The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for March 2011 (PDF).
This issue contains drug safety information advising that modafinil (Provigil®) is now exclusively indicated for the treatment of excessive sleepiness in adults with narcolepsy, with or without cataplexy. It is no longer indicated for shift-worker sleep disorder and obstructive sleep apnoea. Patients with these conditions are advised to see their doctor.
Additional information is provided to promote safer use including avoiding use in those with uncontrolled hypertension or cardiac arrhythmias, children up to 18 years old and women who are pregnant or breast feeding. It is also recommended that a baseline ECG is performed before starting treatment and that blood pressure and pulse rate are monitored during treatment.
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.