In 2006, the Danish Medicines Agency examined the risk of nerve damage from the anaesthetics that dentists use for local anaesthesia. The examination was initiated due to a suspicion raised in Denmark that one of the active substances, articaine, caused a greater risk of nerve damage than other substances. In collaboration with the European Pharmacovigilance Working Party, PhVWP, we assessed that there was no basis for strengthening the warnings for using articaine, since the product information warns that long-term disruption of the nerve transmission may occur. We have followed the development since then, and we have decided to review the safety again.
The reason for this is that several articles have been published in this area by Danish researchers, among others. In the new review, we are going to include data from all countries where local anaesthetics with articaine are marketed.
The Danish Medicines Agency has therefore asked the marketing authorisation holder of the original articaine products to send an extraordinary safety update report by the end of 2011. Subsequently, we are going to review the new data and, in collaboration with the PhVWP, assess whether there is basis for strengthening the warnings for use of articaine.
Reports on articaine in Denmark
The Danish Medicines Agency's database of side effects contain 160 reports on adverse reactions from articaine that occurred from 2001-2005. The adverse reactions are mainly sensory impairment and nerve damage. Since 2005, we have seen a drop in the number of reports of new adverse reactions.
The chart below shows the number of reports of suspected adverse reactions listed according to the year they occurred. For comparison, the chart also shows the development of dentists' use of articaine.
Up until 1 October 2011, we have received two reports on suspected adverse reactions from articaine which occurred in 2011. In both cases, the patients have experienced sensory impairment after treatment with articaine.
The number of suspected adverse reactions reported to the Danish Medicines Agency for articaine. The chart shows which year a reported adverse reaction began. It also shows the use of articaine in dental practices in mL.
Articaine is the active substance in a local anaesthetic used in connection with dental treatment. The original products for articaine are Septanest® and Septocaine®, and these two products have been marketed in European countries since 1976 and in Denmark since 2001. The products are now marketed in more than 50 countries and they are used in more than 0.5 billion treatments worldwide.
Currently, there are five products with articaine on the Danish market: Dentocaine®, Septanest®, Septocaine®, Ubistesin® and Ubistesin Forte®.