If patients develop a rash they should stop taking the drug and consult their doctor immediately. Once treatment has been stopped it should not be re-introduced.
The MHRA advice follows a European Medicines Agency (EMEA) recommendation that the product information for Protelos should be changed to include warnings on severe hypersensitivity syndromes as an urgent measure.
Up to 16 November 2007, the EMEA had received 16 reports of ‘drug rash with eosinophilia and systemic symptoms (DRESS)’ in patients treated with Protelos/Osseor (brand name in some other countries), two of which were fatal.
Further information: MHRA