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Outcome of European procedure on use of lidocaine (lignocaine) in food-producing species
Notice type:
Advisory
Date:
10/06/2015
In December 2012 the Dutch Medicines Evaluation Board
requested the opinion
of the European Medicines Agency on the potential risk of the metabolite 2,6-xylidine for the consumer resulting from the use of lidocaine in food producing species and on the need for risk management measures.
Product name or type:
Local anaesthetics containing lidocaine (lignocaine)
Authorisation Number:
VPA 10999/52/1 Norocaine, VPA 10823/19/1 Lignocaine & Adrenaline
Active Substance:
Lidocaine (formerly known as lignocaine)
Prescription Required:
Yes
Target Audience:
Veterinary practitioners
Problem Or Issue:
Lidocaine injection is a local and regional anesthetic. It has been used in veterinary medicine for several decades. New data on 2,6-xylidine metabolite of lidocaine was referred by the Dutch authorities to the European Medicines Agency for clarification on the potential risk to consumers. The Committee for Medicinal Products for Veterinary Use (CVMP) of the European Medicines Agency considered the matter. In April 2015 the CVMP concluded that:
• The risk of consumer exposure to residues of lidocaine in horse meat is considered very low. No risk mitigation measures are considered necessary.
• For cattle, considering that the estimated amount of lidocaine residues in the cow’s body after treatment is negligible it can be considered that the minimum cascade withdrawal period of 28 days is appropriate. Therefore, no new risk mitigation measures are needed.
• Regarding milk, to ensure that total residues in the cow’s body are below the safety level requires a withdrawal period of 15 days between use of lidocaine and the taking of milk for human consumption. At this time point there is no risk to the consumer.
• For pigs, the minimum cascade withdrawal period of 28 days is sufficient to ensure elimination of residues to a safe level. Moreover considering that the use for castration takes place at a time far from slaughter, the risk to the consumer is considered negligible.
Background Information Or Related Documents:
In December 2012 the Dutch Medicines Evaluation Board
requested the opinion
of the European Medicines Agency on the potential risk of the metabolite 2,6-xylidine for the consumer resulting from the use of lidocaine in food producing species and on the need for risk management measures.
Actions To Be Taken:
When using lidocaine in food-producing animals, veterinary practitioners should be apply withdrawal periods of at least:
15 days for milk
28 days for slaughter
Further Information:
Opinion of the CVMP on potential risk for the consumer resulting from the use of lidocaine in food producing species
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Date Printed: 25/04/2024