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).

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

Other alerts

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