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Home Industry News GSK updates Avandia prescribing information

GSK updates Avandia prescribing information

15th August 2007

GlaxoSmithKline (GSK) has announced that it has received approval from the regulators to update its prescribing information for Avandia (rosiglitazone maleate) – a compound used to treat type two diabetes.

As previously noted, the label for the medication will include a boxed warning to increase the visibility of an existing caution relating to the risk of congestive heart failure for the thiazolidinediones (TZD) class of medicines.

This announcement follows a decision by the US Food and Drug Administration (FDA) to approve the updating of prescribing information for TZDs, while the warning will also note that these drugs are not recommended for patients with symptomatic heart failure.

“Information about [congestive heart failure] has been included in the prescribing information for Avandia since 1999, when the medicine was first approved by the [FDA],” GSK reports.

It adds that in the US, prescribing information for the drug has included a warning relating to cardiac failure and other cardiac effects since 2001, with it recommended that patients discontinue treatment with Avandia if their cardiac status worsens.

Last month, GSK welcomed a 22-to-one recommendation by the advisory committee of the FDA to support the continued availability of Avandia to patients in the US, while the firm reported its commitment to assisting the administration in making its final decision.

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