Letters and drug alerts sent to healthcare professionals in January 2019

Letters were sent to healthcare professionals about Lartruvo▼ (olaratumab), quadrivalent influenza vaccine (split virion, inactivated), SGLT2 inhibitors, and carbimazole and thiamazole (synonym: methimazole)-containing products. Class 2 medicines recalls were issued for batches of irbesartan/hydrochlorothiazide and irbesartan tablets.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 18 February 2019

• Therapeutic area: Anaesthesia and intensive care, Cancer, Cardiovascular disease and lipidology, Dermatology, Endocrinology, diabetology and metabolism, GI, hepatology and pancreatic disorders, Immunology and vaccination, Infectious disease, Obstetrics, gynaecology and fertility

Lartruvo▼ (olaratumab): no new patients to be prescribed due to study showing no clinical benefit

In January 2019, a letter was sent to prescribers and dispensers of Lartruvo, indicated for advanced soft tissue sarcoma, to announce that, following the results of a clinical trial (ANNOUNCE) showing no survival benefit:

• no new patients should be prescribed Lartruvo
• while further assessment of the study results is ongoing, treatment with Lartruvo may continue in patients who experience clinical benefit

Lartruvo is indicated in combination with doxorubicin for the treatment of adult patients with advanced soft tissue sarcoma who are not amenable to curative treatment with surgery or radiotherapy and who have not been previously treated with doxorubicin. Continued approval is contingent upon verification of clinical benefit in the confirmatory trial ANNOUNCE.

The global phase 3 study (ANNOUNCE) of Lartruvo in combination with doxorubicin in patients with advanced or metastatic soft tissue sarcoma (STS) did not show benefit in terms of survival and progress-free survival compared with doxorubicin, a standard of survival care treatment. See the letter for the study data.

Other letters sent to healthcare professionals

In January 2019 the below letters were also sent to healthcare professionals:

• Sodium-Glucose-Co-Transporter 2 inhibitors (SGLT2i): risk of Fournier’s gangrene (necrotising fasciitis of the perineum)

• Supply of Standard Export pack of Quadrivalent Influenza Vaccine (split virion, inactivated) suspension for injection in a prefilled syringe PL 46602/0017 - Lot R3J824V, Expiry 31/08/2019 – Single Packs

• Carbimazole or thiamazole (synonym: methimazole)-containing products: (1) risk of acute pancreatitis and (2) strengthened advice on contraception]

Drug alerts

Class 2 Medicines Recall: Actavis Group PTC EHF - recall of batches of Irbesartan/Hydrochlorothiazide 300/12.5mg Film-coated Tablets and Irbesartan/Hydrochlorothiazide 150/12.5mg Film-coated Tablets. Issued 3 January 2019. Actavis Group PTC EHF is recalling the listed batches from pharmacies as a precautionary measure due to possible contamination with N-nitrosodiethylamine (NDEA).

Class 2 Medicines Recall: Macleods Pharma UK Limited - Irbesartan 150mg Film-coated tablets, PL 34771/0079 (MDR 94-06/18). Issued 21 January 2019. Macleods Pharma UK Limited is recalling the listed batches from pharmacies as a precautionary measure due to possible contamination with N-nitrosodiethylamine (NDEA).

Article citation: Drug Safety Update volume 12, issue 7: February 2019: 4.

Published 18 February 2019