Avandia Injuries

Synopsis of Prescription Drug Litigation

On May 21, 2007, the Food and Drug Administration issued a public safety alert about the diabetes drug Avandia, warning users of the greatly increased risk of heart failure in people taking the drug. The notice came on the heels of a New England Journal of Medicine study, which found people who took the drug had a 43% increase in the risk of heart attack and a 64% increase in the risk of death from all cardiovascular causes.

The FDA also ordered Avandia's maker, GlaxoSmithKline, to add a prominent "Black Box" warning to the drug's packaging to tell users about the increased risks of congestive heart failure and cardiovascular disease.

The FDA warnings also cautioned Type 2 diabetes patients who have underlying heart disease or are at high risk of heart attack to talk with their health care provider about their treatment options. Physicians and other health care providers were cautioned to closely monitor patients who take Avandia for cardiovascular risks.

Avandia® (Rosiglitazone): Manufactured by GlaxoSmithKline (GSK) and approved by the FDA in 1999, Rosiglitazone. Rosiglitazone is also sold as a combination product under the brand name Avandamet (contains rosiglitazone and metformin) and under the brand name Avandaryl (contains rosiglitazone and glimepiride). It comes in tablet form and is a member of the thiazolidinedione (TZD) class of drugs. It has recently come under scrutiny for cardiovascular risks including heart attack.

Why is this medication prescribed?: Rosiglitazone is used along with a diet and exercise program and sometimes with one or more other medications to treat type 2 diabetes (condition in which the body does not use insulin normally and, therefore, cannot control the amount of sugar in the blood). Rosiglitazone is in a class of medications called thiazolidinediones. It works by increasing the body's sensitivity to insulin, a natural substance that helps control blood sugar levels. Rosiglitazone is not used to treat type 1 diabetes (condition in which the body does not produce insulin and, therefore, cannot control the amount of sugar in the blood) or diabetic ketoacidosis (a serious condition that may occur if high blood sugar is not treated)

FDA indications: AVANDIA is a thiazolidinedione antidiabetic agent indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. It should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

What you should know before taking Avandia:

• tell your doctor and pharmacist if you are allergic to rosiglitazone or any other medications.
• tell your doctor if you are taking insulin or nitrates such as isosorbide dinitrate (Isordril, Sorbitrate), isosorbide mononitrate (Imdur, ISMO), or nitroglycerin (Nitro-BID, Nitro-Dur, Nitroquick, Nitrostat, others). Nitrates come as tablets, sublingual (under the tongue) tablets, sprays, patches, pastes, and ointments. Ask your doctor if you are not sure if any of your medications contain nitrates. Your doctor will probably tell you not to take rosiglitazone if you are taking these medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: gemfibrozil (Lopid), other medications for diabetes, montelukast (Singulair), and rifampin (Rifadin, Rimactane, in Rifamate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section or diabetic eye disease such as macular edema (swelling of the back of the eye); or liver disease. Also tell your doctor if you have ever taken troglitazone (Rezulin, no longer available in the United States), especially if you stopped taking it because you experienced side effects.
• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking rosiglitazone, call your doctor. Do not breastfeed while you are taking rosiglitazone.
• if you have not yet experienced menopause (change of life; end of monthly menstrual periods) you should know that rosiglitazone may increase the chance that you will become pregnant even if you do not have regular monthly periods or you have a condition that prevents you from ovulating (releasing an egg from the ovaries). Talk to your doctor about methods of birth control that will work for you.
• if you will be having surgery, including dental surgery, tell the doctor or dentist that you are taking rosiglitazone.
• ask your doctor what to do if you get sick, develop an infection or fever, experience unusual stress, or are injured. These conditions can affect your blood sugar and the amount of rosiglitazone you may need.

What other information should I know when taking Avandia?

• Keep all appointments with your doctor, your eye doctor, and the laboratory. Your doctor will probably order regular eye examinations and certain laboratory tests to check your body's response to rosiglitazone. Your blood sugar and glycosylated hemoglobin should be checked regularly to determine your response to rosiglitazone. Your doctor may also tell you how to check your response to rosiglitazone by measuring your blood or urine sugar levels at home. Follow these directions carefully.
• You should always wear a diabetic identification bracelet to be sure you get proper treatment in an emergency.
• Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
• It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies

Black Box  Warning:

Lawsuits: The Guardian reports lawsuits over the drug could total anywhere from $1 billion to $6 billion. This is based on research by analysts for UBS, who say 13,000 suits have been filed Included among those suing: Santa Clara County, California, which claims to have spent $2 million on rosiglitazone between 1999 and 2007 at its public hospital and is asking for "triple damages". In May 2010, GlaxoSmithKline (GSK) reached settlement agreements for some of the cases against the company, agreeing to pay $60 million to resolve 700 suits. In July 2010, GSK reached settlement agreements to close another 10,000 of the lawsuits against it, agreeing to pay about $460 million to settle these suits. In a statement, Michael Miller, the attorney representing 1,500 patients in the suit, said about the settlement "It's a compromise that allows both sides to put this behind them and move on.

When to call the Venardi Law Firm: Avandia (rosiglitazone) has many adverse side effects and contraindications. If you are experiencing any of the more severe or permanent side effects described below, you should call the Venardi Law Firm for a free consultation. We will be able to evaluate the strength of your case and determine whether you should file a lawsuit. We take cases on a contingency basis if we feel your case is strong.

Heart Disease

Some studies conclude that rosiglitazone increases fatalities from heart disease, but other studies do not. A study in 2007 has been widely cited as finding that Avandia may increase the risk of heart attack by as much as 43%. On February 20th 2010, U.S. Senators Max Baucus and Charles Grassley alleged in a report that, “Glaxo Smith Kline was aware for years that Avandia could cause heart damage, but deliberately downplayed the scientific findings regarding the safety of the drug.” (CBS News) The same Senate report claimed that Glaxo Smith Kline executives attempted to intimidate independent physicians, and formulated strategies to minimize, or misrepresent findings that Avandia may increase cardiovascular risk. In September 2010, the FDA announced that “Avandia would remain on the U.S. market, but its use would be tightly restricted.” (USA Today)

In February 2010, David Graham, the FDA's associate director of drug safety, recommended rosiglitazone be taken off the market. Graham argued that rosiglitazone caused 500 more heart attacks and 300 more heart failures than its main competitor. At the same time, a report by the Senate Finance Committee accused GlaxoSmithKline of knowing about the drug's risks well before they became public. The report also criticized the FDA for letting clinical trials continue, despite 83,000 heart attacks from 1999 to 2007 that the FDA linked to rosiglitazone. GlaxoSmithKline maintains the drug is safe and that the Senate report did not consider scientific evidence or the company's efforts to make known its concerns to the parties involved. However, the FDA still recommends patients continue taking it unless their doctor tells them otherwise.

In June 2010, David Graham, et al., published a retrospective study of 227,571 elderly American patients, comparing roziglitazone to pioglitazone (ActosÒ), the other thiazolidinedione marketed in the United States. The authors concluded rosiglitazone was associated with "an increased risk of stroke, heart failure, and all-cause mortality and an increased risk of the composite of AMI, stroke, heart failure, or all-cause mortality in patients 65 years or older".The number needed to harm with roziglitazone was sixty.

Stroke

Avandia has been linked to stroke. In some studies, it was found that the drug increases the risk of stroke by over 27%.
A study found that Avandia increases risk of stroke more than alternative drug Actos in elderly patients

Bone Fractures

GlaxoSmithKline reported a greater incidence of fractures of the upper arms, hands and feet in female diabetics given rosiglitazone compared with those given metformin (GlucophageÒ) or glyburide (MicronaseÒ) The information was based on data from the ADOPT trial. The same increase has been found with pioglitazone (Actos), another TZD.

Eye Damage

Both rosiglitazone and pioglitazone have been suspected of causing macular edema, which damages the retina of the eye and causes partial blindness. Blindness is also a possible effect of diabetes, which rosiglitazone is intended to treat. One report documented several occurrences and recommended discontinuation at the first sign of vision problems.

Hepatotoxicity (liver damage)

Moderate to severe acute hepatitis has occurred in several adults who had been taking the drug at the recommended dose for 2–4 weeks. Plasma rosiglitazone concentrations may be significantly increased in patients with pre-existing hepatic impairment.