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    EMA Extends Amputation Investigation to All SGLT2 Inhibitors


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    EMA Extends Amputation Investigation to All SGLT2 Inhibitors

    Post by graham64 on Sat Jul 09 2016, 23:48

    The European Medicines Agency (EMA)'s Pharmacovigilance Risk Assessment Committee (PRAC) has extended the scope of its investigation into the possible link between the sodium glucose cotransporter 2 (SGLT2) inhibitor canagliflozin (Invokana, Vokanamet, Janssen) and amputations to include other drugs of the same class.

    Now, the PRAC's review will include the other SGLT2 inhibitor medicines dapagliflozin (Farxiga, Xigduo XR, AstraZeneca), and empagliflozin (Jardiance, Boehringer Ingelheim), based on the determination that the potential risk may be relevant for them as well.

    In April 2016, PRAC launched a safety review of canagliflozin based on an increase in amputations — mostly of the toes — seen in the ongoing long-term Canagliflozin Cardiovascular Assessment Study (CANVAS).

    A 4.5-year interim analysis by the independent monitoring committee for the trial found that the rate of amputations per every 1000 patients was equivalent to seven for 100 mg/day and five for 300 mg/day of canagliflozin compared with three per 1000 patients taking placebo.

    No such increase in amputations was seen in 12 other completed clinical trials with canagliflozin, although a small, statistically nonsignificant increase in the number of amputations occurred in another ongoing study called CANVAS-R. Both CANVAS and CANVAS-R involve patients at high cardiovascular risk.

    Based on all the data, the monitoring committee recommended that CANVAS continue through its scheduled 2017 completion.

    In its April move, PRAC had requested more information from the company to assess whether canagliflozin causes an increase in lower-limb amputations and whether any changes are needed in the way the drug is used in the European Union.

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