Letters sent to healthcare professionals in January 2018

Letters were sent about Buccolam (midazolam), misoprostol vaginal delivery system (Mysodelle), noradrenaline, Relenza (zanamivir), mycophenolate mofetil/mycophenolic acid, Flolan, and Fludara.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 6 February 2018

• Therapeutic area: Anaesthesia and intensive care, Cancer, Cardiovascular disease and lipidology, Dentistry, Haematology, Immunosuppression and transplantation, Infectious disease, Neurology, Obstetrics, gynaecology and fertility, Paediatrics and neonatology, Respiratory disease and allergy, Rheumatology, Urology and nephrology

In January 2018, an update was sent to healthcare professionals about a defect with the antiepileptic drug Buccolam (midazolam) and a risk of inhalation/ingestion of tip cap of prefilled plastic syringes (see press release from MHRA).

Pharmacists are encouraged to proactively communicate the instructions included in this letter to parents and caregivers (and patients if appropriate) who have been dispensed Buccolam and who have not already been made aware. Further supplies of Buccolam will contain these instructions, which are to be provided with every pack dispensed.

In addition, in January 2018 the following letters were sent to relevant healthcare professionals:

• Misoprostol vaginal delivery system (Mysodelle): Reports of excessive uterine tachysystole (contractions) that may not respond to tocolytic treatment

• Noradrenaline (Norepinephrine) 0.08 mg/mL (4 mg in 50 mL) solution for infusion in a vial: potential risk of medication errors

• Relenza (zanamivir): supply of Taiwanese stock; give patients UK leaflet

• Mycophenolate mofetil (MMF)/mycophenolic acid (MPA): amended recommendations for contraception in male patients

We are also aware of the following two letters, sent to relevant healthcare professionals in December 2017:

• Flolan (epoprostenol sodium) and leakage of administration sets containing PETG

• Fludara 10 mg film-coated tablets: Polish language blisters

Article citation: Drug Safety Update volume 11 issue 7; February 2018: 4.

Published 6 February 2018