Other safety alerts
|
| |
| The United States: Saxagliptin (marketed as Onglyza and Kombiglyze XR): Drug Safety Communication - FDA to Review Heart Failure Risk |
| |
The US Food and Drug Administration (FDA) has requested clinical trial data from the manufacturer of saxagliptin to investigate a possible association between use of the type 2 diabetes drug and heart failure. FDA’s request resulted from a study published in the New England Journal of Medicine (NEJM), which reported an increased rate of hospitalization for heart failure, when the heart does not pump blood well enough, with use of saxagliptin compared to an inactive treatment. The study did not find increased rates of death or other major cardiovascular risks, including heart attack or stroke, in patients who received saxagliptin. The manufacturer is expected to submit the trial data to FDA by early March 2014, after which FDA will conduct a thorough analysis and report findings publicly.
At this time, FDA considers information from the NEJM study to be preliminary. Analysis of the saxagliptin clinical trial data is part of a broader evaluation of all type 2 diabetes drug therapies and cardiovascular risk.
Saxagliptin is used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. It works by increasing the amount of insulin produced by the body after meals, when blood sugar is high.
Patients should not stop taking saxagliptin and should speak with their healthcare professionals about any questions or concerns. Healthcare professionals should continue to follow the prescribing recommendations in the drug labels.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm385471.htm
In Hong Kong, there are five registered pharmaceutical products containing saxagliptin. They are all prescription only medicines and registered by Bristol-Myers Squibb Pharma (HK) Ltd. The Department of Health (DH) has not received any adverse reaction report in connection with the drug. In view of FDA’s announcement, a letter to inform healthcare professionals will be issued. DH has contacted the company for requesting the trial data and the matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board. DH will keep vigilant on any safety updates of the drug and actions taken by overseas regulatory authorities.
Ends/ Wednesday, February 12, 2014
Issued at HKT 13:00
|
| |
|
