Advertising complaint - Calpol Night (paracetamol & diphenhydramine hydrochloride) & CalCough Chesty (guaiphenesin) - Calpol website - June 2008

Information about Calpol Night and CalCough Chesty posted on the Calpol website by Johnson & Johnson (J&J) came to the attention of the MHRA. The MHRA was concerned that out of date information about the products was provided on the website.

The MHRA considered that the website was in breach of regulation 3A(1) of the Medicines (Advertising) Regulations 1994. The product information was not consistent with updated Summary of Product Characteristics (SPC) of the products as it continued to recommend and promote use of the products in the under 2 years age group for which they were no longer indicated. The MHRA issued safety update about the use of over the counter cough and cold medicines in children younger than 2 years on 27 March 2008.

Following contact from the MHRA, J&J promptly removed the website from public access and have confirmed that it will remain unavailable until all material has been updated in line with the current approved SPCs of the products. They also apologised for the error and provided reassurance that procedures are now in place to ensure website copy is appropriately and swiftly updated in response to SPC changes.

MHRA advice:
Companies should ensure that they have effective procedures in place to identify all existing materials, including websites, for review whenever an SPC is changed. Where changes relate to safety issues, companies must ensure that changes are expedited or materials withdrawn until this can be achieved.

Date case raised: 16 June 2008
Date action agreed: 23 June 2008
Date of publication: 18 July 2008