Letters and drug alerts sent to healthcare professionals in September 2019
Letters were issued about parenteral nutrition products, ranibizumab, ingenol mebutate gel, adrenaline auto-injectors, and fingolimod. Recall alerts were recently issued about ranitidine, aripiprazole, and bisacodyl.
Letters
Parenteral nutrition products for neonates and children below 2 years of age: protect from light
In September 2019, was sent to healthcare professionals and compounding centres.
A European review identified that light exposure may lead to increased peroxides and other degradation products in parenteral nutrition products containing amino acid and/or lipids, particularly those containing vitamins and trace elements. These particles can lead to severe adverse effects, especially in premature neonates who are at high risk of oxidative stress related to multiple factors including oxygen therapy, phototherapy, weak immune systems and inflammatory response with reduced oxidant defence. See letter for more information.
For administration to neonates and children below 2 years of age, parenteral nutrition products containing amino acids and/or lipids should be protected from light (containers and administration sets). This recommendation is already present in European paediatric parenteral nutrition guidelines by the European Society of Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) and the European Society for Clinical Nutrition and Metabolism (ESPEN).
Other letters
The following letters were sent to healthcare professionals in September 2019:
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– for more information see October 2019 Drug Safety Update article
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– for more information see October 2019 Drug Safety Update article
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– for more information see October 2019 Drug Safety Update article
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– for more information see October 2019 Drug Safety Update article
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Gilenya ▼ (fingolimod): contraindication in pregnant women and in women of childbearing potential not using effective contraception – for more information see September 2019 Drug Safety Update article
Alerts
Ranitidine
Class 2 Medicines recall: Zantac (ranitidine) Injection 50mg/2ml, Zantac Syrup 150mg/10ml, Zantac Tablets 150mg, Zantac Tablets 300mg (EL (19)A 24). Issued 8 October 2019. GlaxoSmithKline is recalling all unexpired stock of Zantac (ranitidine hydrochloride) prescription-only medicines (POM) from pharmacies as a precautionary measure due to possible contamination with an impurity N-nitrosodimethylamine (NDMA), which has genotoxic and carcinogenic potential.
Class 2 Medicines recall: Ranitidine Effervescent Tablets 150mg, Ranitidine Effervescent Tablets 300mg (EL (19)A/27). Issued 17 October 2019. Teva UK Ltd is recalling all unexpired stock of the listed products from pharmacies as a precautionary measure due to possible contamination with an impurity N-nitrosodimethylamine (NDMA), which has genotoxic and carcinogenic potential.
Other alerts
Class 2 Medicines Recall: Aripiprazole 1mg/ml oral solution EL (19)A/21. Issued 12 September 2019. Dr Reddy’s Laboratories (UK) is recalling batch number 050618 due to the potential for small particles of aripiprazole active material to be present, which may affect the efficacy of the product. Quarantine all remaining stock of the listed batch and return it to your supplier.
Class 2 Medicines Recall: Bisacodyl 10mg Suppositories EL (19)A/22. Issued 23 September 2019. Martindale Pharmaceuticals is recalling the batch number BUK901 due to an issue with homogeneity, which may result in individual suppositories containing too little or too much active substance. Quarantine all remaining stock of the listed batch and return it to your supplier.
Article citation: Drug Safety Update volume 13, issue 3: October 2019: 5.