The Medicines and Healthcare products Regulatory Agency (MHRA) is to look into the health risks and benefits of Strattera, a prescription-only medicine of Eli Lilly used to treat attention deficit hyperactivity disorder (ADHD). This follows new clinical trial data which identified an increased risk of suicidal thoughts and behaviour in children treated with Strattera.

According to an MHRA release, Strattera is not extensively used in the UK for the treatment of ADHD, but patients together with parents and guardians are being advised of this risk and should be made aware of any possible signs and symptoms.

Dr June Raine, Director of Medicines post-licensing at the MHRA said, “We are advising healthcare professionals that patients should be carefully monitored for signs of depression, suicidal thoughts or suicidal behaviour and referred for alternative treatment if necessary. Children who are doing well on this medication should continue their treatment. Those who experience any unusual symptoms, or are concerned, should speak to their doctor to discuss the best course of action.”

Earlier, US FDA had warned health care professionals in US about potential for severe liver injury following two reports in patients who had been treated with Strattera for several months.

FDA had asked the manufacturer, Eli Lilly to add a bolded warning about severe liver injury to the labelling. The company had agreed to alert health care professionals about the new information in a Dear Health Professional letter.