Alscreme 'Creme nr. 2' – information for Danish physicians

11 March 2010

The Danish Medicines Agency has been made aware that the cream called Alscreme 'Creme nr.2' which has been sold via the internet, has had a remarkably favourable effect on the treatment of eczema and various kinds of sores.

Against this background, we examined the content of the cream and established that it contains the potent corticosteroid clobetasol, which we announced on our website on 12 February 2010 and warned strongly against using the product (see our previous announcement in the factbox to the right).

In the meantime, we have become aware that the extract of the plant Aristolochia clematitis, which is also contained in the cream, is extremely toxic. Oral intake of Aristolochic acid is known to cause renal abnormalities involving hepatic impairment or failure and in the worst case scenario kidney cancer.  To the Danish Medicines Agency's knowledge there are no data suggesting that local use is associated with possible harmful effects, but since it may be assumed that the substance can be absorbed into the body in connection with the treatment of damaged skin, we are compelled to strengthen our warning, discouraging any use whatsoever.

Due to the cream's content of clobetasol, doctors should be aware that patients who have used the cream for a long-term period may need to switch to another corticosteroid-containing cream.

For further information, please contact Special Consultant Gitte Albæk Nielsen on tel.: +45 4488 9323 or Chief Medical Officer Marianne Orholm, tel. +45 4488 9740.

Danish Medicines Agency, 10 March 2010