|
|
|
2007-8-31 15:20:24 |
|
A popular drug called Avandia, Glimide or Rezult used worldwide by 180 million patients with type-2 diabetes may drastically increase the risk of heart attack, according to a new study published in prestigious New England Journal of Medicine. Avandia, approved in 1999 for its marketing in the United States, is a medication indicated for use in type-2 diabetes patients to control their blood sugar levels. Type-2 diabetes sufferers can't produce enough insulin from the pancreas or can't use insulin efficiently. Type 2 diabetes, a serious and life threatening disease that affects approximately 18 to 20 million people in the U.S. Diabetes is a leading cause of coronary heart disease, blindness, kidney failure and limb amputation. The results of the study show that the type-2 diabetics had a 43 percent higher risk of developing a heart attack and a 64 percent greater risk of dying from a heart attack than those who did not take the drug. The review conducted by Dr. Steven Nissen of the Cleveland Clinic was based on data from 42 clinical trials in which 27,000 type-2 diabetes patients were given Avandia. Dr. Nissen says patients began having heart problems in the first six months of taking the drug. "That is alarming," said Nissen in an interview with the Voice of America (VOA). "It needs to be confirmed with other analyses, but if the data hold up, and I believe that they will hold up, it does represent a huge public health concern." The Journal's editors indicated that Avandia should not have been put on the market, calling the approval of Avandia by the U.S. Food and Drug Administration and its release by the manufacturer GlaxoSmithKline "a major failure of the drug use and drug approval process in the United States," VOA reports. Dr. David Nathan of Massachusetts General Hospital in Boston, Massachusetts said tha the problem could have been avoided if the FDA did a closer study like Dr. Nissen did,. "Both the [Food and Drug Administration] and the drug company presumably had this data in hand," says Dr. Nathan. "So why didn't they ever look at it the way Dr. Nissen and his colleagues did?" The FDA says it has been aware of the problems as data from the study was reportedly presented to the Food and Drug Administration almost a year ago. But the federal food and drug regulator has not taken action earlier. Dr. Robert Meyer of the FDA is quoted by the VOA as explaining, "We want to be proactive about safety, but we also don't want to needlessly disrupt the diabetic care of hundreds of thousands or millions of diabetic patients." "FDA is carefully weighing several complex sources of data, some of which show conflicting results, related to the risk of heart attack and heart-related deaths in patients treated with Avandia," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research. "We will complete our analyses and make the results available as soon as possible. FDA will take the issue of cardiovascular risk associated with Avandia and other drugs in this class to an Advisory Committee as soon as one can be convened." GlazoSmithKline disclosed the adverse effects associated with Avandia. The drug can stimulate extra body fluid, leading to swelling and weight gain. It can also increase LDL cholesterol levels by as much as 18 percent, increasing risk of heart disease. GlaxoSmithKline stands by its drug, according to VOA. The FDA did not seem to accept the notion that taking Avandia would definitely result in high risk of heart attack. The agency states on its website that "the FDA has not confirmed the clinical significance of the reported increased risk of ischemic cardiovascular events in the context of other studies." The FDA has not asked Glaxo to take any action because it believes that switching therapies for diabetcs also carries risks. Nevertheless, "the FDA has updated the product's labeling on several occasions to reflect these new data, most recently in 2006.? said (source). “The most recent labeling change for Avandia also included a new warning about a potential increase in heart attacks and heart-related chest pain in some individuals using Avandia. This new warning was based on the result of a controlled clinical trial in patients with existing congestive heart failure." U.S. Congressional hearings are scheduled to investigate how Avandia got approved and to determine whether use of Avandia for type-2 diabetes is worth the increased risks. The following is cited from the FDA which prepared the document in 2006. Patient Information Sheet Rosiglitazone (marketed as Avandia) This is a summary of the most important information about Avandia. For details, talk to your healthcare professional. What is Avandia used for? Avandia, in addition to diet and exercise, improves blood sugar control in adults with type 2 (non-insulin-dependent) diabetes. Avandia can be used alone or in combination with a sulfonylurea, metformin, or insulin. Avandia can also be used in addition to a sulfonylurea plus metformin when diet, exercise, and both agents are not enough to control blood sugar. Who should not take Avandia? Do not use Avandia for type I diabetes (juvenile diabetes) or diabetic ketoacidosis. If you have heart failure, fluid retention, or active liver disease your healthcare provider will evaluate you to decide if Avandia is right for you. General Precautions with Avandia: Avandia is in the same class of drugs as Rezulin, which has been associated with rare but serious liver injury, including liver failure leading to transplant or death. Because Avandia’s liver safety profile is not fully determined yet, your doctor will do blood tests that evaluate your liver before starting you on Avandia. These blood tests should be repeated every two months for the first year, then regularly after that. Call your healthcare provider right away if you develop nausea, vomiting, stomach pain, a feeling of tiredness or having no energy, loss of appetite, dark urine, or jaundice (yellow coloring of eyes and skin). These may be symptoms of liver problems. Patients who experience an unusually rapid increase in weight or retain fluid (edema) or who develop shortness of breath or other symptoms of heart failure while on Avandia should immediately report these symptoms to their healthcare provider. Call your doctor if you develop visual symptoms, such as decreased vision or blurry vision, while taking Avandia. Some patients have developed macular edema (a swelling in the back of the eye) while taking Avandia. All patients with diabetes should have eye examinations regularly, no matter what medicine(s) they are taking for diabetes.. When taking Avandia with other oral diabetes medicines, there is a risk of your blood sugar becoming dangerously low. Ask your healthcare provider about symptoms of low blood sugar, conditions that make low blood sugar more likely, and what to do if you get it. Make sure to explain to family members. If you are a woman who has not reached menopause but have not had menstrual periods, you may become pregnant unless you use an effective method of birth control. Avandia, like other drugs in this class, may cause insulin resistant women to start ovulating again. Women should tell their doctor if they notice any changes in their monthly menstrual cycle. During periods of stress on the body, such as fever, trauma, infection, or surgery, your medication requirements may change; contact your healthcare provider promptly. Managing your diabetes should include diet control. Caloric restriction, weight loss as needed, and exercise are essential for the proper treatment of diabetes because they help improve insulin sensitivity and the effectiveness of drug therapy. What should I tell my doctor or healthcare provider? Tell your healthcare provider if you are trying to become pregnant, are already pregnant, or are breast-feeding. Because certain other medication may interact with Avandia, review all medications that you are taking with your healthcare provider, including those that you take without a prescription. What are some possible side effects of Avandia? (This list is NOT a complete list of side effects reported with Avandia. Your healthcare provider can discuss with you a more complete list of side effects.) cough or cold headache inflammation of the sinuses back pain swelling or fluid retention Reports of Patients? Experiences After Avandia Became Available: There have been reports of inflammation of the liver (hepatitis) and elevated liver enzymes. It has not been determined whether these events are directly related to Avandia. It is recommended that patients taking Avandia have their liver enzymes monitored periodically. For more detailed information about Avandia, ask your healthcare provider. For more information, read http://www.fda.gov/cder/foi/label/2007/021071s023lbl.pdf |
