New safety requirements were introduced for Esmya (ulipristal acetate), which is now indicated for the intermittent treatment of moderate to severe symptoms of uterine fibroids in women of reproductive age who are not eligible for surgery and for one course of pre-operative treatment for women of reproductive age who have these symptoms.

Initiation and supervision needs to be done by an experienced physician. Esmya is contraindicated in people with liver disorders. The risk of liver damage must be discussed with women prior to treatment and the patient must be aware of signs/symptoms of liver injury (including tiredness and yellowing of the skin). A patient card should be provided on dispensing and suspected adverse drug reactions recorded.

Daclizumab (Zinbryta) for adults with relapsing multiple sclerosis was suspended and recalled for safety reasons by the European Medicines Agency. Earlier this year the MHRA specified certain requirements for prescribing and ensuring the necessary liver function monitoring was in place in addition to ensuring the patient had signed an acknowledgement to confirm they had understood the risk of hepatic injury.

However, since then, daclizumab has been reported to cause serious inflammatory brain disorders, including encephalitis and meningoencephalitis, in patients with multiple sclerosis.

Patients still have a risk of hepatic injury six months after the last dose of the drug and should seek urgent medical attention if they develop severe headache or any symptoms of liver injury such as prolonged fever, abdominal pain, jaundice, dark urine, or unexplained nausea or vomiting. Monitoring for encephalitis should continue for 12 months following discontinuation of daclizumab.