MHRA March 2018

This largely does not apply to us.

Esmya (ulipristal acetate) for uterine fibroids: do not initiate or re-start treatment; monitor liver function in current and recent users.

We do not use initiate this medication for fibroids. Awareness of the monitoring has been passed on.

Review of liver safety An EU-wide review of Esmya started in December 2017 following reports of serious liver injury in women using the medicine. The review is ongoing; however, temporary safety measures were introduced in February 2018 to protect women’s health pending finalisation of the investigation. These measures were considered necessary following receipt of the fifth case of hepatic failure (the fourth that required liver transplantation).

Head lice eradication products: risk of serious burns if treated hair is exposed to open flames or other sources of ignition, eg, cigarettes

Pharmacists are encouraged to help the person with head lice and their parents or caregivers to consider the advantages and disadvantages of each treatment option (see NHS Choices page on Head lice and nits and the Head lice Clinical Knowledge Summary from NICE for more information on options for eradication). Cases of serious burns following combustion of hair Eight cases of serious burns associated with Hedrin 4% cutaneous solution have been reported to the MHRA since the product was licensed in 2005. Following the first reported case in 2007, warnings about risk of fires were added to the pack and patient information leaflet for Hedrin 4% cutaneous solution. Four cases were associated with a cigarette lighter or lighting of a cigarette, one with a lit cigarette, one with a candle, and 2 with adjusting a gas fire. There have been 2 further serious burns cases associated with other products. In 2006 a woman suffered serious burns when smoking during treatment. In 2017 another incident occurred when a child undergoing treatment came into contact with a naked flame, resulting in very serious burns.

Pregnancy registry for EllaOne


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