其 他 安 全 警 示
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| The United States: FDA removes Boxed Warning about risk of leg and foot amputations for the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) (English only) |
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The US Food and Drug Administration (FDA) announces an update to its previously issued FDA Drug Safety Communication regarding canagliflozin in May 2017.
Based on a FDA review of new data from three clinical trials, FDA has removed the Boxed Warning about amputation risk from the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) prescribing information.
FDA required the Boxed Warning in 2017 based on its assessment that the risk of amputations was very serious in relation to the potential benefit of canagliflozin, which was initially approved to be used with diet and exercise to lower blood sugar in adults with type 2 diabetes. Subsequent FDA reviews of new clinical trial data demonstrated additional heart- and kidney-related benefits, which led to additional approved uses. Specifically, in 2018, canagliflozin was approved to reduce the risk of major heart-related events such as heart attack, stroke, or death in patients with type 2 diabetes who have known heart disease; and, in 2019, it was approved to reduce the risk of end-stage kidney disease, worsening of kidney function, heart-related death, and being hospitalized for heart failure in certain patients with type 2 diabetes and diabetic kidney disease.
Collectively, these newly identified effects of canagliflozin on heart and kidney disease show significantly enhanced benefit of this medicine. Safety information from recent clinical trials also suggests that the risk of amputation, while still increased with canagliflozin, is lower than previously described, particularly when appropriately monitored. Based upon these considerations, FDA has concluded that the Boxed Warning should be removed. The amputation risk with canagliflozin remains and is still described in the Warnings and Precautions section of the prescribing information.
Health care professionals and patients should continue to recognize the importance of preventative foot care and monitor for new pain, tenderness, sores, ulcers, and infections in the legs and feet. Risk factors that may predispose patients to the need for amputation should be considered when choosing antidiabetic medicines.
Please refer to the following website in FDA for details:
http://www.fda.gov/drugs/drug-safety-and-availability/fda-removes-boxed-warning-about-risk-leg-and-foot-amputations-diabetes-medicine-canagliflozin
In Hong Kong, there are 4 registered pharmaceutical products containing canagliflozin, namely Invokana Tablets 100mg (HK-63499), Invokana Tablets 300mg (HK-63500), Invokana Tablets 100mg (HK-66454) and Invokana Tablets 300mg (HK-66455). All products are registered by Johnson & Johnson (Hong Kong) Ltd, and are prescription-only medicines. So far, the Department of Health (DH) has received 2 cases of adverse drug reaction related to canagliflozin, but these cases were not related to lower limb amputation.
Related news was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 18 Apr 2016, with the latest update posted on 18 May 2018. Letters to inform local healthcare professionals were issued by the DH on 18 Apr 2016.
In Sep 2017, the Registration Committee of the Pharmacy and Poisons Board discussed the matter, and decided that the package insert should include safety information on the risk of lower limb amputation. The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Thursday, Aug 27, 2020
Issued at HKT 18:00
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