Calcium gluconate injection in small-volume glass containers: new contraindications due to aluminium exposure risk

Aluminium can be leached from glass after contact with calcium gluconate solution, leading to a risk of exposure to aluminium. Accumulation of aluminium might have adverse effects on bone mineralisation and neurological development in children and those with renal impairment. Calcium gluconate injection packed in small-volume glass containers is now contraindicated for use as repeated or prolonged treatment, including as an intravenous infusion, in children younger than 18 years and in patients with renal impairment. To limit the exposure of patients to aluminium, especially in those with impaired renal function and in children, calcium gluconate injection in small-volume glass containers is also contraindicated in the preparation of total parenteral nutrition solutions. Use of calcium gluconate injection packed in plastic containers is recommended to reduce aluminium burden in vulnerable patients

Article date: August 2010

Authorised use of calcium gluconate injection

Parenteral administration of calcium gluconate is currently authorised where the pharmacological action of a high calcium ion concentration is required—eg, in acute hypocalcaemia, cardiac resuscitation, and in some cases of neonatal tetany.

Calcium gluconate injection in small-volume glass containers: risk of aluminium exposure

Aluminium can be leached from glass after contact with calcium gluconate solution, leading to a risk of exposure to aluminium which might have adverse effects on bone mineralisation and neurological development in children and those with renal impairment. Calcium gluconate injection packed in small-volume glass containers is now contraindicated for use as repeated or prolonged treatment, including as an intravenous infusion, in children younger than 18 years and in patients with renal impairment. To limit the exposure of patients to aluminium, especially in those with impaired renal function and in children, calcium gluconate injection in small-volume glass containers is also contraindicated in the preparation of total parenteral nutrition (TPN) solutions. Small volume refers to the licensed ampoules, which are 10 mL.

The Paediatric Medicines Expert Advisory Group to the Commission on Human Medicines has considered information on the content of aluminium in these preparations. Taking into account evidence that aluminium accumulation might have adverse effects on bone mineralisation and neurological development in children and those with renal impairment, these products should no longer be used for repeated or prolonged treatment of children or those with impaired renal function.

The Group noted that calcium gluconate injection packed in plastic containers is not likely to present a similar risk as the containers do not contain high levels of aluminium.

TPN

The Group was made aware that calcium gluconate injection in small-volume glass containers is also used to provide the calcium element of TPN solutions, although this is not a licensed use. They advised that use of these products for the preparation of TPN should be contraindicated due to the risk of aluminium exposure, especially in vulnerable populations.

Given the use of both licensed and unlicensed products to prepare TPN solutions, we are in discussion with relevant parties within the NHS and other sectors to encourage a transition to the use of calcium gluconate injection packed in containers other than glass.

Advice for healthcare professionals

Do not use calcium gluconate injection packed in small-volume glass containers for repeated or prolonged treatment, including as an intravenous infusion, in children younger than 18 years or in patients with renal impairment.
To limit the exposure of patients to aluminium, especially in those with impaired renal function and in children, do not use calcium gluconate injection in small-volume glass containers in the preparation of TPN solutions.
Use of calcium gluconate injection packed in plastic containers is recommended to reduce aluminium burden in vulnerable patients.

 

Article citation: Drug Safety Update Aug 2010, vol 4 issue 1: A2.

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