ADR that result in revision of patient information
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| The United States: Canagliflozin (Invokana, Invokamet) and Dapagliflozin (Farxiga, Xigduo XR): Drug Safety Communication - Strengthened kidney warnings |
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The U.S. Food and Drug Administration (FDA) has strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR). Based on recent reports, FDA has revised the warnings in the drug labels to include information about acute kidney injury and added recommendations to minimize this risk.
Canagliflozin and dapagliflozin are prescription medicines used with diet and exercise to help lower blood sugar in adults with type 2 diabetes. They belong to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Canagliflozin and dapagliflozin lower blood sugar by causing the kidneys to remove sugar from the body through the urine.
From March 2013, when canagliflozin was approved in the U.S., to October 2015, FDA received reports of 101 confirmable cases of acute kidney injury, some requiring hospitalization and dialysis, with canagliflozin or dapagliflozin use. This number includes only reports submitted to FDA, so there are likely additional cases about which FDA is unaware.
FDA advised health care professionals to consider factors that may predispose patients to acute kidney injury prior to starting them on canagliflozin or dapagliflozin. These include decreased blood volume; chronic kidney insufficiency; congestive heart failure; and taking other medications such as diuretics, blood pressure medicines called angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs), and nonsteroidal anti-inflammatory drugs (NSAIDs). Assess kidney function prior to starting canagliflozin or dapagliflozin and monitor periodically thereafter. If acute kidney injury occurs, promptly discontinue the drug and treat the kidney impairment.
Patients should seek medical attention immediately if they experience signs and symptoms of acute kidney injury. This is a serious condition in which the kidneys suddenly stop working, causing dangerous levels of wastes to build up in the body. Signs and symptoms of acute kidney injury may include decreased urine or swelling in the legs or feet. Patients should not stop taking their medicine without first talking to their health care professionals. Doing so can lead to uncontrolled blood sugar levels that can be harmful.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm506554.htm
In Hong Kong, there are two pharmaceutical products containing canagliflozin, namely Invokana Tablets 100mg (HK-63499) and 300mg (HK-63500) which are registered by Johnson & Johnson (HK) Ltd; and two pharmaceutical products containing dapagliflozin, namely Forxiga Tablets 5mg (HK-63301) and 10mg (HK-63302) which are registered by AstraZeneca Hong Kong Ltd. All products are prescription only medicines. So far, the Department of Health has received one adverse drug reaction case in connection with canagliflozin and another case in connection with dapagliflozin, but both were not related to acute kidney injury. In view of the above FDA announcement, letters to local healthcare professionals to draw their attention to the warnings will be issued, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Wednesday, June 15, 2016
Issued at HKT 14:00
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