Zidovudine Oral Solution Safety Information update

09 Mar, 2018

Important information has been issued by ViiV Healthcare in order to highlight recent safety guidelines concerning zidovudine oral solution usage in neonates.

Below is the official letter from ViiV Healthcare:

The purpose of this letter is to highlight recent safety information regarding zidovudine oraI solution usage  in neonates.

Zidovudine Oral Solution (ZDV) is indicated for:

  • Human lmmunodeficiency Virus (HIV) infected adults and children in anti-retroviral combination therapy 
  • chemoprophylaxis in HIV-positive pregnant women (over 14 weeks of gestation) for prevention of maternal-foetal HIV transmission and for primary prophylaxis of HIV infection in newborn infant s.

A recent review of spontaneously reported cases of Zidovudine OraI Solution (OS) medication errors has identified a small number of an unintentional use of  tenfold overdose resulting in adverse outcomes in some cases. Most cases have been reported in paediatric patients <23 months and those requiring very small volumes of Zidovudine, primarily for use in neonates as a prevention measure. While the underlying reasons are unclear and multifactorial, in some cases, there is a clear link associated with the use of an inappropriate sized syringe and/or confusion between mg and ml.

It is of paramount importance that the appropriate size syringe is used depending on the indication far usage of Zidovudine OS.

Prescribers must ensure vigilance with syringe choice and use an appropriate  sized syringe, far  example  a 1 ml syringe when very small volumes are required .

To help mitigate the overdose risk, ViiV Healthcare will endeavour to ensure availability/licencing of Zidovudine OS neonate pack which include a 1ml syringe. Additionally, ViiV Healthcare has also revised labelling in the Zidovudine company Global Data Sheet. This labelling update will be submitted as locaI prescribing information/label updates to respective licences with an aim to provide additional guidance on the appropriate use of ZDV.

Please cascade this information as appropriate to your prescribers. Far further information , please contact:

Dr. Sonia Colcera, ViiV Healthcare S. r .l. -Via A. Fleming, 2 – 37135 Verona, ltaly (sonia.o.colcera@viivhealthcare.com)