ADR that result in revision of patient information
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| Singapore: Communication on the risk of severe skin reactions with Dilatrend (carvedilol) |
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Roche is informing healthcare professionals of newly emerged safety information for Dilatrend. From a review of the cumulative data from the company's safety database, very rare cases of severe cutaneous adverse reactions such as toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS) have been reported during treatment with carvedilol. The package insert for Dilatrend will be updated with this important new safety information. Healthcare professionals are recommended to consider permanently discontinuing the use of Dilatrend in patients who experience severe cutaneous adverse reactions possibly attributable to carvedilol.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/publish/hsaportal/../DHCPL.html
In Hong Kong, there are a total of 27 carvedilol containing pharmaceutical products including Dilatrend Tab 25mg (HK-36984), Dilatrend Tab 12.5mg (HK-42821) and Dilatrend Tab 6.25mg (HK-42822) which are registered by Roche Hong Kong Limited (Roche). All of them are prescription only medicines. According to Roche, a letter to healthcare professionals has been issued on 1 April 2014 to draw their attention to the issue, and will submit an application to the Department of Health (DH) to update the package insert of the products to include the relevant warnings and precautions. So far, the DH has not received any adverse reaction report in connection with the drug. In view of HSA's announcement, a Dear Healthcare Professional Letter will be issued and the matter will be brought up to the Product Registration Committee of the Pharmacy and Poisons Board for consideration.
Ends/ Thursday, April 10, 2014
Issued at HKT 14:00
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