Letters and drug alerts sent to healthcare professionals in June 2019

Letters were sent about Myocrisin (sodium aurothiomalate), Cerliponase alfa (Brineura▼), Darzalex▼(daratumumab), retinoids▼, and febuxostat (Adenuric). A recall alert was issued for medicines that were taken out of the regulated medicines supply chain during distribution. Other alerts were issued about paracetamol tablets, docetaxel injection, Baxter potassium-chloride-containing intravenous infusions, and Emerade adrenaline auto-injectors.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 17 July 2019

• Therapeutic area: Anaesthesia and intensive care, Cancer, Cardiovascular disease and lipidology, Dentistry, Dermatology, Ear, nose and throat, Endocrinology, diabetology and metabolism, GI, hepatology and pancreatic disorders, Haematology, Immunology and vaccination, Immunosuppression and transplantation, Infectious disease, Neurology, Obstetrics, gynaecology and fertility, Ophthalmology, Paediatrics and neonatology, Pain management and palliation, Psychiatry, Radiology and imaging, Respiratory disease and allergy, Rheumatology, Urology and nephrology

Myocrisin permanent discontinuation

In June 2019, healthcare professionals were informed of the permanent discontinuation of Myocrisin (sodium aurothiomalate) Solution for Injection, also known as GOLD injections (see letter to healthcare professionals). This discontinuation is due to a shortage of active pharmaceutical ingredient (API) and is not due to any safety issue.

No new patient should commence treatment with Myocrisin injection. Prescribers should complete arrangements to transfer patients on Myocrisin to suitable therapeutic alternatives under medical supervision.

Other letters

In June 2019, the following letters were sent to healthcare professionals:

• Cerliponase alfa (Brineura▼): temporary change in packaging

• Darzalex▼(daratumumab) and risk of reactivation of hepatitis B virus

• Retinoids▼ (Acitretin, Adapalene, Alitretinoin, Bexarotene, Isotretinoin, Tretinoin, and Tazarotene): risk of teratogenicity and neuropsychiatric disorders

• Febuxostat (Adenuric): increased risk of cardiovascular death and all-cause mortality in patients treated with febuxostat in the CARES study

Drug alerts

In June 2019, the following drug alerts were issued:

FMD Alert: Class 2 (MDR 123-05/19). Issued 27 June 2019. Medicines have been taken out of the regulated medicines supply chain during distribution. The products have been parallel imported into the UK by B & S Healthcare from Italy and have been re-labelled in B & S Healthcare livery. See alert for list of products and batch numbers. The 3 products that are being recalled to patient level are Clexane 8000iu Injection 0.8ml; Neupro 4mg/24 hr patches; and Vimpat 100mg tablets. The products being recalled at pharmacy level are Dovobet Gel, Incruse Inhaler, Provisacor (Crestor) 10mg Tablets, Seebri Breezhaler, and Spiriva Inhalation Powder.

Class 2 Medicines Recall – Paracetamol 500mg Tablets, 1 x 1000 PL 04077/0001 (MDR 13-04/19). Issued 13 June 2019. Batches listed in the alert are being recalled because a small number of pots from each batch have been found to contain discoloured tablets due to fungal contamination.

Company led drug alert – Docetaxel Injection 160mg /16ml and Docetaxel Injection 20mg / 2ml. Issued 24 June 2019. Batches listed in the alert are being recalled after routine stability testing identified that levels of a known impurity, 10-oxo-docetaxel, may exceed the acceptable level at end of shelf-life.

Class 4 Drug Alert – Baxter Potassium Chloride containing intravenous infusions. Issued 3 June 2019. A small number of infusion bags have been found to be missing red text to highlight the presence of potassium chloride. Infusion bags in inventory should be inspected, and if found to be without the red print (example in alert) should be placed in quarantine. Home patients who use these products should be notified.

Emerade: medicines defect information

Healthcare professionals should also be aware of the Class 4 Medicines Defect Information for Emerade adrenaline auto-injectors, issued 11 July 2019.

Healthcare professionals are asked to contact patients supplied with an Emerade device and their caregivers to reinforce the advice to always carry TWO in-date adrenaline auto-injectors with them at all times (see Drug Safety Update issued in August 2017).

This advice follows detection of a risk of Emerade product failing to deliver a dose of adrenaline from the syringe due to blockage of the needle. For more information, see the alert online.

Additional advice to reiterate to patients is to:

• Check expiry date and replace the pen before it expires
• Use the auto-injector at first signs of anaphylaxis
• Call 999, ask for an ambulance and say anaphylaxis (pronounced as ‘anna-fill-axis’)
• Lie flat if possible with your legs up to keep your blood flowing
• Use second pen if still unwell after 5-15 minutes

The chance of a successful outcome is increased if there is prompt administration of adrenaline at the first signs of anaphylaxis. Even with an apparently successful response to adrenaline auto-injector administration, patients may relapse some hours later which underlines the importance that the emergency services should always be called.

Patients or their carers who experience any problem with Emerade failing to activate should report this via the MHRA’s Yellow Card Scheme and keep the pen for further examination.

Article citation: Drug Safety Update volume 12, issue 12: July 2019: 4.

Published 17 July 2019