Medicine recalls
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| The United States: Ondansetron (Zofran) 32 mg, Single Intravenous (IV) Dose: Updated Safety Communication – Product Removal due to Potential For Serious Cardiac Risks |
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The US Food and Drug Administration (FDA) is notifying healthcare professionals that the 32 mg, single intravenous (IV) dose of the anti-nausea drug Zofran (ondansetron hydrochloride) will no longer be marketed because of the potential for serious cardiac risks. This dose has been removed from the Zofran drug label. FDA is now working with the manufacturers of all 32 mg dose ondansetron injectable products (brand and generic) to voluntarily recall them from the market. These drugs are sold pre-mixed in solutions of either dextrose or sodium chloride in plastic containers.
The 32 mg, single IV dose had been used to prevent chemotherapy-induced nausea and vomiting. A previous FDA’s Drug Safety Communication, issued on June 29, 2012, communicated that the 32 mg, single IV dose should be avoided due to the risk of a specific type of irregular heart rhythm called QT interval prolongation, which can lead to Torsades de Pointes, an abnormal, potentially fatal heart rhythm.
FDA anticipates these products to be removed from the market through early 2013. FDA does not anticipate that removal of the 32 mg intravenous dose of ondansetron currently sold as pre-mixed injections will contribute to a drug shortage of IV ondansetron, as the 32 mg dose makes up a very small percentage of the current market.
FDA continues to recommend the intravenous regimen of 0.15 mg/kg administered every 4 hours for three doses to prevent chemotherapy-induced nausea and vomiting. If the calculated weight-based dose were to exceed 16 mg, the potential for prolonged QT interval would be greater; therefore, no single intravenous dose should exceed 16 mg. In addition, oral dosing of ondansetron remains effective for the prevention of chemotherapy-induced nausea and vomiting. At this time, there is not enough information available for FDA to recommend an alternative single IV dose regimen.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm330772.htm
In Hong Kong, there are 24 registered pharmaceutical products containing ondansetron and are prescription-only medicines. Seven of them are injectable products and none of the injectable products have approved strength being 32mg. Related news has been released by the US FDA, UK MHRA and Health Canada, and was posted on the website of Drug Office on 16 September 2011, 30 June 2012, 3 August 2012 and 10 October 2012. Letters to inform healthcare professionals were issued on 16 September 2011 and 3 July 2012. The issue was preliminary discussed by the Registration Committee (the Committee) of the Pharmacy and Poisons Board on 28 February 2012 and the Committee decided that the drug product label should include safety information on risk of QT prolongation and Torsades de Pointes associated with the drug, while the matter related to dosage will be further discussed in the meeting of the Committee.
Ends/ Wednesday, December 05, 2012
Issued at HKT 14:00
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http://download.cnet.com/YouTube-To-MP3/3000-2071_4-75810474.html >there |
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