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Invokana Adds Warnings On Amputation Risk, But Will It Give Jardiance An Edge?

 
• By Brenda Sandburg

New data from J&J's cardiovascular outcomes trials shows leg and foot amputations occurred about twice as often in diabetes patients treated with canagliflozin versus placebo.

FDA is requiring a boxed warning on Johnson & Johnson's Invokana (canagliflozin), Invokamet (canagliflozin/metformin) and Invokamet XR labeling about the increased risk of leg and foot amputations in patients taking the diabetes medicines.

The agency issued a safety announcement May 16 confirming the risk based on new data from J&J's two cardiovascular outcomes trials, which showed leg and foot amputations occurred about twice as often in patients treated with the SGLT-2 inhibitor canagliflozin compared to those treated with placebo

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The European Medicines Agency is investigating whether Valneva’s Ixchiq is safe to use in the elderly, following reports of 17 serious adverse events, including two cases resulting in death, in people aged 62 to 89 years who received the vaccine. This follows actions by US and French authorities last month regarding Ixchiq’s use in people over 65.

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UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 
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EU Health Data Space May Speed Up R&D Through Access To Multi-Omics & Clinical Record Data

 
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