Avandia
Avandia
Bailey Perrin Bailey is no longer accepting Avandia cases.
Avandia Side Effects/Legal Information
Studies have confirmed that the popular diabetic drug Avandia (known generically as Rosiglitazone) is linked to a number of serious and life threatening cardiac risks and consequences. The lawyers at Bailey Perrin Bailey are determined to get justice for all the victims hurt by the diabetic drug Avandia. If you or a loved one has suffered an Avandia-related heart injury, please contact us immediately for a free evaluation before it is too late. Our lawyers will work tirelessly to try and get you the compensation you deserve.
Avandia Information
Avandia is a member of class of drugs called thiazolidinediones, or TZDs. It was approved by the US Food and Drug Administration in 1999. It was released by GlaskoSmithKline (GSK) for the treatment of Type 2 diabetes as either a stand-alone medication or in combination with metformin (Avandamet) or with glimepiride (Avandaryl).
Diabetes is a crippling disease and if not properly monitored and/or treated may lead to irreparable damage to many body organs and systems. Doctors often refer to this as “end-organ damage” because diabetes can potentially affect nearly every organ system in the body. People with diabetes are at higher risk for heart attacks, kidney problems, blindness and other serious complications.
Since Avandia’s inception the drug has been prescribed to millions of Americans, and generated as much as $3.2 billion in sales, as of 2006 and $1.19 billion as of 2009. Experts believe Avandia is responsible for tens to hundreds of thousands of cardiovascular problems in the U.S. from 1999 to 2009.
- Myocardial Infarction (a/k/a Heart Attack)
- Congestive Heart Failure, Edema, and Fluid Retention
- Cerebral Vascular Disease (a/k/a Stroke)
- Other Myocardial Ischemic Related Events
The Controversy Surrounding Avandia
In 2007, more than eight years after the Avandia was first introduced onto the market, a study conducted by Dr. Steven Nissen at the Cleveland Clinic made public the serious heart risks associated with Avandia. Dr. Nissen analyzed data that was handed over to the FDA in 2005. The data suggested taking Avandia significantly increased the risk of heart attacks and heart related deaths by over 40% and 60%, respectively. Dr. Nissen’s study was published in the New England Journal of Medicine (NEJM), a well respected peer reviewed medical journal. Largely as a result of this study, in 2007 the FDA reevaluated Avandia and confirmed Nissen’s findings. Nissen’s study further spurred a Senate Finance Committee investigation into Avandia and its side effects. The two year investigation culminated in a 342 page report on Avandia that concluded that there was sufficient evidence to suggest that GSK was aware of the association between Avandia and cardiac risks several years prior to Nissen’s study becoming public. Evidence reviewed even suggested that GSK knew or at least should of have known of the risks possibly even as early as 1999, almost as soon as the drug was approved by the FDA. The Senate’s report further argued that the company had a duty to sufficiently warn patients and the FDA of its concerns. Instead, the report indicates “GSK executives intimidated independent physicians, focused on strategies to minimize findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that the rival drug ACTOS (pioglitazone) might reduce cardiovascular risk.”
Avandia Black Box Warning
The immediate aftermath of Nissen’s research resulted in the FDA mandating that a strengthened “black box warning” be included on Avandia packaging to warn of the significant increased risk of heart attacks and heart-related chest pain. A “black box warning” is the strongest safety warning issued by the FDA. It is so named for their black borders that surround the text of the warning. It is a type of warning that typically appears on prescription labels or in literature describing it, like a packet inserts. These warnings indicate that medical studies, clinical trials, and other related literature have found a statistically significant risk of serious or life-threatening side effects associated with a drug.
FDA Restrictions on Avandia Use
As recently as September 2010, the FDA placed stringent restrictions on the use of Avandia because of a heightened risk of heart attacks associated with the drug. Avandia is restricted to those patients with Type 2 diabetes that cannot control their diabetes on other medications.
Avandia Settlements
As of July 2010, GSK has set aside $460 million to settle lawsuits filed by some 10,000 Avandia patients (an average of over $40 thousand per plaintiff) and thousands of more injured patients are gearing up to sue GSK over Avandia.
Who Should Not Take Avandia?
In light of the FDA’s restrictions on the use of Avandia, only take Avandia if no other diabetic medication works to control your Type 2 diabetes.
Do not take Avandia if you:
- Have Type 1 diabetes or if you are in a state of diabetic ketoacidosis.
- Have heart failure or other heart problems or are on any medicines for high blood pressure, high cholesterol or heart failure, or for prevention of heart disease or stroke.
- Take nitrates or insulin. Taking Avandia with insulin or with nitrates is not recommended.
- Have a type of diabetic eye disease called macular edema.
- Have liver problems or had liver problems while taking REZULIN (troglitazone).
- Are pregnant or planning to become pregnant. Avandia should not be used during pregnancy. It is not known whether Avandia can harm an unborn baby.
- Are breastfeeding or planning to breastfeed. It is not known if Avandia passes into breast milk or if it could harm a nursing baby. You should not use Avandia while breastfeeding.
- Are a premenopausal woman who does not have regular monthly periods, Avandia may increase the risk of pregnancy.
Are There Any Interactions With Drugs or Foods?
Avandia may interact with other medicines causing blood glucose dysregulation which can be dangerous. Tell your healthcare professional about all medicines (prescription and non-prescription), vitamins, and herbal supplements you take. Avoid taking alcohol while taking Avandia. It can lower your blood sugar. The list below is by no means complete and other drugs may interact with Avandia. Please consult your health care professional before beginning any new medication.
Avandia with the following drugs may raise blood sugar levels and you may be more likely to have hyperglycemia: isoniazid; diuretics (water pills); steroids (prednisone and others); phenothiazines (Compazine and others); thyroid medicine (Synthroid and others); birth control pills and other hormones; seizure medicines (Dilantin and others); and diet pills or medicines to treat asthma, colds or allergies.
Avandia with the following drugs may lower blood sugar levels and you may be more likely to have hypoglycemia: nonsteroidal anti-inflammatory drugs (NSAIDs); aspirin or other salicylates (including Pepto-Bismol); sulfa drugs (Bactrim and others); a monoamine oxidase inhibitor (MAOI); beta-blockers (Tenormin and others); or probenecid (Benemid).
Some medications may interact with Avandia. Tell your doctor if you are using any of the following drugs: gemfibrozil (Gemcor); rifampin (Rifater, Rifadin, Rimactane); or a nitrate drug for chest pain or heart problems, such as nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid, and others), isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), or isosorbide mononitrate (Imdur, ISMO, Monoket).
Read more: http://www.drugs.com/avandia.html
Avandia Side Effects
All medications have the potential to cause side effects, including Avandia. However, not everyone who takes the drug will experience problems and those that do, the side effects can vary from mild to severe. If a problem persists or becomes bothersome contact your health care provider and seek immediate assistance.
Some of the more common side effects include, but are not limited to the following: upper respiratory infections (cold-like symptoms); headaches; weight gain; back pain; anemia (low red blood cell count); bone fractures especially in women; hypoglycemia (low blood sugar), with symptoms of nervousness, sweating, intense hunger, trembling, weakness, or palpitations.
Some of the more serious side effects include, but are not limited to the following: trouble breathing (it may be a sign of new or worsening congestive heart failure), even with mild exertion; heart attack (myocardial infarction); stroke; angina (severe chest pain) or heavy feeling, pain spreading to the arm or shoulder, sweating, general ill feeling; severe allergic reaction; liver problems (nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes)); swelling or rapid weight gain; swelling, especially in the legs or ankles; blurred vision; increased thirst or hunger, urinating more than usual; or pale skin, easy bruising or bleeding, weakness.
Avandia Related Heart Injuries/Side Effects
AVANDIA MAY CAUSE OR WORSEN CERTAIN HEART PROBLEMS (CONGESTIVE HEART FAILURE, HEART ATTACK, STROKE). SEEK IMMEDIATE ATTENTION IF YOU NOTICE ANY SYMPTOMS OF HEART PROBLEMS, INCLUDING: SWELLING OF THE HANDS/FEET, UNUSUAL/SUDDEN WEIGHT GAIN, TROUBLE BREATHING, AND CHEST PAIN/DISCOMFORT.