MHRA Updates Flashcards
Valporate ▼
Valproate medicines must no longer be used in women or girls of childbearing potential unless a Pregnancy Prevention Programme is in place.
Applys to all premenopausal female patients unless the prescriber considers that there are compelling reasons to indicate that there is no risk of pregnancy.
Braltus (tiotropium)
Risk of inhalation of capsule if placed in the mouthpiece of the inhaler
Train patients to place the Braltus capsule in the correct chamber of the Zonda inhaler.
Reports of patients who have inhaled a Braltus capsule from the mouthpiece into the back of the throat, resulting in coughing and risking aspiration or airway obstruction.
Obeticholic acid (Ocaliva▼)
Risk of serious liver injury in patients with pre-existing moderate or severe hepatic impairment
Head lice eradication products
risk of serious burns if treated hair is exposed to open flames or other sources of ignition, eg, cigarettes
advise parents, caregivers and the person with head lice, if appropriate, that they should not smoke around treated hair and that it should be kept away from open flames or other sources of ignition, including in the morning after overnight application until hair is washed
always advise parents and caregivers and the person with head lice to read the instructions that come with treatments to ensure that they are used safely and correctly
Mycophenolate mofetil, mycophenolic acid
As a precautionary measure for male patients, it is now recommended that either the patient or their female partner use reliable contraception during treatment with mycophenolate medicines and for at least 90 days after stopping. Female patients of childbearing potential receiving mycophenolate should always use contraception.
Daclizumab (Zinbryta▼)
The use of daclizumab (daclizumab beta) is now restricted to adults with relapsing multiple sclerosis who have had an inadequate response to at least 2 other disease-modifying therapies (DMTs) and for whom other DMTs are contraindicated or unsuitable.
Recombinant human erythropoietins
treatment has been associated with very rare cases of life-threatening severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). Withdraw r-HuEPOs permanently in patients who develop severe skin reactions such as SJS or TEN.
