31st Jul 2007 07:00
GlaxoSmithKline PLC31 July 2007 FDA Advisory Panel Votes 22 to 1 For Avandia(R) to Remain Available to Patients in the US 30 July 2007 - Philadelphia, PA GlaxoSmithKline (NYSE: GSK) today welcomed thenearly unanimous recommendation of an U.S. Food and Drug Administration's (FDA)advisory committee to support Avandia's (rosiglitazone maleate) continuedavailability to patients in the US. The company said it will continue toprovide information to the FDA to assist in the Agency's final decision-making. On July 30th, the FDA Endocrinologic and Metabolic Drugs Advisory Committee andthe Drug Safety and Risk Management Advisory Committee voted that the datasuggests some ischemic risk with Avandia, a treatment for type 2 diabetes. Thecommittee declined to comment on comparative risk of Avandia to other oralanti-diabetic medicines. The committee also voted to keep the medicineavailable to patients in the US. The FDA will review the panel's recommendationbefore making a decision. "We welcome this decision as positive for patients. This was the firstopportunity for these scientific experts to review the full data behind Avandia.The committee recognized the debilitating nature of this disease and theimportance of multiple treatment options," said Dr. Ronald Krall, Chief MedicalOfficer, GlaxoSmithKline. "Diabetes is a progressive disease that exacts aterrible toll on its victims, and it is important that Avandia remain atreatment option for patients." About GlaxoSmithKline GlaxoSmithKline - one of the world's leading research-based pharmaceutical andhealthcare companies - is committed to improving the quality of human life byenabling people to do more, feel better and live longer. For companyinformation, visit GlaxoSmithKline on the World Wide Web at www.gsk.com. S M BicknellCompany Secretary30th July 2007 Important Safety Information for Avandia(R) (rosiglitazone maleate) Avandia, along with diet and exercise, helps improve blood sugar control. It maybe taken alone or with other diabetes medicines. For some people taking Avandia,possible side effects include heart failure or other heart problems. Furtherinformation regarding potential heart-related risks is currently under review bythe FDA. Talk to your doctor as FDA has made information on potentialheart-related risks available to physicians on its website at www.fda.gov. Tellyour doctor if you have heart problems or heart failure. Avandia can cause yourbody to keep extra fluid, which leads to swelling and weight gain. Extra bodyfluid can make some heart problems worse or lead to heart failure. If you haveswelling or fluid retention, shortness of breath or trouble breathing, anunusually rapid increase in weight, or unusual tiredness while taking Avandia,call your doctor right away. You should not take Avandia if you have liverproblems. Blood tests should be used to check for liver problems before startingand while taking Avandia. Tell your doctor if you have liver disease, or if youexperience unexplained tiredness, stomach problems, dark urine or yellowing ofskin while taking Avandia. Tell your doctor about all of the medicines you aretaking. If you are taking Avandia with another diabetes medicine that lowersblood sugar, you may be at increased risk for low blood sugar. Ask your doctorwhether you need to lower the dose of your other diabetes medicine. Avandia mayincrease your risk of pregnancy. Talk to your doctor before taking Avandia ifyou could become pregnant or if you are pregnant. If you are nursing, you shouldnot take Avandia. Talk to your doctor for advice on how to keep your boneshealthy. More fractures, usually in the upper arm, hand, or foot, have been seenin women taking Avandia. Your doctor should check your eyes regularly. Veryrarely, some people have experienced vision changes due to swelling in the backof the eye while taking Avandia. US Media inquiries: Nancy Pekarek (215) 751 7709 Mary Anne Rhyne (919) 483 2839 Alice Hunt (215) 751 7709 UK Media inquiries: Phil Thomson (020) 8047 5502 Joss Mathieson (020) 8047 5502 Claire Brough (020) 8047 5502 US Analyst/ Investor inquiries: Frank Murdolo (215) 751 7002 Tom Curry (215) 751 5419 European Analyst/Investor inquiries: David Mawdsley (020) 8047 5564 Sally Ferguson (020) 8047 5543 This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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