated that Avandia has the potential to increase the possibility of heart attack by 43 percent and may increase fatalities from general heart disease by 64 percent. Reports have found an increase of heart problems and congestive heart failure in particular occurring as a result of using Avandia.

While Avandia has had much of the media attention recently, Actos--another type 2 diabetes medication--had an increased warning placed on its label by the FDA. The new label indicated the link between Actos and congestive heart failure. Patients who are taking Actos and are concerned about Actos side effects can find more Actos news and Actos lawsuit information here. Additionally, visit our Actos FAQ page for frequently asked questions about Actos.

Bone Fractures

Recent studies have shown that the risk of bone fractures in patients taking Avandia may be almost twice that of those not prescribed the drug. For those who have been taking Avandia for more than two years, the risk of bone fracture is nearly tripled.

In April 2008 the Archives of Internal Medicine determined that patients who had been prescribed Avandia for at least twelve months were almost twice as likely to suffer a bone fracture as those who did not take the drug. More disturbingly, among patients who had treated their diabetes with Avandia for at least two years, bone-fracturing levels had almost tripled.

In another report, The Canadian Medical Association Journal determined that female patients undergoing long-term treatment could double their risk of bone fracture. The study reviewed 10 previous clinical trials, and for every 20 women in their 70s with type 2 diabetes who took the drugs for at least one year, one has a chance of suffering a fracture. In women in their mid-50s, the figure equals one fracture in every 55 women. That's more than double the normal risk for those age groups.

Liver Failure

A study recently published in the journal Pharmacoepidemiology and Drug Safety (July 22, 2009) has reportedly found a link between the use of Avandia and a risk of liver failure. The study, conducted by researchers from the public advocacy group Public Citizen, found that 11 deaths due to liver failure were reported to the FDA in patients who used Avandia. Those deaths occurred between 1997 and 2006. Public Citizen notes that because of a low incidence of adverse event reporting to the FDA, the actual incidence of liver failure in Avandia patients is more likely around 1 in 44,000 patients.

Avandia History

On June 28, 2001 the FDA requested that GSK discontinue distribution of misleading informational materials that minimized the alleged risks of Avandia.

In April 2002, the FDA sent a letter to healthcare providers telling them of changes in the Avandia warning label that now would include the possibility of excess fluid retention and congestive heart failure.

In December 2002, the FDA again asked GSK to revise their warning label to include reports of unusual, rapid increases in weight.

In 2003, a study published in the September 9 issue of the Mayo Clinic Proceedings reported that congestive heart failure can occur in Avandia patients. Already known to cause fluid accumulation, Avandia is being discouraged from use amongst anyone with a history of congestive heart failure or chronic renal insufficiency.

A report in 2008 stated that a government-run diabetes trial involving 10,000 patients was halted 18 months early after a safety analysis revealed an increased risk of death in patients whose blood sugar levels dipped too low.

Avandia Lawsuits

The Wall Street Journal reported in June 2007 that a class-action shareholder lawsuit was filed against GlaxoSmithKline, arguing that the company failed to disclose the heart attack risk that may be associated with Avandia. One month previously, the New England Journal of Medicine published an analysis suggesting that Avandia increases the risk of heart attack. And Glaxo itself had already compiled a similar analysis, which also showed a potential danger. However, the findings weren't reflected on the US label, which is supposed to give a comprehensive review of the drug's risks.

Meanwhile, hundreds of drug safety cases are being filed against Avandia as a result of life-threatening side effects.

In May 2011, South Carolina filed a lawsuit against GlaxoSmithKline, alleging the company misled consumers about potential Avandia side effects. According to the lawsuit, GlaxoSmithKline was negligent in claiming that Avandia did not increase the risk of heart problems. The prosecutor alleges that GlaxoSmithKline knew or should have known that Avandia would not reduce the risk of cardiovascular events in diabetics and that its marketing was therefore misleading. GlaxoSmithKline said it stands behind the medication and Avandia marketing.

Although Avandia has repeatedly been in the spotlight for the controversy surrounding its use, it remains a blockbuster drug for manufacturer GlaxoSmithKline and it remains on the market. Researchers have determined that Avandia needs stronger warnings about potential side effects.

Avandia Legal Help

If you or a family member have used Avandia and have suffered a heart attack or liver damage after taking Avandia, please click the link below to send your complaint to a lawyer who will review your claim at no cost or obligation.

Last updated on Feb-8-14

AVANDIA LEGAL ARTICLES AND INTERVIEWS

FDA Eases Warnings For Avandia
FDA Eases Warnings For Avandia Washington, DC: Earlier this week, the US Food and Drug Administration (FDA) announced it is requiring the removal of certain restrictions on prescribing and use of the diabetes drug Avandia (rosiglitazone). The move is designed to reflect new information regarding the cardiovascular risk of the medicine. The FDA states that their actions are consistent with the recommendations of expert advisory committees [READ MORE]

GSK to Face Avandia Racketeering Class Action Lawsuits
GSK to Face Avandia Racketeering Class Action Lawsuits New York, NY: GlaxoSmithKline (GSK) LLC is facing three federal racketeering class actions, alleging the pharmaceutical company concealed the risk of adverse cardiovascular effect associated with its diabetes drug Avandia, and that it duped health benefit payors into covering the expensive prescriptions. In her ruling, US District Judge Cynthia M. Rufe refused to dismiss claims from three union benefit funds under the Racketeer Influenced and Corrupt Organizations (RICO) Act.[READ MORE]

Testimony against Takeda in Actos Lawsuit Alleges Profits Put before Patients
Testimony against Takeda in Actos Lawsuit Alleges Profits Put before Patients New York, NY: A recent Actos bladder cancer lawsuit alleged that officials at Takeda Pharmaceutical Co., put profits ahead of patient safety when it came to Actos side effects. Testimony at the lawsuit, which was heard in March 2013, alleged the company was against including a bladder cancer warning on the Actos label. The Actos lawsuit resulted in a $6.5 million award to the victim, which was later overturned by the judge [READ MORE]




READER COMMENTS

Posted by
North Carolina
on
I have had problems with my heart after taking Avandia.

Posted by
Tennessee
on
Two heart attacks and a stroke.

Posted by
Arizona
on
After being prescribed Avandia by the VA, I was taken off of it because I had developed cogestive heart failure (CHF). My attending doctor believes it was due to the drug Avandia. This happened several years ago and I continue to suffer more and more because of the CHF. This puts a strain on myself and my family.

Posted by
North Carolina
on
My special needs son and I both were prescribed Avandia for many years. Now we are both on heart medication. I would like to inquire as to any assistance I can get especially considering my son. With him being special needs, he will need care once I'm gone. I am in my 60's and I want to make sure he has care if I were to go from heart conditions related to the Avandia. I would appreciate speaking with someone regarding this.

Posted by
North Carolina
on
Suffered a heart attack behind the bad drug Avandia and had to have heart surgery in 2009.

Posted by
Michigan
on
I have been to a cardiologist and I was diagnosed with ischemia in the lower left part of my heart I have severe pain in my left chest and left arm when I try to do my daily activities. I am no longer able to work. I was on avandia for more than eight years. Please help me.

Posted by
Texas
on
My mother had diabetes and she was prescribed Avandia back in 2006. She was not a big drinker and she ate well. She had significant weight gain, jaundice, liver and kidney failure. We would like help with the class action.

Posted by
California
on
daily chest pain, chronic shortness of breath, must sleep elevated, developed hypertension, fatigue, weakness, sheer exhaustion after simple tasks such as walking upstairs in our home, at risk for stroke or heart attack.

Posted by
Indiana
on
Two heart attacks, congestive heart failure, stints, pacemaker-defibrulator, half my heart left and my life ruined.

Posted by
Arkansas
on
Our family has been devastated by the death of my mother. Her death has left her husband alone in his retirement years, as well as, leaving her children, grandchildren and great grandchildren without a mother, grandmother and great grandmother. Her death was unexpected and we have been left with a growing sense of loss, pain, and mental suffering. All of this on top of our everyday responsibilities and obligations. We would like to pursue a wrongful death claim because she was taking Avandia regularly when she died.


Posted by
Arizona
on
Had to have angioplasty and another surgery to insert (2) stents in my Right Carotid Artery.

Posted by
Wisconsin
on
I ingested 8mg Avandia per day beginning 08/09/2005 until 06/01/2007 when I saw a law firm's TV commercial about the risks of this drug. During the period I ingested Avandia, my LDL spiked from 50 to 186. Per Ct scan on 03/11/2008, I developed Fatty Liver, Atherosclerosis w/vascular calcifications of the aorta. Also, osteoporisis appeared after previous spine bone health showed 15 years less than my chronological age and hips "equivalent to a 20 year old". After Avandia, LDL returned to 50. I have permanently lost good health & well being.

Posted by
California
on
For several years now, I have complained of shortness of breath. My doctor had a heart stress test done in Sept/07. The results were negative. For the last several months I have experienced swelling on my lower legs ankles and feet. On June 26, 2008 I suffered a massive heart attack. I came very, very close to death according to my cardiologist. I expect to suffer from permanent heart damage for the rest of my life.

Posted by
Ontario
on
Avandia side effects caused kidney damage, advanced swelling in legs, arms, even face and body, pneumonia, "snow" blindness, severe anemia and increased dependence on pace-maker. I was only 57 when this happened. Have now been off Avandia over a year, but kidney damage has now become kidney disease. It has taken me this long to relieve edema. Have had several transfusions and now need a kidney hormone shot every two weeks so that I can make blood from iron.

Posted by
New Jersey
on
She never had signs of heart failure, taking Avandia for almost a year. Had successfully managed type II diabetes for 20 years prior to taking Avandia.

Posted by
North Carolina
on
I began taking Avandia in 2000 for type 2 diabetes. Within 3 months I started having chest pain and problems breathing. I will mention here that I did have a stent placed prior to taking Avandia in 1999. I reported this to my doctor. He increased my dosage and the complications were getting worse. In 2003 I switched doctors and was taken off Avandia immediately and put on insulin. This doctor closed his doors and disappeared, can't find him anywhere.

I was put on Social Security Disability in 2005 for a combination of complications from diabetes including heart disease.

The symptoms never went away. I was operated on in March of 2007 and had a quadruple bypass with some areas of my heart damaged and nothing can be done for those damaged areas. I was told that I will eventually have a heart attack that I may or may not survive. No one will say that it is from the Avandia, only that it is from the diabetes.

Posted by
New York
on
I have developed heart failure in February, 2007. I have been prescribed Lasix and Lisinopril for my heart failure.

I was the one who alerted both my endocrinologist and cardiologist about the recent studies of Avandia and Actos.

My endocrinologist told me "if you have a history of heart failure, stop taking Actos". Trouble is, Actos came before the heart failure!

If you begin a lawsuit on Actos, please advise me.


Posted by
New Jersey
on
99% blockage of LAD 2 stents back to back a lot of tissue damage now i have a difibulator implanted Medtronic.I was 42 trs old at the time and on ACTOS meds for I believe 4 years.

Posted by
Maryland
on
After taking the AVANDIA medication I suffered from swelling of the hands/feet, excessive weight gain, shortness of breath and was in and out of the hospital for chest pains. I discussed the above syptoms with my doctor and he iformed me to discontinue taking AVANDIA. Within a year after stop taking the medication, I had to have a triple heart bypass.

Posted by
Texas
on
Chest pains, vomiting. Had a stent placed in my heart. Activities limited. I need financial help. I took Avandia for about a year before the heart attack. Before Avandia was prescribed I had a stress test and an EKG done and both turned out good.

Posted by
Massachusetts
on
Congestive heart failure resulting in quadruple heart by-pass. still have congestive heart failure since it can not be cured.

I was perscribed Avandia in approximately October 2005 and in about 30 days I had symptoms of congestion and weakness in all areas of my body. No one would tell me what was wrong, until January 2006. February 3, 2006 I was again hospitalised for quadrupal by-pass.

Posted by
Tennessee
on
I began taking Advandia as soon as it came out. I have had open heart surgery and my heart doctors took me off the Avandia. I have been told there is an irregularity now that can cause a stroke. I believe Advandia has contributed to my heart problems.

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