European recalls of counterfeit schizophrenia drug

European recalls of counterfeit schizophrenia drug Reactions 1664, p1 - 12 Aug 2017 European recalls of counterfeit schizophrenia drug The Danish Medicines Agency (DKMA) and European parallel importers are recalling counterfeit batches of the 1,2 schizophrenia medicine, paliperidone (Xeplion). The first set of recalls was announced late last month by the DKMA, involving one German and several Danish parallel importers that withdrew several batches of Xeplion 150mg injections from wholesale distributors, hospitals and pharmacies. The case originally started in Germany when the parallel importer Haemato Pharm discovered counterfeit packs in one batch of Xeplion 150mg. At least three batches of the product were found to contain both authentic packs and an unknown number of counterfeit packs. Haemato Pharm and a number of Danish parallel importers have restocked packs from the affected batches, and several parallel importers have confirmed they have counterfeit packs in stock. Manufacturer’s findings Janssen (i.e. the manufacturer of Xeplion 150mg) examined one of the counterfeit packs from the two initial batches affected, which were manufactured for sale in Bulgaria and Romania. The company found a number of ways that the counterfeit packs differed from authentic packs, including: (i) different shade of blue on the pack; (ii) outer packaging appeared older; and (iii) inner packaging was of a more recent date and contained needles with a different expiry date. The company also analysed the contents of a prefilled syringe in a counterfeit pack, revealing that "the syringe contained the correct active substance in the appropriate quantities". However, the agency highlighted that it could not be ruled out that the packs had been stored improperly given they were packed outside the legal chain – thereby making them counterfeit medicines. The market withdrawal of a fourth set of counterfeit batches of Xeplion 150mg injections was announced at the beginning of August. Janssen has analysed a total of seven counterfeit packs from the second batch and found that while the outer packaging had been falsified, the syringe, its contents and the enclosed needles were all authentic products. Overall, the DKMA considered that the risk that patients had been injected from a counterfeit pack was low. Batches that have an identified risk of falsification will remain under quarantine at the parallel importers and withdrawn from the market, and will not be released until their authenticity can be established. As per the DKMA’s request, information will be sent to psychiatrists and general practitioners about how to check for counterfeit Xeplion 150mg packs, as well as providing information about possible alternative products. * Other strengths of Xeplion are available, and another product with the same active substance is also available on the market. 1. Danish Medicines Agency. Counterfeit packs of the schizophrenia medicine Xeplion 150 mg. Internet Document : 25 Jul 2017. Available from: URL: https:// laegemiddelstyrelsen.dk/en/news/2017/counterfeit-packs-of-the-schizophrenia- medicine-xeplion-150-mg/. 2. Danish Medicines Agency. Withdrawal of one more batch of counterfeit packs of the schizophrenia medicine Xeplion 150 mg. Internet Document : 1 Aug 2017. Available from: URL: https://laegemiddelstyrelsen.dk/en/news/2017/ withdrawal-of-one-more-batch-of-counterfeit-packs-of-the-schizophrenia- medicine-xeplion-150-mg/. 0114-9954/17/1664-0001/$14.95 Adis © 2017 Springer International Publishing AG. All rights reserved Reactions 12 Aug 2017 No. 1664 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Reactions Weekly Springer Journals

European recalls of counterfeit schizophrenia drug

Reactions Weekly , Volume 1664 (1) – Aug 12, 2017
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Publisher
Springer International Publishing
Copyright
Copyright © 2017 by Springer International Publishing AG
Subject
Medicine & Public Health; Drug Safety and Pharmacovigilance; Pharmacology/Toxicology
ISSN
0114-9954
eISSN
1179-2051
D.O.I.
10.1007/s40278-017-34281-1
Publisher site
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Abstract

Reactions 1664, p1 - 12 Aug 2017 European recalls of counterfeit schizophrenia drug The Danish Medicines Agency (DKMA) and European parallel importers are recalling counterfeit batches of the 1,2 schizophrenia medicine, paliperidone (Xeplion). The first set of recalls was announced late last month by the DKMA, involving one German and several Danish parallel importers that withdrew several batches of Xeplion 150mg injections from wholesale distributors, hospitals and pharmacies. The case originally started in Germany when the parallel importer Haemato Pharm discovered counterfeit packs in one batch of Xeplion 150mg. At least three batches of the product were found to contain both authentic packs and an unknown number of counterfeit packs. Haemato Pharm and a number of Danish parallel importers have restocked packs from the affected batches, and several parallel importers have confirmed they have counterfeit packs in stock. Manufacturer’s findings Janssen (i.e. the manufacturer of Xeplion 150mg) examined one of the counterfeit packs from the two initial batches affected, which were manufactured for sale in Bulgaria and Romania. The company found a number of ways that the counterfeit packs differed from authentic packs, including: (i) different shade of blue on the pack; (ii) outer packaging appeared older; and (iii) inner packaging was of a more recent date and contained needles with a different expiry date. The company also analysed the contents of a prefilled syringe in a counterfeit pack, revealing that "the syringe contained the correct active substance in the appropriate quantities". However, the agency highlighted that it could not be ruled out that the packs had been stored improperly given they were packed outside the legal chain – thereby making them counterfeit medicines. The market withdrawal of a fourth set of counterfeit batches of Xeplion 150mg injections was announced at the beginning of August. Janssen has analysed a total of seven counterfeit packs from the second batch and found that while the outer packaging had been falsified, the syringe, its contents and the enclosed needles were all authentic products. Overall, the DKMA considered that the risk that patients had been injected from a counterfeit pack was low. Batches that have an identified risk of falsification will remain under quarantine at the parallel importers and withdrawn from the market, and will not be released until their authenticity can be established. As per the DKMA’s request, information will be sent to psychiatrists and general practitioners about how to check for counterfeit Xeplion 150mg packs, as well as providing information about possible alternative products. * Other strengths of Xeplion are available, and another product with the same active substance is also available on the market. 1. Danish Medicines Agency. Counterfeit packs of the schizophrenia medicine Xeplion 150 mg. Internet Document : 25 Jul 2017. Available from: URL: https:// laegemiddelstyrelsen.dk/en/news/2017/counterfeit-packs-of-the-schizophrenia- medicine-xeplion-150-mg/. 2. Danish Medicines Agency. Withdrawal of one more batch of counterfeit packs of the schizophrenia medicine Xeplion 150 mg. Internet Document : 1 Aug 2017. Available from: URL: https://laegemiddelstyrelsen.dk/en/news/2017/ withdrawal-of-one-more-batch-of-counterfeit-packs-of-the-schizophrenia- medicine-xeplion-150-mg/. 0114-9954/17/1664-0001/$14.95 Adis © 2017 Springer International Publishing AG. All rights reserved Reactions 12 Aug 2017 No. 1664

Journal

Reactions WeeklySpringer Journals

Published: Aug 12, 2017

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