Gentamicin Injection and / or Infusion products - Caution-in-use notification

Notice type: Warning

Date: 09/11/2017

The HPRA has been made aware that some lots of gentamicin sulphate active pharmaceutical ingredient (API) used to manufacture certain batches of the finished products listed in Table 1 may contain higher than expected levels of histamine, which is a residual from the manufacturing process.

Precautionary recalls, to pharmacy level, are in progress for batches of two of these products due to elevated histamine levels in the API lots used in their manufacture – see Annex 1 below for batch details

All other Batches and Products (not subject to recall)

As these are essential medicines, for all other batches of the products listed in Table 1, recalls are not considered to be warranted at this time. This is due to lower histamine levels in the API lots used in their manufacture.

Advice to Healthcare professionals:

Healthcare professionals are advised to be cautious when using the above products. In particular, caution should be exercised when administering gentamicin concomitantly with medicines known to cause histamine release (for example, opioids and muscle relaxants).

Patients should be monitored closely for potential adverse reactions associated with increased levels of histamine, which may cause anaphylactoid (for example flushing, itching, urticaria and shortness of breath) or hypotensive reactions and increased heart rate. In particular, heart rate and blood pressure should be monitored throughout administration. Paediatric patients and patients with severe renal impairment may be more susceptible to the effects of exogenous histamine and should be closely monitored. Any suspected adverse reactions observed should be reported to the relevant Marketing Authorisation Holder and to the HPRA, via the online reporting system. 

Other actions:

Please bring this notice to the attention of all relevant healthcare professionals within your facility. If you have provided units of the products in Table 1 to any clinic, other pharmacy or any other healthcare facility, please immediately forward a copy of this notice to each one.

Advice to Patients and Carers:

Patients are not required to take any action at this time. If you have concerns about a medicine you may be using, please contact your healthcare professional.

Additional information:

This Caution-In-Use is an interim precautionary measure pending an assessment at European level of the potential risks presented by histamine in Gentamicin injectable and / or infusion products. Low residual levels of histamine are present in all such products as a result of the manufacturing process. This assessment is ongoing, and the patient monitoring measures outlined above should remain in place until such time as the HPRA can provide a further update on this issue.   
Further information will be provided via our website – www.hpra.ie  

Annex 1

Batches recalled

Recall letters have been issued (separate to this notice) by the respective MAH or supplier to customers supplied with the below-listed batches of these two products.

Gentamicin 40mg/ml Injection PA437/16/4

Gentamicin Intrathecal 5mg/ml Solution for Injection (PL 17780/0506 supplied as an exempt medicinal product)