ADR that result in revision of patient information
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| The United States: Invokana and Invokamet (canagliflozin): Drug Safety Communication - New information on bone fracture risk and decreased bone mineral density |
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FDA has strengthened the warning for the type 2 diabetes medicine canagliflozin (Invokana, Invokamet) related to the increased risk of bone fractures, and added new information about decreased bone mineral density. To address these safety concerns, FDA added a new WARNING AND PRECAUTION and revised the ADVERSE REACTIONS section of the Invokana and Invokamet drug labels.
FDA is continuing to evaluate the risk of bone fractures with other drugs in the SGLT2 inhibitor class, including dapagliflozin (Farxiga, Xigduo XR) and empagliflozin (Jardiance, Glyxambi, Synjardy), to determine if additional label changes or studies are needed.
Canagliflozin is a prescription medicine in the US, and is used with diet and exercise to lower blood sugar in adults with type 2 diabetes. It belongs to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Canagliflozin is available as a single-ingredient product under the brand name Invokana and also in combination with the diabetes medicine metformin under the brand name Invokamet. Bone mineral density relates to the strength of a person’s bones.
Health Care Professionals are advised of the following:
• Bone fractures have been seen in patients taking the type 2 diabetes medicine canagliflozin.
• Fractures can occur as early as 12 weeks after starting canagliflozin.
• Canagliflozin has also been linked to decreases in bone mineral density at the hip and lower spine.
• Consider factors that contribute to fracture risk prior to initiating canagliflozin.
• Counsel patients about factors that may contribute to bone fracture risk.
Patients are advised of the following:
• Talk to their health care professionals about factors that may increase their risk for bone fracture.
• Do not stop or change their diabetes medicines without first talking to their health care professional. When untreated, diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm461876.htm
In Hong Kong, there are two registered pharmaceutical products containing canagliflozin, namely Invokana Tablets 100mg (HK-63499) and Invokana Tablets 300mg (HK-63500) which are registered by Johnson & Johnson (Hong Kong) Ltd, and two registered pharmaceutical products containing dapagliflozin, namely Forxiga Tablet 5mg (HK-63301) and Forxiga Tablet 10mg (HK-63302) which are registered by Astrazeneca Hong Kong Ltd. All products are prescription-only medicines. There is no registered pharmaceutical product containing empagliflozin. So far, the Department of Health (DH) has not received any adverse drug reaction (ADR) case on Invokana. DH has received one ADR case on Forxiga, and it is not related to bone fracture and/ or decreased bone mineral density. In view of the US FDA's announcement on strengthened warning for canagliflozin-containing medicines, letters to local healthcare professionals will be issued to draw their attention to the warning, and the matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Friday, September 11, 2015
Issued at HKT 13:00
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