LONDON, 17 May (APM) - The EU drug regulator's safety committee recommended on Friday that doctors must not prescribe the 10 mg twice daily dose of Pfizer's Xeljanz (tofacitinib) for certain autoimmune diseases in patients who are at high risk of blood clots in the lungs.
These include patients who have heart failure, cancer, inherited blood clotting disorders or a history of blood clots, as well as patients who take combined hormonal contraceptives, are receiving hormone replacement therapy or are undergoing major surgery, the European Medicines Agency's PRAC said.
In addition, doctors should consider other factors that may increase the risk of blood clots in the lungs including age, obesity, smoking or immobilisation, the PRAC said in a statement
Xeljanz is currently approved for treating rheumatoid arthritis, psoriatic arthritis and severe ulcerative colitis.
The PRAC’s recommendation follows results from an ongoing study (study A3921133) in patients with rheumatoid arthritis. This showed an increased risk of blood clots in the lungs and death when the 10 mg twice daily dose was used, which is double the recommended dose for rheumatoid arthritis, it added.
The new advice means that, since 10 mg is the only recommended starting dose for ulcerative colitis, patients with this condition who are at high risk of blood clots must not be started on Xeljanz. Patients at high risk currently taking this dose for any condition must be switched to alternative treatments, it said.
Patients should not stop or change their dose of Xeljanz without talking to their doctor. They should seek medical attention immediately if they experience symptoms such as difficulty breathing, pain in the chest or upper back and coughing up blood, which could indicate the presence of a blood clot in the lungs, it said.
Ban cough medicines containing fenspiride because of heart risks
The PRAC is also recommending banning fenspiride medicines in Europe because they can cause heart rhythm problems.
In its review, the PRAC considered all the available evidence, such as cases of QT prolongation and torsades de pointes (abnormalities of the heart’s electrical activity that may lead to heart rhythm disturbances) in patients using these medicines, results of laboratory studies, data from published literature and stakeholder input.
Healthcare professionals should no longer prescribe fenspiride medicines and should advise their patients to stop taking them, it said.
Patients are advised to stop taking these medicines and contact their doctor or pharmacist for advice on alternative treatments, if needed, it advises.