MHRA warnings

Question 1

MHRA warning for thiopurines (e.g., azathioprine, mercaptopurine)

Answer 1

Risk of intrahepatic cholestasis of pregnancy - increased plasma bile acid levels resulting in:
- Maternal itching without rash on hands and feet
- Increased risk of still birth and spontaneous pre-term birth.

Question 2

MHRA warning for SABAs

Answer 2

Excessive use of SABA to relieve acute asthma symptoms may mask progression of the underlying disease and contribute to an increased risk of severe and potentially life-threatening asthma exacerbations.
Do not use SABA without concomitant ICS.

Question 3

MHRA warning for MR opioids

Answer 3

Prolonged relief opioids e.g., MR morphine can no longer be used for relief of post-op pain due to the increased risk of persistent post-operative opioid use (PPOU) and opioid-induced ventilatory impairment (OIVI).

Question 4

GLP-1 agonists MHRA warnings

Answer 4

Risk of pulmonary aspiration in patients who undergo surgery or procedures with general anaesthesia or deep sedation.
Risk of misuse.

Question 5

Bromocriptine MHRA warning

Answer 5

Monitor BP when prescribing bromocriptine for prevention of post-partum lactation (e.g., due to maternal HIV, neonatal death). Contraindicated in uncontrolled hypertension, pre-eclampsia, or history of CVD.

Question 6

Valproate MHRA warnings

Answer 6

• Association between valproate use by men and an increased risk of neurodevelopmental disorders in their children. Recommend effective contraception during valproate treatment and for at least 3 months after stopping valproate.
• Valproate must not be started in new patients (male or female) younger than 55 years, unless two specialists independently consider and document that there is no other effective or tolerated treatment.
• Dispense in original full packs.

Question 7

Epimax ointment MHRA warning

Answer 7

Epimax Ointment and Epimax Paraffin-Free Ointment can harm the eyes if used on the face. Do not prescribe these ointments for use on the face. Tell patients to wash their hands and avoid touching their eyes after using these products.

Question 8

Tramadol MHRA alert

Answer 8

Taking warfarin and tramadol together can cause harmful drug interactions, which can raise the International Normalised Ratio (INR), and result in severe bruising and bleeding, which in some patients could be fatal.

Question 9

Montelukast MHRA warning

Answer 9

Risk of neuropsychiatric reactions in all patients including children and adolescents e.g., sleep disorders, hallucinations, anxiety and depression, as well as changes in behaviour and mood.

Question 10

Pseudoephedrine MHRA warning

Answer 10

Rare risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). Look out for thunderclap headache, sudden onset of nausea and vomiting, confusion, seizures, visual disturbances,

Question 11

Omega-3 MHRA warning

Answer 11

Omega-3-acid ethyl ester medicines (Omacor/Teromeg 1000mg capsules): dose-dependent increased risk of atrial fibrillation (“common” AE) in patients with established cardiovascular diseases or cardiovascular risk factors.

Question 12

Isotretinoin MHRA warning

Answer 12

• 2 independent prescribers need to agree the initiation of isotretinoin in patients under 18 years
• New counselling requirements about potential mental health and sexual function side effects. Assessment of mental health and sexual function before starting treatment and monitoring of mental health and sexual function during treatment.

Question 13

Calcium salts MHRA warning

Answer 13

Calcium chloride and calcium gluconate are used to stabilise the myocardium and prevent cardiac arrest in patients experiencing severe hyperkalaemia. However, the two salts are not equivalent in terms of calcium dose. Underdosing of can result in fatal hyperkalaemia.

Question 14

NSAIDs MHRA warning

Answer 14

• Prolonged NSAIDs from week 20 of pregnancy associated with an increased risk of oligohydramnios (low levels of amniotic fluid surrounding the baby) and fetal renal dysfunction.
• NSAIDs are contraindicated during the last trimester (28 weeks) of pregnancy due to the risk of premature closure of the ductus arteriosus and renal dysfunction in the fetus and due to prolongation of maternal bleeding time and inhibition of uterine contractions during labour

Question 15

Febuxostat MHRA warning

Answer 15

Caution in patients with pre-existing major CVD especially with high urate crystal and tophi burden or those initiating urate-lowering therapy, due increased risk of cardiovascular death.

Question 16

Nitrofurantoin MHRA warnings

Answer 16

Risk of pulmonary and hepatic toxicity

Question 17

Terlipressin MHRA warning

Answer 17

• In patients with type 1 hepatorenal syndrome may cause serious or fatal respiratory failure
• Increased risk of sepsis and septic shock.