European Medicine Agency (EMEA) Confirms Positive Avandia Benefit Risk Assessment

Main Category: Diabetes
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 21 Oct 2007 - 0:00 PDT

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GlaxoSmithKline confirms that the EMEA's Committee for Medicinal Products for Human Use(CHMP) has completed its benefit risk review of the Thiazolidinediones (TZD) class and have concluded that the benefits of rosiglitazone continue to outweigh the risks.

"The EMEA has completed its review and recognises the positive benefit risk of rosiglitazone in Europe and its importance in the treatment of patients with type 2 diabetes," said Dr Alastair Benbow, Vice President and European Medical Director, GSK. "GSK is confident in the safety profile of rosiglitazone when used appropriately by physicians."

GSK will continue to work with the agency on appropriate wording for the SPC in order to help physicians provide the best treatment guidance to patients.

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.

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.

GlaxoSmithKline
http://www.gsk.com

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