ADR that result in revision of patient information
|
| |
| The United States: FDA Drug Safety Communication: FDA adds warnings about heart failure risk to labels of type 2 diabetes medicines containing saxagliptin and alogliptin |
| |
A U.S. Food and Drug Administration (FDA) safety review has found that type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure, particularly in patients who already have heart or kidney disease. This is an update to the FDA Drug Safety Communication: FDA to review heart failure risk with diabetes drug saxagliptin (marketed as Onglyza and Kombiglyze XR) issued on February 11, 2014. Heart failure can result in the heart not being able to pump enough blood to meet the body’s needs. As a result, FDA is adding new Warnings and Precautions to the drug labels about this safety issue.
Saxagliptin and alogliptin are part of the class of dipeptidyl peptidase-4 (DPP-4) inhibitor drugs, which are used with diet and exercise to lower blood sugar in adults with type 2 diabetes. Untreated, type 2 diabetes can lead to serious health problems, including blindness, nerve and kidney damage, and heart disease. Saxagliptin is marketed as Onglyza and Kombiglyze XR, while alogliptin is marketed as Nesina, Kazano and Oseni in the U.S.
FDA evaluated two large clinical trials conducted in patients with heart disease. These clinical trials were also discussed at the FDA Endocrinologic and Metabolic Drugs Advisory Committee meeting in April 2015. Each trial showed that more patients who received saxagliptin- or alogliptin-containing medicines were hospitalized for heart failure compared to patients who received an inactive treatment called a placebo. Details of the results can be found at the FDA website.
Patients are advised to contact their health care professional right away if they develop signs and symptoms of heart failure when taking saxagliptin or alogliptin, such as:
• Unusual shortness of breath during daily activities
• Trouble breathing when lying down
• Tiredness, weakness, or fatigue
• Weight gain with swelling in the ankles, feet, legs, or stomach
Health care professionals are advised of the following:
• Risk factors of hospitalization for heart failure include a history of heart failure or renal impairment, and this safety risk was found in clinical trials among patients with these medical issues.
• Consider the risk and benefits of saxagliptin or alogliptin prior to initiating treatment in patients at a higher risk for heart failure.
• Observe patients receiving saxagliptin or alogliptin for signs and symptoms of heart failure.
• Consider discontinuing the drug and monitor diabetes control if heart failure develops. If blood sugar level is not well-controlled with a patient’s current treatment, other diabetes medicines may be required.
• Encourage patients to read the Medication Guide they receive with their prescriptions.
Please refer to the following website in FDA for details:
http://www.fda.gov/Drugs/DrugSafety/ucm486096.htm
In Hong Kong, there are five registered pharmaceutical products containing saxagliptin approved under the brand names of Onglyza and Kombiglyze XR, and seven registered products containing alogliptin approved under the brand names of Oseni and Nesina. All these products are prescription only medicines. Related news on review of heart failure of saxagliptin was previously issued by the FDA, and was posted on the Drug Office website on 12 February 2014. Letters to inform local healthcare professionals were also issued on the same day. So far, the Department of Health has not received any adverse drug reaction case related to saxagliptin or alogliptin. In view of the conclusion of the FDA safety review, letters to inform local healthcare professionals of the update will be issued, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Wednesday, April 06, 2016
Issued at HKT 15:00
|
| |
|
