References: 1. Bikowski J, Pillai R, Shroot B. The position not the presence of the halogen in corticosteroids influences potency and side effects. J Drugs Dermatol . 2006;5(2):125-130. 2. Del Rosso J, Friedlander SF. Corticosteroids: options in the era of steroid-sparing therapy. J Am Acad Dermatol . 2005; 53(1 Suppl 1):s50-s58. 3. US Food and Drug Administration NDA 017765. Promius Pharma, LLC, Princeton, NJ: Aug 1977. 4. Rosenthal AL. Clocortolone pivalate: a paired comparison clinical trial of a new topical steroid in eczema/atopic dermatitis. Cutis . 1980;25(1):96-98. 5. Kircik LH. A study to assess the occlusivity and moisturization potential of three topical corticosteroid products using the skin trauma after razor shaving (STARS) bioassay. J Drugs Dermatol . 2014;13(5):582-585. 6. Cloderm [package insert]. Princeton, NJ: Promius Pharma, LLC; 2017.
For new medicines, the manufacturer then has to recruit children and newborns into trials (unless the medicine is not going to be used in children and newborns) and subsequently amend the PIL with the approved information. Older medicines may have been used effectively for many years in children without problems but the manufacturer has not been required to collect data and amend the licence. This does not mean that it is unsafe for children and young people to be prescribed such a medicine ‘off-licence/off-label’. However, if you are concerned about any conflicts of information, please discuss with your doctor, nurse or pharmacist.