Other safety alerts
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| The United States: Pioglitazone-containing medicines: Drug Safety Communication - updated FDA review, increased risk of bladder cancer |
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The U.S Food and Drug Administration (FDA) announced that as a result of an updated review, the FDA has concluded that use of the type 2 diabetes medicine pioglitazone (Actos, Actoplus Met, Actoplus Met XR, Duetact, Oseni) may be linked to an increased risk of bladder cancer. The labels of pioglitazone-containing medicines already contain warnings about this risk, and FDA has approved label updates to describe the additional studies reviewed. Details including a data summary can be found at the FDA website.
FDA alerted the public about the possible risk of bladder cancer in September 2010 and June 2011 based on interim results from a 10-year epidemiologic study. FDA changed the labels of pioglitazone-containing medicines in August 2011 to include warnings about this risk, and required the manufacturer to modify and continue the 10-year study.
Pioglitazone is approved to improve blood sugar control, along with diet and exercise, in adults with type 2 diabetes. Pioglitazone works by increasing the body’s sensitivity to insulin, a natural hormone that helps control blood sugar levels. Untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease.
Health care professionals should not use pioglitazone in patients with active bladder cancer, and should carefully consider the benefits and risks before using pioglitazone in patients with a history of bladder cancer.
Patients should contact their health care professionals if they experience any of the following signs or symptoms after starting pioglitazone, as these may be due to bladder cancer:
• Blood or a red color in the urine
• New or worsening urge to urinate
• Pain when urinating
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm532772.htm
In Hong Kong, there are 29 registered pharmaceutical products containing pioglitazone, and are prescription only medicines. Related news on risk of bladder cancer was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since September 2010, with the last update posted on 4 May 2012. Letters to inform local healthcare professionals were issued on 16 June 2011 and 22 July 2011. So far, the Department of Health (DH) has not received any adverse drug reaction report related to pioglitazone. In September 2011, the matter was discussed by the Registration Committee of the Pharmacy and Poisons Board. The Committee decided that the package insert of pioglitazone-containing products should be updated to include the appropriate safety information. DH will continue to remain vigilant on the safety update on pioglitazone-containing medicines.
Ends/ Tuesday, December 13, 2016
Issued at HKT 13:00
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