(2003; 14 pages)
ACETYLSALICYLIC ACID - MHRA confirms labelling change
UK. In a follow-up of the Medicines Control Agency’s Statement on acetylsalicylic acid (Aspirin) use (WHO Pharmaceuticals Newsletter No. 4, 2002), the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has posted, on its website, a notification that from 1 Oct 2003 all acetylsalicylic acid-containing products will be required to include the following statutory label warning: "Do not give to children under 16 years, unless on the advice of a doctor". This requirement follows an 8-week consultation process after which the Medicines Commission endorsed the advice of the UK Committee on Safety of Medicines that the warning was required. Professor Breckenridge, chairman of the Agency pointed out that there are plenty of alternative analgesic products for this age group not associated with Reye’s Syndrome and that "there is simply no need to expose those under 16 to the risk, however small".
Medicines and Healthcare products Regulatory Agency. Internet Document, 4 Apr 2003. Available from URL: http://www.mhra.gov.uk