Drug Safety Update

Volume 6, Issue 8 March 2013

Latest advice for medicines users

Aqueous cream: may cause skin irritation, particularly in children with eczema, possibly due to sodium lauryl sulfate content

Article date: March 2013
Summary
Aqueous cream may cause local skin reactions, such as stinging, burning, itching, and redness, when it is used as a leave-on emollient, particularly in children with atopic eczema. The reactions, which are not generally serious, often occur within 20 minutes of application but can occur later. Reactions may be due to the presence of sodium lauryl sulfate or other ingredients.
If a patient reports or shows signs of skin irritation with the use of aqueous cream, treatment should be discontinued and an alternative emollient that does not contain sodium lauryl sulfate should be tried.

Aqueous cream is a widely used product topically applied as an emollient for the symptomatic relief of dry skin conditions such as atopic eczema, and as a soap-substitute for skin washing.

Although aqueous cream is useful as a leave-on emollient in a substantial proportion of patients with eczema, it is known that in some patients, especially in children, it can cause skin reactions, such as stinging, burning, itching and redness.

In light of new information from the published literature all data on the benefits and risks of aqueous cream, particularly when used in children with eczema, have been recently reviewed in the UK.

Review outcome

Paediatric clinical guidelines from NICE and the National Eczema Society have reported that aqueous cream may be associated with skin reactions, such as burning, stinging, itching and redness, when used as a leave-on emollient but not when used as a wash product. The difference in the irritation potential in some patients may be related to the contact time with the skin, as soap substitutes are largely removed in the washing process.

An audit of 100 children attending a paediatric dermatology clinic reported that aqueous cream emollient was associated with an immediate skin reaction (stinging, burning, itching, and redness) within 20 minutes in 56% of exposures, compared with 18% with other emollients usedCork MJ et al (2003). An audit of adverse drug reactions to aqueous cream in children with atopic eczema. Pharm J 271(7277): 747 – 745. Furthermore, several studies reported alterations in skin physiology (thinning of the outermost layer of the skin and increased skin water loss) following application of aqueous cream as an emollient in adults, both with and without eczemaTsang M and Guy RH (2010). Effect of aqueous cream BP on human stratum corneum in vivo. Br J Dermatol 163(5): 954 – 958 Danby SG et al (2011). The effect of aqueous cream BP on the skin barrier in volunteers with a previous history of atopic dermatitis. Br J Dermatol 165 (2):329 –334. A summary of all the evidence reviewed is available in our public assessment report.

The causative agent may be sodium lauryl sulfate (SLS), contained in emulsifying wax which is one of the ingredients of aqueous cream. SLS functions as a stabiliser and cleansing agent, and is a known skin irritant. However, aqueous cream products often contain other ingredients such as chlorocrescol, cetostearyl alcohol and parabens, which may also cause or contribute to adverse skin reactions.

Despite the potential irritant effects reported in the literature, in clinical practice aqueous cream used both as an emollient and a wash-off soap substitute has been useful in a substantial proportion of patients with atopic eczema.

New information: on the basis of the review, aqueous cream labelling and information leaflet will be updated with a warning on the potential of local skin reactions, and SLS will be listed as an ingredient.

Advice for healthcare professionals:

  • Some patients with eczematous conditions, particularly children, may develop adverse skin reactions if aqueous cream is used as a leave-on emollient, often within 20 minutes of application. These reactions are not generally serious. However, patients and their carers should be warned of this risk during an eczema treatment consultation.

Further information:

MHRA Public Assessment Report 

MHRA patient article on aqueous cream

NICE Guideline Clinical Guideline: Atopic eczema in children (CG57)

Article citation: Drug Safety Update March 2013, vol 6, issue 8: A2.

References

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Page last modified: 09 April 2013