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    FDA warns of foot, leg amputations with Invokana (canagliflozin)

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    graham64
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    FDA warns of foot, leg amputations with Invokana (canagliflozin)

    Post by graham64 on Wed May 17 2017, 21:37

    Johnson & Johnson (JNJ.N) is required to add new warnings to its diabetes drug, Invokana, about the risk of foot and leg amputations, the U.S. Food and Drug Administration said on Tuesday.

    Final results from two clinical trials showed leg and foot amputations occurred about twice as often in patients with type 2 diabetes treated with Invokana, known also as canagliflozin, as those given a placebo, the FDA said in an announcement posted on its website.

    The warnings include a boxed warning, reserved for the most serious possible adverse events, the FDA said.

    Invokana belongs to a relatively new class of type 2 diabetes drugs called SGLT-2 inhibitors, which help remove excess blood sugar through urine. Others in the class include Eli Lilly and Co's (LLY.N) Jardiance and AstraZeneca Plc's (AZN.L) Farxiga.

    The FDA noted that results of one clinical trial showed that over the course of a year the risk of amputation in patients treated with Invokana was equivalent to 5.9 out of 1,000, compared with 2.8 out of 1,000 for patients given a placebo.

    A second trial showed the risk of amputation was equivalent to 7.5 out of every 1,000 patients treated with Invokana compared with 4.2 out of every 1,000 patients given a placebo.

    The agency said amputations of the toe and middle of the foot were the most common but that amputations involving the leg, below and above the knee, also occurred.

    Untreated type 2 diabetes can cause blindness, nerve and kidney damage and heart disease.

    http://uk.reuters.com/article/us-health-diabetes-johnson-johnson-idUKKCN18C2RC?rpc=401&


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    chris c
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    Re: FDA warns of foot, leg amputations with Invokana (canagliflozin)

    Post by chris c on Thu May 18 2017, 23:23

    That's OK, you have another one! said a company spokesman from his overseas tax haven
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    Re: FDA warns of foot, leg amputations with Invokana (canagliflozin)

    Post by graham64 on Fri May 19 2017, 22:18

    There is some good news about SGLT2's they could be protective for those with CKD   

        https://cardiab.biomedcentral.com/articles/10.1186/s12933-017-0547-1

    So at least if your lower limbs are being amputated you can be happy in the knowledge your kidneys will be ok  Cool


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    Re: FDA warns of foot, leg amputations with Invokana (canagliflozin)

    Post by chris c on Sat May 20 2017, 22:13

    Phew, that's a relief! I'll ask my doctor to prescribe some stat.

    Oh hang on though, weren't they also associated with urinary tract infections?
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    Re: FDA warns of foot, leg amputations with Invokana (canagliflozin)

    Post by chris c on Wed May 24 2017, 22:57

    In a muffled voice from inside Rory Collins pocket, Peter Sever said

    "These patients were delusional to believe they ever had two feet in the first place. Clearly they need stronger psychiatric medication"

    Rory Collins added

    "We have evidence that statins will regrow missing limbs. Of course we aren't going to show you this data, you just have to trust me!"

      Current date/time is Fri Nov 17 2017, 21:07