The cause is unknown, but a number of studies suggest a link between the development of Reye's syndrome in children and the use of aspirin to treat the viral illness which precedes it. These studies do not prove that aspirin causes Reye’s syndrome but may aggravate it. Other chemical substances including insecticides and emulsifiers have also been implicated but the evidence that these are involved is controversial. Risk factors for adult Reye's syndrome have not been studied.
Because there are alternatives, there is no need to use aspirin for feverish illnesses in childhood. Since 1986, aspirin preparations have been labelled with differing warnings. The latest advice from the Medicines and Healthcare products Regulatory Agency (MHRA) which came into force on 1st October 2003, requires all aspirin products to carry a warning that children under 16 should not take aspirin unless on the advice of a doctor. The warning that appears on the Carton/Label and Patient Information Leaflet is as follows.
Carton/Label: Aspirin Products
DO NOT GIVE TO CHILDREN UNDER 16 YEARS, UNLESS ON THE ADVICE OF A DOCTOR
Patient Information Leaflet: Aspirin Products
THERE IS A POSSIBLE ASSOCIATION BETWEEN ASPIRIN AND REYE’S SYNDROME WHEN GIVEN TO CHILDREN. REYE’S SYNDROME IS A VERY RARE DISEASE WHICH CAN BE FATAL. FOR THIS REASON ASPIRIN SHOULD NOT BE GIVEN TO CHILDREN AGED UNDER 16 YEARS, UNLESS ON THE ADVICE OF A DOCTOR
On 23rd April 2009 the MHRA issued precautionary advice for topical oral pain relief gels containing salicylate salts. The main products affected are Bonjela and Bonjela Cool Mint Gel. This is due to salicylate salts having the same affect on the body as aspirin. The new advice recommends these products are not used in those under 16 years of age. This is a precautionary measure only and there are no new safety concerns.
Carton/Label, Tube, Patient Information Leaflet: Topical Oral Pain Relief Gels
DO NOT GIVE TO CHILDREN AND ADOLESCENTS UNDER 16 YEARS OF AGE THIS IS BECAUSE THERE IS A POSSIBLE ASSOCIATION/ LINK * BETWEEN SALICYLATES AND REYE’S SYNDROME WHEN GIVEN TO CHILDREN. REYE'S SYNDROME IS A VERY RARE DISEASE WHICH AFFECTS THE BRAIN AND LIVER AND CAN BE FATAL.