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Avandia

The Avandia injury attorneys at the Drug Law Center have filed monetary compensation lawsuits on behalf of our clients that have suffered from side effects caused by the diabetic treatment medication.

Introduction

Avandia RecallAvandia (rosiglitazone) is a diabetic medication taken orally to increase insulin sensitivity and diminish circulating insulin levels while enhancing glycemic control. However, the drug has been linked to the development of severe side effects where patients taking the medication have experienced higher heart failure incident rates and a greater potential of developing liver problems. In 2006, physicians were alerted by the drug maker GlaxoSmithKline revealing that Avandia and its generic version rosiglitazone produced two different forms of edema including fluid buildup and protein buildup in the eye. The following year, the FDA forced GlaxoSmithKline to include additional information in the Avandia Black Box Warning label to include the overwhelming evidence of an increased risk of developing heart failure.

History of Avandia

Marketed by GlaxoSmithKline, today there is an estimated 60 million prescriptions written my doctors in the U.S. Avandia was first brought to the medical market back in 1999 after being approved by the Food and Drug Administration. every year. In 2008, Harvard revealed a study involving approximately 30,000 individuals and concluded that there was a 15 percent greater chance of dying and a 13 percent greater chance of suffering congestive heart failure after taking the medication compared to patients who were taking Actos.

In 2010, European regulators stop the sales of Avandia due to the increased rate of potential heart risks, costing GlaxoSmithKline more than $2 billion in litigation costs and settlements that year. At that time, the advisory panel for the Food and Drug Administration met and considered removing Avandia from the medical marketplace. However, the panel decided that GlaxoSmithKline would need to issue new warning labels and restrictions on prescribing the drug.

Precautions Before Taking the Medication

It is important to discuss any allergies the patient knows they have before taking rosiglitazone (Abilify) or any other adverse reaction to glitazones like pioglitazone. These products contain many inactive ingredients that are known to produce allergic reactions or other serious problems. Before the doctor will prescribe the tests they usually require a comprehensive medical history to determine if the patient has suffered from heart disease, liver disease, heart attacks, angina, or congestive heart failure. The doctor also looks for a history of edema (swelling), fluid in the lungs, retinal (eye) problems, anemia, osteoporosis, or other bone issues.

Mild drug interactions and adverse reactions might include drowsiness, dizziness or blurry vision caused by extremely high or low blood sugar levels. Doctors recommend that when these side effects occur that the patient should avoid using machinery, driving, or performing any activity requiring clear vision or alertness.

Patients, especially females, should discuss the potential risk of suffering a bone fracture when taking Abilify (rosiglitazone) including if the woman is pregnant or is considering pregnancy. This is because there are significant risks that could occur during pregnancy and research is yet to determine if the drug passes through the mother’s breast milk to the baby.

Drug Interactions

The patient may increase their potential for developing severe side effects if there is a drug interaction, especially with insulin, after taking the medication. The patient should talk with their physician to discuss all the medications they are currently taking. This includes beta blocker drugs like glaucoma eyedrops (timolol), propranolol, and metoprolol.

These beta blockers are known to prevent pounding/fast heartbeats that are typically felt during hypoglycemia events when blood sugar levels fall exceedingly low. Additional interaction symptoms might include sweating, hunger, and dizziness. Any drug that interacts with Abilify (rosiglitazone) often makes it a challenge to control blood sugar levels.

Avandia Side Effects

Classified as a thiazolidinedione anti-diabetic medication, Avandia (rosiglitazone) is to be used concomitantly with healthy exercise and diet as an effective solution for glycemic control in individuals who are suffering from type II diabetes mellitus. The product is not effective for individuals with Type I diabetes mellitus because it is activated only when there is the presence of endogenous insulin.

Contraindications for taking Avandia (rosiglitazone) include those with a history of a hypersensitivity reaction to the medication or any of the ingredients formulated into the drug. GlaxoSmithKline has issued warnings and precautions involving most serious side effects that include:

  • Cardiac Failure – Avandia, when taken alone or used concomitantly with another anti-diabetic medication, can cause significant fluid retention. Over time, the retained fluid condition can exacerbate and cause heart failure. A year-long placebo-controlled double-blind echo cardio trial with 224 patients suffering from Type II diabetes mellitus had an increased rate of cardiovascular events when being treated with Avandia.
  • Major Adverse Cardiovascular Events – Results from control but randomized short-term clinical trials involving Avandia use revealed an increased risk of myocardial infarction when compared to patients who took a placebo.
  • Edema – Research studies revealed that patients suffering from edema should be cautious when taking Avandia because of a statistically significant increase in median plasma by when compared to patients taking a placebo.
  • Weight Gain – Patients taking Avandia alone or concomitantly with another hypoglycemic dedication had noticeable dose-related weight gain. The study indicates that this is likely the result of a combination of fat accumulation and fluid retention.
  • Hepatic Effects – Studies reveal that doctors should initiate the measurement of liver enzymes prior to placing patients on Avandia and then test the enzymes periodically afterward. If hepatic dysfunction developed, the patient will likely experience unexplained fatigue, abdominal pain, vomiting, anorexia, nausea, and/or dark urine.
  • Macular Edema – Some diabetic patients have reported experiences with macular edema that seem to diminish one’s the medication is discontinued. The condition is known to be caused by a buildup of fluid in the macula in the center of the eye’s retina. The edema causes thickening and swelling and distorts the patient’s vision.
  • Bone Fractures – Long-term trials involving female patients taking Avandia (rosiglitazone) can increase the incident rate of bone fractures that tend to occur in the foot, hand, and upper arm. Research results revealed that the fracture sites tend to be different compared to postmenopausal -related osteoporosis that tends to break bones in the spine and hip.
  • Blood Glucose Control and Diabetes – Patients taking Avandia concomitantly with another hypoglycemic medication might have an increased potential for developing hypoglycemia. The research recommends periodic fasting blood glucose measurements to monitor therapeutic responses.

The packaging warning labels on Avandia reveal that the product produces serious side effects. Patients should avoid taking the medication if they had had previous experience with heart failure, shortness of breath, swelling (edema), or excessive weight gain. If the patient is experiencing serious side effects they should seek immediate medical attention. This includes fluid retention, swelling of the legs or ankles, unusual tiredness, a fast-increasing weight gain, or difficulty breathing, especially when lying down.

For now, the FDA has made the decision that the medication is safe enough to be used in the medical marketplace. However, the history of Avandia and its generic form rosiglitazone have financially hurt GlaxoSmithKline and injured patients. The clinical community and regulators have raised many questions concerning the safety and efficacy of the product. American regulators have yet to recognize the evidence of harm versus benefits of using the Type II diabetes treatment medication like regulators in Europe who have chosen to recall the drug.

Europe Recalls Avandia

Even though the Food and Drug Administration has refused to recall the diabetic medication in 2010 but instead placed heavy restrictions on prescribing the medication, Europe suspended sales of Avandia at that time. It was the decision of the EU agency that the risks of using the Type II diabetic treatment medication more than outweigh the benefits of taking the drug.

In November 2013, the FDA removed its restriction of drugs containing rosiglitazone including Avandia, Avandaryl, Avandamet and their generic versions. They make this determination because they believe that research indicated there was no increased potential risk of developing heart attacks when taking this medication compared to another standard Type II diabetes medicines including sulfonylurea and metformin. The FD made modifications to their program to remove the restriction on the distribution of the drug and suggested that it be used concomitantly with exercise and diet as an effective way of controlling blood sugar levels in individual suffering from Type II diabetes mellitus.

Removing the restriction on patients, pharmacies and health care professionals will allow the drug to be prescribed, dispensed, and used. The FDA is recommending that training be given to healthcare professionals to understand the concerns involving potential cardiovascular risks associated with rosiglitazone drugs.

Avandia Lawsuits

GlaxoSmithKline agreed to pay $3 billion to the US government in 2012 to settle numerous Avandia lawsuits. An additional $9 million was paid in 2013 to 38 states to settle numerous state filed lawsuits. As of 2013, thousands of Avandia lawsuits were filed in state and federal courthouses. Most of those suits were resolved when the drug maker put up $2.6 billion against earnings to cover litigation involving Paxil and Avandia.

The pharmaceutical company never admitted wrongdoing and continue to maintain that their drug did not increase the potential risk of developing heart disease even though most of the plaintiffs had claimed to suffer commonly recognized Avandia-related side effects.

Many of the more than 50,000 Avandia lawsuits that have been filed by personal injury attorneys who specialize in product liability defective drug compensation claims are built on GlaxoSmithKline’s failure to warn the public, doctors, and patients of the dangerous medication. These lawsuits allege that the drug maker failed to test their drug properly and concealed or withheld pertinent information on the products safety issues. Because the pharmaceutical company could be held legally liable for the damages patients endured, many of these financial recompense cases have been successfully resolved through an out-of-court settlement involving a defective product liability lawsuit or through a jury trial award.

Receive Monetary Compensation for Your Avandia Lawsuit

The Avandia injury attorneys at the Drug Law Center are currently investigating claims and accepting cases where victims have been injured by the Type II diabetic treatment medication. Many of our clients have suffered congestive heart failure, heart attacks, bone fractures and even death. In addition, there are potential class-action lawsuits involving Avandia, rosiglitazone, and other diabetic treatment drugs.

If you have suffered injury or loss a loved one who was taking Avandia, contact our law firm today. Let us begin the process of resolving your case to ensure your family receives the financial compensation they deserve. We offer initial case consultations free of charge and will postpone payment of our legal services through our “No Win/No Fee” guarantee. If we fail to successfully resolve your case by negotiating a settlement out of court or winning your case at trial, you owe us nothing.

Sources:
http://www.drugs.com/pro/avandia.html
https://www.nlm.nih.gov/medlineplus/druginfo/meds/a699023.html
http://www.nejm.org/doi/full/10.1056/NEJMoa072761

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