Servier takes on CHMP advice

Servier has announced that the Committee for Medicinal Products for Human Use (CHMP) has advised that a warning on the risks of Drug Rash Eosinophilia and Systemic Symptoms (DRESS) should be added to the safety informing for Protelos.

CHMP, the European Medicines Agency committee, advised that a warning on the risks of DRESS should be introduced to the medicine’s prescribing information, stating that patients who experience symptoms of the syndrome should stop treatment and contact their doctor immediately.

DRESS is also known as hypersensitivity syndrome and is a rare but serious type of allergic reaction to some medicines.

CHMP had become aware of a growing number of reports of DRESS in patients taking Protelos as part of its continuous assessment of the medicine’s safety.

Since its launch in Europe in 2004, 16 cases of DRESS have been reported, with all cases being severe and requiring hospital treatment.

The committee concluded that there was a link between the use of Protelos and an increased risk of DRESS syndrome and called for prompt action.

Consequently Servier has provisionally introduced a warning through an urgent regulatory procedure as well as sending a letter to healthcare providers explaining the changes in recommendations of use for Protelos.