FDA warns of foot and leg amputations with J & J diabetes drug
| Reuters
Johnson & Johnson ( JNJ.N ) is required to add new warnings to his diabetes medication, Invokana, about the use of this medication in the treatment of diabetes.<span class = "articleLocatio And the leg amputations, the US Food and Drug Administration said on Tuesday
The final results of two clinical trials have shown that amputations of the Legs and feet occurred about twice as often in type 2 patients Diabetes treated with Invokana, also known as canagliflozine, as those who received a placebo, said the FDA in an ad published on its website.
Warnings include a boxed warning, reserved for the most serious possible events, said the FDA.
Invokana belongs to a relatively new class of type 2 diabetes medicines called SGLT-2 inhibitors, which eliminate excess blood sugar in the urine. Other in the class include Eli Lilly and Co ( LLY.N ) Jardiance and AstraZeneca Plc ( AZN.L ) Farxiga.
The FDA noted that the results of a clinical trial showed that within one year the risk of amputation in Invokana treated patients was equivalent To 5.9 out of 1000, compared with 2.8 per 1,000 for patients with placebo.
A second trial showed that the risk of amputation was equivalent to 7.5 of 1000 patients treated with Invokana compared to 4.2 of 1,000 patients receiving placebo.
The agency said that amputations of the toe and middle of the foot were the most common but that amputations involving the leg, below and above the knee, Have also occurred.
Untreated type 2 Diabetes can cause blindness, nerve and kidney damage and heart disease.
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