Letters and drug alerts sent to healthcare professionals in May 2019

Letters were sent about tofacitinib (Xeljanz▼), Trisenox (arsenic trioxide), lapatinib (Tyverb), direct-acting oral anticoagulants, and Lartruvo▼ (olaratumab). Alerts were issued about Epanutin (phenytoin) oral solution, Macopharma intravenous infusion bags, and Co-amoxiclav (amoxicillin/clavulanic acid).

• From: Medicines and Healthcare products Regulatory Agency
• Published: 19 June 2019

• Therapeutic area: Anaesthesia and intensive care, Cancer, Cardiovascular disease and lipidology, Endocrinology, diabetology and metabolism and Haematology
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  Infectious disease, Neurology, and Paediatrics and neonatology

Tofacitinib (Xeljanz▼): letter to provide additional detail on safety concerns

In the May 2019 Drug Safety Update, we informed you that following observation in a clinical study of an increased risk of pulmonary embolism and overall mortality associated with tofacitinib at the unauthorised dose of 10 mg twice-daily in rheumatoid arthritis, a safety review has started and new restrictions introduced.

A letter has now been sent to healthcare professionals to provide more detail on the preliminary results of the study upon which this advice was based. See letter for more information.

Epanutin (phenytoin) oral solution shortage – letter and alert

Epanutin (phenytoin) 30 mg/5 ml oral suspension will be out of stock from the week commencing 10 June 2019 until late July 2019.

All healthcare professionals who prescribe, dispense, or administer Epanutin oral suspension should consult the supply disruption alert issued by the Department of Health & Social Care (DHSC) on 6 June 2019.

Pfizer have obtained permission from the MHRA to import Canadian stock as an unlicensed product, branded as Dilantin (phenytoin) 30 mg/5 ml oral suspension – see letter to healthcare professionals.

There are small differences in the excipients: Dilantin-30 oral suspension contains amaranth (E123), whereas Epanutin oral suspension contains carmoisine (E122). No dosing adjustments are necessary but the Patient Information Leaflet (PIL) for Canadian Dilantin-30 oral suspension contains different dosing information compared to the Epanutin PIL. Patients should be counselled to remain on their prescribed dosing regimen of phenytoin and the need to consult their doctor if they are unsure.

Alternative phenytoin formulations (other than Dilantin 30mg/5ml oral suspension) are not directly interchangeable. Switching between alternative formulations may require specialist advice, support, or referral – see Drug Safety Update for advice about equivalence of antiepileptic drugs.

Other letters to healthcare professionals

• Trisenox (arsenic trioxide, 1 mg/ml concentrate for solution for infusion): replacement with import of arsenic trioxide injection 1 mg/ml (Phenasen) into the UK during the supply shortage

• Lapatinib (Tyverb): important update to the therapeutic indication and Summary of Product Characteristics

• Apixaban (Eliquis), dabigatran etexilate (Pradaxa), edoxaban (Lixiana▼) and rivaroxaban (Xarelto▼) are not recommended in patients with antiphospholipid syndrome due to possible increased risk for recurrent thrombotic events

• Lartruvo▼ (olaratumab): withdrawal of the EU marketing authorisation due to lack of therapeutic efficacy

Other alerts

• Company led drug alert - Macopharma intravenous infusion bags. Issued 7 May 2019. Macopharma is recalling certain batches of intravenous infusion bags as a precaution. This is due to the detection of metal particles in two infusion bags. See list in alert for recalled products, which include sodium chloride, glucose, and ringer lactate infusions.

• Class 2 Medicines Recall: Co-amoxiclav 125 mg/31.25 mg/5 ml and 25 mg/62.5 mg/5 ml Powder for Oral Suspension (MDR 24-05/19). Issued 13 May 2019. A potential packaging problem relating to poor seal adherence could cause clumping of the powder within the bottle. Remaining stocks of the impacted batches should be quarantined and returned to the original supplier.

For the latest alerts, including those from June 2019, see Alerts and recalls for drugs and medical devices.

Article citation: Drug Safety Update volume 12, issue 11: June 2019: 5.

Published 19 June 2019