GSK revises US Avandia label to include new restrictions on use
London, UK & Philadelphia, 7 February 2011 - GlaxoSmithKline (GSK) today announced revised US prescribing information and medication guides for all rosiglitazone-containing medicines (Avandia®, Avandamet® and Avandaryl®) to include additional safety information and restrictions on the use of these medicines. The new label content reflects the US Food and Drug Administration’s review of cardiovascular event data in type 2 diabetes patients treated with Avandia, and follows a meeting of the joint Advisory Committees in July 2010 and a decision in September 2010 by the FDA to restrict access to these medicines.
The revised labels restrict use to patients already taking a rosiglitazone-containing medicine or to new patients who are unable to achieve adequate glycemic control on other diabetes medications and to those, who in consultation with their healthcare provider, have decided not to take Actos (pioglitazone) or other pioglitazone-containing medicines for medical reasons. Patients should consult their healthcare professional for advice on the benefits and risks of Avandia. Other revisions to the label content include changes to the Boxed Warning, Indications and Usage, Dosage and Administration, and Warnings and Precautions. A copy of the updated prescribing information for each rosiglitazone-containing medicine has been made available by the FDA (New US Avandia Label; New US Avandamet label; New US Avandaryl label).
As part of the September decision, the FDA had required GSK to establish a Risk Evaluation and Mitigation Strategy (REMS) programme which will restrict availability of these medicines. GSK is working closely with the FDA to finalise the REMS programme.
The FDA had also required an independent re-adjudication of the endpoints reported in the cardiovascular safety study, RECORD. GSK continues to work to meet the FDA’s request.
GSK is fully committed to patient safety and continues to work with the FDA in the best interest of patients. Patients should be advised to avoid abruptly discontinuing their diabetes medicine without consulting their physician.
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. For further information please visit www.gsk.com
GlaxoSmithKline enquiries UK Media enquiries: David Mawdsley (020) 8047 5502 Claire Brough (020) 8047 5502 Stephen Rea (020) 8047 5502 Alexandra Harrison (020) 8047 5502 David Daley (020) 8047 5502 US Media enquiries: Nancy Pekarek (919) 483 2839 Mary Anne Rhyne (919) 483 2839 Kevin Colgan (919) 483 2839 Jennifer Armstrong (919) 483 2839 European Analyst/Investor enquiries: Sally Ferguson (020) 8047 5543 Gary Davies (020) 8047 5503 Ziba Shamsi (020) 8047 3289 US Analyst/ Investor enquiries: Tom Curry (215) 751 5419
GlaxoSmithKline Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2009.
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Posted: February 2011
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