ADR that result in revision of patient information
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| Singapore: Restricted indications and new contraindication for trimetazidine-containing products |
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HSA would like to inform healthcare professionals about new restrictions on the use of trimetazidine-containing products arising from amendments to the uses of Vastarel® and Vastarel MR® initiated by the product licence holder. These amendments are related to recent assessments by the European Medicines Agency (EMA) involving the efficacy and safety of trimetazidine. HSA has approved the amendments to maintain the positive benefit-risk balance of the products. Specifically, trimetazidine-containing products should only be prescribed in adult patients as add-on therapy for the symptomatic treatment of stable angina pectoris inadequately controlled by first-line anti-anginal therapies or to patients intolerant to such therapy. Consequently, trimetazidine is no longer indicated for the symptomatic treatment of vertigo, tinnitus and visual field disturbances. New contraindications for trimetazidine include patients with Parkinson disease, Parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders. The occurrence of such disorders should lead to definitive withdrawal of trimetazidine. Trimetazidine is also contraindicated in patients with severe renal impairment, while patients with moderate renal impairment and the elderly should have their doses reduced. Healthcare professionals are advised to monitor their patients for possible movement disorders such as Parkinsonian symptoms and to discontinue trimetazidine permanently in these patients should such disorders develop.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/publish/hsaportal/../restricted_indications.html
In Hong Kong, there are 7 registered trimetazidine-containing pharmaceutical products registered and are prescription-only medicines. Related news has been released by the EMA and was posted on the website of Drug Office on 25 June 2012. A letter to inform healthcare professionals to draw their attention on the issue and urge them to report any adverse drug reaction related to the drug was issued on the same day. The package inserts of the products are in the process of including the relevant safety information. The Department of Health will keep vigilant on any safety updates of the drug and actions taken by overseas regulatory authorities for consideration of any action deemed necessary.
Ends/ Friday, August 30, 2013
Issued at HKT 12:30 |
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