Stroke - Consumer Justice Foundation

Stroke and Avandia

Avandia is an anti-diabetic medication which belongs to a class of drugs called thiazolidinediones. These drugs function by increasing the body’s sensitivity to insulin, thereby helping the body control the amount of sugar in the blood. Avandia (rosiglitazone) was approved by the FDA in 1999, strictly for the treatment of Type 2 diabetes, and is currently manufactured by GlaxoSmithKline. In the past, Avandia was considered the best-selling anti-diabetic medication in the world. Unfortunately, Avandia and GlaxoSmithKline have come under fire in recent years because of new information regarding the potentially life-threatening dangers of Avandia use. According to recent studies, Avandia may significantly increase a person’s risk of suffering severe side effects, including strokes. In fact, reports indicate that GlaxoSmithKline may have been aware of the allegedly hazardous nature of Avandia, but the company chose to withhold this information from federal drug regulators and consumers.

Stroke Described

A stroke occurs when the blood supply to any part of the brain is interrupted, typically caused by the blockage or bursting of a blood vessel in the brain. Without an adequate supply of blood, the brain cannot get enough oxygen and brain cells may begin to die, causing permanent damage. There are two major types of strokes, ischemic strokes and hemorrhagic strokes. An ischemic stroke occurs when a blood vessel carrying blood to the brain is blocked by a blood clot, while a hemorrhagic stroke occurs when a blood vessel in part of the brain becomes weak and bursts open. This causes blood to leak into the brain which can severely damage brain cells. Although strokes can occur for a variety of different reasons, the symptoms are often universal, including:

  • Sudden and severe headache
  • Changes in alertness
  • Clumsiness
  • Confusion
  • Difficulty swallowing
  • Dizziness
  • Muscle weakness (usually on one side)
  • Loss of coordination
  • Trouble speaking
  • Numbness or tingling on one side of the body

Stroke Treatment and Prognosis

It is imperative that stroke victims receive immediate medical attention in order to avoid permanent disability. In most cases, a person suffering from a stroke must reach a hospital within three hours after the symptoms begin in order for treatment to be effective. Proper medical treatment depends on the severity and the cause of the stroke, and recovery time differs on a case-by-case basis. The main goals of stroke treatment is to help the patient recover as much function as possible and to prevent future strokes. During the weeks to months after a stroke, problems with thinking, talking and moving may improve, and a number of stroke victims continue to improve in the months or years after the event occurs.

The outlook for a stroke victim depends largely on the type of stroke, what body functions have been affected, how much brain tissue was damaged, and how quickly medical treatment is received. In some cases, the victim may recover quickly, while in others the victim may experience permanent loss of function. The risk for a second stroke is highest during the first few weeks or months after a stroke occurs.

Avandia FDA Warnings and Avandia Side Effect Studies

According to FDA scientist, Dr. David Graham, as many as 100,000 strokes, heart attacks, deaths and cases of heart failure may be associated with Avandia since the drug entered the market in 1999. Graham’s study involved a review of more than 220,000 federal health program patients who started on Actos or Avandia from July 2006 to June 2009 and were followed for three years on average. According to the study, Avandia patients were 27% more likely to suffer stroke, 25% more likely to develop heart failure, and 14% more likely to die than patients taking Actos. Another study published in the New England Journal of Medicine in 2007 concluded that, compared to other anti-diabetic medications and no anti-diabetic treatment, Avandia was associated with a significant increase in the risk of heart attack and an increase in the risk of death from cardiovascular causes.

In response to startling new data regarding possible Avandia side effects, the FDA has announced a more restrictive approach in the treatment of diabetes. The agency released a statement in 2008 stating that the FDA would no longer approve anti-diabetic medications simply because they could help control blood sugar levels, which is the standard that has been in place for more than eighty years. Instead, the FDA will require drug companies to perform clinical trials lasting longer than two years in order to demonstrate their drug’s effectiveness in treating diabetes and improving quality of life, without causing life-altering damage to the heart. The FDA has required GlaxoSmithKline to change prescribing information to include amended safety information and new restrictions on the use of the drug. The revised Avandia label restricts the use of Avandia to diabetic individuals who are already taking the drug, those patients who cannot successfully control the disease with any other medications, and those who have decided not to take Actos for medical reasons.

Contact an Avandia Attorney for Help

Victims of serious injury or death resulting from the proper use of a dangerous drug are not at fault. Drug manufacturing companies like GlaxoSmithKline are responsible for the safety of their medications and should be held responsible for any adverse side effects sustained by consumers of their products. Unfortunately, this isn’t always the case. If you or a loved one has suffered from a stroke and you believe Avandia to be the cause, contact an experienced Avandia attorney to discuss the benefits of filing an Avandia lawsuit against GlaxoSmithKline. The goal of Avandia lawsuits and potential Avandia class action lawsuits is to seek financial compensation for your injuries and medical expenses, as well as the pain and suffering endured by you and your family.

While most consumers understand that no drug is 100% safe, they do expect their prescription medications to treat their condition without causing them any unnecessary harm. Unfortunately, some drugs currently on the market are connected to potential risks so serious that they may actually outweigh the possible benefits of the drug. Consumers have the right to be informed of all benefits and risks associated with their prescription medications in order to make an educated decision to continue or discontinue use of the drug. Without accurate drug information, millions of consumers may be unknowingly exposing themselves to serious harm and even death. With the help of a qualified Avandia lawyer, you can protect your rights and collect the compensation you are entitled to.

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