ADR that result in revision of patient information
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| Australia: Safety advisory: Galantamine - serious skin reactions |
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Consumers and health professionals are advised that Janssen-Cilag, in consultation with the TGA, has updated the Product Information (PI) for galantamine (marketed under the brand name Reminyl, as well as a number of generic brands). Galantamine is used to treat mild to moderately severe dementia of the Alzheimer type. The PI update has added a new precaution for serious skin reactions, including Stevens-Johnson syndrome and acute generalised exanthematous pustulosis. Such reactions have been reported in patients receiving galantamine. Stevens-Johnson syndrome and acute generalised exanthematous pustulosis have also been added to the adverse effects section of the PI as very rare adverse events associated with galantamine treatment.
Healthcare professionals are advised to educate patients and their carers about the signs of serious skin reactions, including Stevens-Johnson syndrome and acute generalised exanthematous pustulosis Patients and carers should also be instructed to discontinue treatment with galantamine at the first sign of skin rash or ulcers and other lesions in the mucous membranes, and then seek medical attention.
Please refer to the following website in TGA for details:
http://tga.gov.au/alert/galantamine
In Hong Kong, there are five registered pharmaceutical products containing galantamine, namely Reminyl Oral Solution 4mg/ml (HK-49407), Reminyl Prolonged Release Cap 24mg (HK-55292), Reminyl Prolonged Release Cap 8mg (HK-55293), Reminyl Prolonged Release Cap 16mg (HK-55294), HC Galanthamine Hydrobromide Dispersible Tablets 4mg (HK-62303). All of the products are prescription-only medicines. Related news has been released by Singapore HSA and Health Canada, and was posted on the Drug Office website on 7 August and 19 November 2014 respectively. So far, the Department of Health (DH) has not received any local adverse drugs reaction reports on serious skin reactions related to the drug. Letter to healthcare professionals to draw their attention to the matter and urge them to report any adverse drug reaction related to the drug was issued on 7 August 2014. The matter has been discussed in the meeting of the Registration Committee (the Committee) of the Pharmacy and Poisons Board on 3 December 2014. The Committee decided that the product inserts of products containing galantamine should be updated to include the new safety warnings. The DH will remain vigilant on any safety updates of the drug.
Ends/ Monday, December 08, 2014
Issued at HKT 15:00
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