Avandia Drug Description

AVANDIA (rosiglitazone maleate) is an oral antidiabetic Extenzen agent which acts primarily by increasing insulin sensitivity. AVANDIA improves glycemic control while reducing circulating insulin levels.

Rosiglitazone maleate is not chemically or functionally related to the sulfonylureas, the biguanides, or the alpha-glucosidase inhibitors.

Chemically, rosiglitazone maleate is (±)-5-[[4-[2-(methyl-2532 pyridinylamino)ethoxy]phenyl]methyl]-2,4-thiazolidinedione, (Z)-2-butenedioate (1:1) with a molecular weight of 473.52 (357.44 free base). The molecule has a single chiral center and is present as a racemate. Due to rapid interconversion, the enantiomers are functionally indistinguishable. The structural formula of rosiglitazone maleate is:

The molecular formula is C₁₈H₁₉N₃O₃S•C₄H₄O₄. Rosiglitazone maleate is a white to off-white solid with a melting point range of 122° to 123°C. The pKa values of rosiglitazone maleate are 6.8 and 6.1. It is readily soluble in ethanol and a buffered aqueous solution with pH of 2.3; solubility decreases with increasing pH in the physiological range.

Each pentagonal film-coated TILTAB tablet contains rosiglitazone maleate equivalent to rosiglitazone, 2 mg, 4 mg, or 8 mg, for oral administration. Inactive ingredients are: Hypromellose 2910, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 3000, sodium starch glycolate, titanium dioxide, triacetin, and 1 or more of the following: Synthetic red and yellow iron oxides and talc.

SIDE EFFECTS:See also Warning section.

Headache or cough may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fast/pounding heartbeat, changes in menstrual cycles, bone fracture.

Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: dark urine, yellowing of eyes/skin, persistent nausea/vomiting, stomach/abdominal pain, vision changes (e.g., color or night vision problems).

This medication usually does not cause low blood sugar (hypoglycemia), but this effect may occur if you do not consume enough calories (from food, juices, fruit, etc.). The symptoms include chills, cold sweat, dizziness, drowsiness, shaking, rapid heart rate, weakness, headache, fainting, tingling of the hands or feet, or hunger. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you are in a situation where you don't have these reliable forms of glucose, eat a quick source of sugar such as table sugar, honey, or candy, or drink a glass of orange juice or non-diet soda to quickly raise your blood sugar level. Tell your doctor immediately about the reaction. To help prevent hypoglycemia, eat meals on a regular schedule and do not skip meals.

Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, or fruity breath odor. If these symptoms occur, tell your doctor immediately. Your medication dosage may need to be increased.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS:Before taking rosiglitazone, tell your doctor or pharmacist if you are allergic to it; or to other "glitazones" such as pioglitazone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Promptly talk with your doctor or pharmacist about the benefits and possible risks of this medication, even if you have been taking it for awhile, especially if you have heart problems. Do not stop taking it unless directed to do so.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: type 1 diabetes (insulin-dependent diabetes), very high blood glucose (diabetic ketoacidosis), newly diagnosed or worsening heart failure (acute congestive heart failure), history of liver disease, active liver disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease (e.g., chronic congestive heart failure, heart attack, angina), fluid in your lungs, swelling (edema), anemia, high blood cholesterol, eye (retina) problems, bone problems (e.g., osteoporosis, osteopenia).

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar levels. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely.

Limit alcohol while taking this medication because it can increase the risk of your blood sugar getting too low (hypoglycemia).

During times of stress, such as fever, infection, injury or surgery, it may be more difficult to control your blood sugar. Consult your doctor, as additional medication may be required.

This medication may increase the risk of bone fracture (upper arm, hand, foot) in female patients. To lower the chance of getting injured, use caution when doing activities such as contact sports.

This medication can cause changes in the menstrual cycle (ovulation) in women with certain fertility problems. Consult your doctor or pharmacist about the use of reliable birth control while taking this medication.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Your doctor may substitute insulin for this drug during your pregnancy. Follow all instructions carefully.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Avandia

Avandia - also known as Rosiglitazone - is a blood sugar control medication used for type II diabetes patients. Avandia has been on the market for 9 years and has been prescribed to millions of patients. Recently, studies have surfaced that bring the Avandia's safety into question. During the past year the drug has been under close scrutiny by the FDA in response to reports of increased risk of heart attack, heart failure, osteoporosis and other potentially life-threatening side effects of Avandia. 

A public safety advisory was issued in 2007 to warn Avandia patients of the cardiovascular risk associated with the drug's use. However, the FDA has not issued an Avandia recall, claiming that sufficient evidence as to the dangers versus the benefits of the the drug does not exist. Currently, Avandia's manufacturer and other researchers are conducting additional studies to determine the safety level of Avandia. In the meantime, patients across the United States have experienced adverse medical events related to the use of the drug and many have filed Avandia lawsuits.

On this website LegalView provides numerous resources on Avandia. Follow this link to learn more about Avandia. If you are seeking Avandia legal assistance, please fill out a contact form at any time. When you submit a contact form, a qualified Avandia lawyer will receive your information and contact you.

Avandia is a doctor-prescribed oral medication for glycemic control manufactured by health care company GlaxoSmithKline.  Also known as Rosiglitazone - a part of the thiazolidinedione, or "glitazone" family - Avandia works to manage blood sugar levels in type II diabetes patients. Avandia is not for type I diabetes patients, who are dependent on insulin; it is a blood sugar control medication that is meant to work in tandem with healthy diet and exercise to balance insulin levels.  At this time, Avandia is still available as a prescription medication, and is currently under continued review by the FDA. Avandia is a brand name medication and there is no generic version of Avandia on the market, although there are medications manufactured by other companies, such as Actos, that are similar in purpose and effect.  Avandia has been on the market for approximately 9 years, and an estimated 6 million people worldwide have taken or are currently taking Avandia.

In the past year or so, Avandia has come under fire for reports of cardiovascular risk. In May of 2007 the New England Journal of Medicine published a study that claimed Avandia puts users at a significantly increased risk of heart attack and other dangerous cardiac events.  This study, completed by the Cleveland Clinic, analyzed the results of 42 previous studies of Avandia involving over 27,000 patients. The results showed a 43% increase in heart attacks and a 64% increase in fatal cardiac events in patients taking Avandia versus those not taking the drug.

Following this publication, the FDA issued a public safety warning and requested a black box warning for Avandia and Actos.  A black box warning is the most serious warning the FDA can issue, requiring safety and risk information to be printed on the drug's packaging.  Despite calls to pull Avandia from the market completely, the FDA has not taken any such action.  GlaxoSmithKline claims that there is no clear and present danger to Avandia users and that the evidence from previous clinical trials is not consistent enough to draw any solid conclusions as to Avandia's potential heart risk.  GlaxoSmithKline Vitagra has been asked to complete additional studies to produce more conclusive results and is currently in the process of doing so. Read more here about Avandia and heart problems.

In addition to heart problems, Avandia has a number of other risks and side effects including osteoporosis, liver damage and vision problems.  Get more information on Avandia side effects.

On this website you will find a variety of resources providing you with information, data and assistance with your Avandia questions.  If at any time you feel that you have a legal issue in connection with Avandia, please use the form provided to contact a qualified Avandia lawyer.  A law firm in your area will be in touch with you to assess your Avandia case and provide a free consultation.

Avandia Lawyers and Lawsuits

Filing an Avandia Lawsuit

If you or a loved one has been negatively affected by the use of Avandia, you may be considering filing an Avandia lawsuit.  If so, you should also be considering a source of legal advice and assistance.  Like any lawsuit, an Avandia lawsuit involves a great deal of time and effort.  There are many steps in the litigation process and the burden of proof will be on you if your Avandia case goes to trial.  Being organized, knowledgeable, and prepared throughout your Avandia lawsuit will increase your chances of a successful outcome.  Of course, most people are not familiar with legal proceedings at all, let alone the medical issues associated with pharmaceutical cases.  That is why it is in your best interest to consult with an Avandia lawyer before proceeding with your filing.

How an Avandia Lawyer Can Help

A lawyer that is well-versed in the specific issues surrounding Avandia will be aware of the drug's history, uses, risks and side effects.  This kind of background information is essential in building a strong case against Avandia and/or the manufacturer or prescribing physician.  An Avandia lawyer will help you to understand whether your claim is valid and worth pursuing legal action before you put in significant time or money.  He will also advise you as to the best course of action to take during every step of the Avandia litigation process and help you to continually re-evaluate your case as needed.

Most importantly, an Avandia lawyer will take some of the legal burden off of your shoulders while you cope with health issues.  If you are pursuing legal action, you are most likely still dealing with the medical ramifications of taking Avandia. You need time to focus on your health and ensure that you ready for both the physical and emotional challenges of your experience with Avandia.

Finding a Good Avandia Lawyer

LegalView.com is dedicated to helping you find the best lawyer in your area for the case that you are facing.  With a network of lawyers across the United States, LegalView can assist you in finding an Avandia lawyer that has the right experience and expertise to handle your Avandia lawsuit.  Submit a contact form to be put in touch with an Avandia lawyer in your area for a free consultation.