The adverse effects of medicines can lead to lifetime health issues for people of all ages. Therefore, anyone seeking medical help should be aware of the Food Drug Administration (FDA) restrictions on medicines and treatments. According to the FDA, some medicines can be harmful to certain patients, who have been suffering from specific health problems. Avandia is one such medicine that has created huge controversies in the past few years. One can search online for the Yourlawyer Avandia lawsuit to know more about this issue. Here are some important facts at a glance.
- What is Avandia?
Manufactured and marketed by GlaxoSmithKline, Avandia is an oral antidiabetic medication. This medicine is prescribed to patients suffering from type 2 diabetes. Avandia controls blood sugar levels by increasing insulin sensitivity and diminishing circulating insulin levels in the body’s cells. While this medicine has been proven to control blood sugar levels when taken concomitantly with diet and exercise, it can give rise to other problems in the body.
- History of Avandia:
With approval from the Food and Drug Administration in 1999, Avandia came to the medical market. Since then, physicians have been prescribing medicine to people with type 2 diabetes. However, in 2006, the manufacturer GlaxoSmithKline provided information that the medicine can cause fluid buildup and protein buildup in the eye due to its generic version rosiglitazone. The FDA made further investigation and in 2007, it asked GlaxoSmithKline to mention additional information about side effects in the Avandia Black Box Warning label. The FDA’s report indicated heart failure as a side effect of this medicine.
In 2008, a study conducted by Harvard University showed that almost 15 percent of patients who have been taking Avandia are at a greater chance of dying. Moreover, 13 percent of the patients are at a greater chance of suffering congestive heart failure. Two years later, more than $2 billion in litigation costs and settlements were charged from GlaxoSmithKline by the European regulators. The panel decided that GlaxoSmithKline should issue new warning labels and restrictions to regulate the drug further.
- Avandia Heart Attacks Lawsuits:
In 2010, the Food Drug Administration (FDA) placed further restrictions on Avandia. The medicine was only allowed to specific patients, who belonged to any of the two categories. The first category included patients who were made aware of Avandia cardiac side effects. The second category included patients and doctors who could attest that they have tried every other diabetes medicine but got no help.
Yourlawyer Avandia lawsuit mentions that there are chances of severe health problems from Avandia dosage. Anyone suffering from such side effects should consult a defective drug lawyer to claim compensation from the manufacturer. This lawsuit also mentions that rosiglitazone, the active ingredient in Avandia is also available in combination with other diabetes medications. The FDA is going to apply newly-imposed restrictions on those companies very soon.
To study the cardiovascular safety of Avandia compared to other diabetic drugs, the FDA ordered GlaxoSmithKline to arrange an independent group of scientists, who will review the key aspects of the company’s clinical trial known as RECORD. In 2009, RECORD was released and it did not find any proof of increased heart risks. The report was widely criticized among researchers across the nation for being contradictory to every other study report.
In 2010, the FDA stated that RECORD was inadequately designed. The FDA review of RECORD found several instances in which cases of heart problems were ignored by RECORD. Based on the FDA’s report, victims of Avandia heart attacks may be eligible to receive compensation for the below conditions.
- Medical Bills
- Lost Wages
iii. Pain and Suffering
- Other Damages
However, a study conducted by Dr. David Graham of the FDA CDER found that patients in the U .S. Medicare system who took Avandia may have suffered about 48,000 heart attacks, strokes, and other problems between 1999 and 2009. The study involved 227,500 patients. The result was shocking. Among all the patients who took Avandia,
- 27 percent were more likely to suffer a stroke
- 25 percent were more likely to develop heart failure
- 14 percent were more likely to die
Moreover, a follow-up to the 2007 Cleveland clinic analysis looked at 56 clinical studies involving 35,500 patients, including RECORD. It showed that the risk of heart problems had increased up to 28 percent. One can know more about the Yourlawyer Avandia lawsuit by exploring personal injury or defective drug lawsuits.
- Precautions before Taking Avandia:
Rosiglitazone (Abilify) can be harmful to many patients if they have allergies or other adverse reactions to glitazones like pioglitazone. Most physicians evaluate a comprehensive medical history of their patients to ensure they do not have the health issues mentioned below.
- Heart disease
- Liver disease
- Heart attacks
- Congestive heart failure
- Edema (swelling)
- Fluid in the lungs
- Retinal (eye) problems
- Other bone issues
The patients should cooperate with their physician in the process of case history evaluation. This step is crucial as it helps the doctors to determine a suitable medicine that does not cause any harm to them. In this context, the doctors also mention that adverse reactions such as drowsiness, dizziness, or blurry vision after intake of this medicine might happen. For those patients, the doctors suggest not to be involved in machinery, driving, or performing any activity requiring clear vision or alertness right after the intake of Avandia.
Anyone suffering from Avandia side effects should consult with Avandia lawyers at the earliest. The expert attorneys can help them file a lawsuit and get compensation from the manufacturer for any health problems that occurred from the drug. Avandia lawyers are the legal professionals, usually defective drug lawyers, who have specialized in Avandia lawsuits. They can make their clients aware of the Yourlawyer Avandia lawsuit as well. As the lawyers have extensive knowledge and experience to deal with these cases, they will be able to bring justice to the victims and their families. Many people have already received compensation by taking legal help.