ADR that result in revision of patient information
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| UK and Singapore: Updates on the voluntary worldwide suspension of the sales of Tredaptive (Extended Release Niacin/Laropiprant) |
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1. UK: Class 2 Drug Alert (Action Within 48 Hours): Merck Sharp & Dohme Ltd recalls Tredaptive modified-release tablets - Nicotinic acid and Laropiprant
All unexpired stock of both originator and parallel-distributed packs of this product are being recalled to pharmacy, clinic and wholesaler level irrespective of batch number, expiry date and pack size. The product is being withdrawn throughout the European Union after a study has shown a failure to reduce major vascular events and an increase in non-fatal serious adverse events. Both the Committee for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance Risk Assessment Committee have concluded that the benefits no longer outweigh the risks. No further Tredaptive tablets should be dispensed. Pharmacists should refer patients with new or repeat prescriptions to the treating physician to review their treatment plan on a non-urgent basis. Any remaining stock of this product should be quarantined, identified as originator or parallel-distributed stock and returned to the original supplier in the normal way.
Please refer to the following website in MHRA for details:http://www.mhra.gov.uk/Publications/Safetywarnings/../CON226929
2. Singapore: HSA updates on the voluntary worldwide suspension of the sales of TredaptiveTM (Extended Release Niacin/Laropiprant) by Merck Sharp & Dohme
Merck Sharp & Dohme (MSD), in consultation with the Health Sciences Authority (HSA), is suspending the sales of TredaptiveTM (extended release niacin/laropiprant) following a preliminary assessment of the findings of the HPS2-THRIVE (Heart Protection Study 2- Treatment of HDL to Reduce the Incidence of Vascular Events) study. HSA has reviewed the data from the study and taken steps to suspend the licence of TredaptiveTM. In the study, the preliminary findings showed that adding the combination of extended-release niacin and laropiprant to statin therapy did not significantly further reduce the risk of major vascular events such as heart attack and stroke compared to statin therapy alone. In addition, there was a statistically significant increase in the incidence of some types of non-fatal serious adverse events (such as muscle weakness, infections and adverse reactions involving the skin and gut) in the group that received extended-release niacin/laropiprant. With this latest update from MSD, HSA is working with MSD to effect the recall of TredaptiveTM. HSA is also working with MSD to communicate this information to healthcare professionals with advice to review the treatment plans for patients taking TredaptiveTM as soon as possible, to discontinue the medication and consider other changes in therapy to achieve their treatment goals for high cholesterol.
Please refer to the following website in HSA for details:http://www.hsa.gov.sg/publish/hsaportal/../hsa_updates_on_the.html
In Hong Kong, Tredaptive (ER Niacin/Laropiprant) 1g/20mg Tab (HK-57317) is registered by Merck Sharp & Dohme (Asia) Ltd. and is a prescription-only medicine. Related news has been released by the EMA and HSA, and was posted on the website of Drug Office on 22 December 2012, 9 January 2013, 11 January 2013 and 19 January 2013. A letter to inform healthcare professionals was issued on 24 December 2012. A total recall of the product was initated on 21 January 2013 and a press release was issued on the same day. As reported on 11 January 2013, the matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Tuesday, January 22, 2013
Issued at HKT 12:30
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