The European Medicines Agency has changed its recommendations for suppositories that contain terpenic derivatives. It now says that they should not be used in children younger than 30 months or in children who have experienced febrile convulsion, epilepsy, or recent anorectal lesions.
Terpenic derivatives include turpentine, camphor, cineole, niaouli, wild thyme, terpineol, terpine, citral, menthol and essential oils of pine needle, and eucalyptus. They are commonly used to treat mild bronchial disorders, especially coughs.
The decision follows a review by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) that identified potential risks of terpenic derivatives. Among infants and small children, convulsions were a particular concern, along with other neurological disorders. The agents can also cause precancerous anorectal lesions, leading to the recommendation that children who have a recent history of such lesions should not receive these agents.
The CHMP review was prompted by the French medicines agency, which was particularly concerned about the potential for serious neurological adverse effects. The French agency carried out a risk–benefit assessment, which the CHMP considered in addition to information obtained from the manufacturers and marketers of suppositories that include terpenic derivatives.
Suppositories with terpenic derivatives are currently marketed in Belgium, France, Luxembourg, Finland, Italy, Portugal, and Spain.