MANDATORY MODIFICATION OF DENOMINATION AND THERAPEUTIC INDICATIONS FOR PRODUCTS CONTAINING LIDOCAINE, BENZOCAINE AND PRILOCAINE IN TOPIC FORM
The Chilean Institute of Public Health (ISP) issued on June 23, 2014 Resolution 2494, which establishes the mandatory modification of sanitary registrations of products containing lidocaine, benzocaine and prilocaine in topic formulations.
The measure was based on the risk that high doses of the a.m. drugs can pose to the pediatric population (adverse reactions and even death).
Currently there are 13 sanitary registrations in Chile of products containing lidocaine, benzocaine or prilocaine, and whose approved leaflets turned inadequate in the light of new scientific evidence.
The Marketing Authorization Holders of these products are obliged to eliminate the therapeutic indication related with “relief for the discomfort produced by teething”, and must indicate that the use in children under 3 is contraindicated.
Resolution 2494 established a 3-month period to implement the changes that will expire on October 23, 2014.