Microsoft word - eu press release 14 nov avandia1.doc
GSK Revises US Labeling for Avandia November 14, 2007 - — GlaxoSmithKline announced today that it is implementing changes to the US product label for Avandia (rosiglitazone maleate), based on an extensive and thorough review by the FDA of myocardial ischaemiadata on rosiglitazone, the most widely studied oral anti- diabetic medicine available. The boxed warning has been revised to add the FDA’s conclusion that, while an FDA meta- analysis of short-term studies – mostly against placebo - showed an association between rosiglitazone and an increase in myocardial ischaemic events, that risk was not confirmed or excluded in three long-term clinical trials comparing rosiglitazone against both placebo and other oral anti-diabetes medicines. The box will state that the available data on the risk of myocardial ischaemia are inconclusive. The FDA has also concluded there is insufficient information available to determine whether any oral anti-diabetic medicine reduces cardiovascular risk. The FDA has directed that the sentence - “There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with rosiglitazone or any other oral antidiabetic drugs.” - will be added as a warning on the labels of all oral anti-diabetic medicines. The rosiglitazone label also has been updated to add that rosiglitazone is not recommended - though not contraindicated - for use with patients who are taking insulin or nitrates. The label summarizes the data on myocardial ischaemia to help doctors continue to evaluate which patients could benefit from taking rosiglitazone, and those for whom alternative treatment should be considered. The changes are now included in labelling for rosiglitazone in the US, and will be incorporated into future revised labelling for all approved rosiglitazone-containing products, i.e. Avandamet (rosiglitazone maleate and metformin hydrochloride), and Avandaryl (rosiglitazone maleate and glimepiride). GSK is also preparing a Medication Guide to help educate US patients about potential benefits and risks and to provide other information on rosiglitazone. “Avandia remains a valuable medicine for many patients with type 2 diabetes, and when used according to the labelling, has a well described and appropriate safety and efficacy profile,” said Dr. Ronald Krall, GSK Chief Medical Officer. “Given the severity of this disease and the importance of rosiglitazone in helping patients manage their diabetes, we will continue to work with the FDA to conduct more studies on the safety and benefits of our medicine.” As previously stated by GSK, two long-term trials in patients with diabetes comparing rosiglitazone to other oral anti-diabetic medicines show no increased risk for cardiovascular events compared to other commonly used medications, other than the well-known risk of congestive heart failure with TZDs. One trial – ADOPT - shows no increased myocardial ischaemic risk compared to metformin or sulfonylurea. The interim results of a second long-term trial – RECORD - also show no increased risk of major cardiovascular events (death, heart attack and stroke) between rosiglitazone and other medications; however, firm conclusions cannot be drawn because the trial has not yet been completed. The updated label includes data from ADOPT and RECORD plus a third long-term trial in people with pre-diabetes (DREAM). The combined analysis of these three studies show there was no increased risk of rosiglitazone over comparators with regard to myocardial infarction, mortality, or other non-heart failure cardiovascular events.
In Europe, no agent, including rosiglitazone, is currently approved for the treatment of pre-diabetes.
GSK believes data from ongoing and future clinical trials will provide additional scientific support for both the benefit and safety of rosiglitazone. GSK has agreed to work with the FDA to plan and carry out a clinical trial to further investigate the cardiovascular effects of rosiglitazone. Rosiglitazone has been prescribed to more than seven million people in the US over the last seven years to help them control their blood sugar levels. Importantly, rosiglitazone has been shown to control blood sugar for longer than the most commonly used oral anti-diabetic medicines (metformin and SU) – for nearly five years. Long-term glycaemic control is important to help prevent the serious complications of diabetes, especially microvascular complications leading to blindness, amputation and kidney failure. Rosiglitazone is an important treatment option for physicians, since two-thirds of diabetic patients suffer with uncontrolled disease and many require two or three medicines to maintain their blood sugar. GlaxoSmithKline — one of the world’s leading research-based pharmaceutical and healthcare companies — is committed to improving the quality of human life by enabling people to do more, feel better and live longer. Important Information for Avandia (rosiglitazone maleate) in Europe Rosiglitazone helps improve blood sugar control in Type 2 diabetes. It may be taken alone by diabetic patients who cannot take metformin, in combination with metformin or a sulphonylurea, or with both metformin and a sulphonylurea. It is contraindicated for use in combination with insulin. Rosiglitazone is also contraindicated for patients with cardiac failure and may cause fluid retention. Patients with sudden rapid increase in weight, increasing edema or shortness of breath should consult their doctor. An increased risk of bone fracture has been seen in women taking rosiglitazone. The majority of the reported fractures occurred in the hand, foot and arm. Patients with liver impairment should not take rosiglitazone. Blood tests should be used to check for liver problems before starting treatment, and periodically after that according to clinical appropriateness. Caution is advised when using rosiglitazone in patients with significant renal impairment. Rarely, some people have experienced vision changes due to swelling in the back of the eye while taking rosiglitazone When used in combination therapy, particularly with sulphonylurea, hypoglycaemia may occur. Dose reduction of concomitant diabetes therapy may be required. Rosiglitazone may increase the likelihood of pregnancy. Where appropriate, patients should seek contraceptive advice from their doctor prior to commencing therapy. Rosiglitazone is contraindicated while breast feeding. The above information reflects the current SPC for rosiglitazone in Europe. The EMEA have provided additional updates regarding the rosiglitazone label in an 18 Oct press statement that can be accessed via the EMEA website.
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