ADR that result in revision of patient information
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| The United States: Canagliflozin (Invokana, Invokamet): Drug Safety Communication - Increased Risk of Leg and Foot Amputations |
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The US Food and Drug Administration (FDA), based on new data from two large clinical trials, has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. FDA is requiring new warnings, including the most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk. This information is an update to the FDA safety alert on 18 May 2016. Canagliflozin is a prescription medicine used with diet and exercise to lower blood sugar in adults with type 2 diabetes.
Final results from two clinical trials – the CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus) – showed that leg and foot amputations occurred about twice as often in patients treated with canagliflozin compared to patients treated with placebo, which is an inactive treatment. Amputations of the toe and middle of the foot were the most common. However, amputations involving the leg, below and above the knee, also occurred. Some patients had more than one amputation, some involving both limbs.
Patients taking canagliflozin should notify their health care professionals right away if they develop new pain or tenderness, sores or ulcers, or infections in their legs or feet. Health care professionals should, before starting canagliflozin, consider factors that may predispose patients to the need for amputations and monitor patients receiving canagliflozin for the signs and symptoms described above and discontinue canagliflozin if these complications occur.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm558605.htm
In Hong Kong, there are two registered pharmaceutical products containing canagliflozin, namely Invokana Tablets 100mg (HK-63499) and 300mg (HK-63500) which are registered by Johnson & Johnson (HK) Ltd, and are prescription only medicines. Related news was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 18 April 2016, with the latest update posted on 23 March 2017. Letters to inform local healthcare professionals on the warnings had been issued on 18 April 2016. According to Johnson & Johnson (HK) Ltd, the 2 clinical trials CANVAS and CANVAS-R were not conducted in Hong Kong. So far, the Department of Health (DH) has received two cases of adverse drug reaction in connection with canagliflozin, but none of them were related to amputation. As previously reported, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board. The information including update label requirement of canagliflozin in the above FDA announcement together with the other previously issued safety alerts will also be forwarded to the Registration Committee for consideration.
Ends/Wednesday, May 17, 2017
Issued at HKT 15:00
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