Letters and drug alerts sent to healthcare professionals in March 2019

Letters were sent about Xeljanz▼ (tofacitinib), ranitidine, Nulojix (belatacept), fluoroquinolone antibiotics, Genvoya▼, Stribild▼, Tybost, and belimumab (Benlysta▼). Drug alerts were issued about Accord losartan potassium containing products and Ozurdex implants.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 16 April 2019

• Therapeutic area: Anaesthesia and intensive care, Cancer, Cardiovascular disease and lipidology, Dentistry and Dermatology
  Show 12 more
  Ear, nose and throat, Endocrinology, diabetology and metabolism, GI, hepatology and pancreatic disorders, Haematology, Infectious disease, Neurology, Nutrition and dietetics, Obstetrics, gynaecology and fertility, Ophthalmology, Psychiatry, Respiratory disease and allergy, and Urology and nephrology

Letters

• Xeljanz▼ (tofacitinib): Increased risk of pulmonary embolism and mortality in rheumatoid arthritis patients receiving 10 mg twice daily in a clinical trial

• Ranitidine 150 mg tablets: Batch number and expiry date prompts ‘LOT’ and ‘EXP’ printed in German on outer (carton) packaging

• Nulojix (belatacept): Update on the temporary restriction in supply (initiated in March 2017)

• Fluoroquinolone antibiotics: risk of disabling, long-lasting and potentially irreversible side effects – new restrictions on prescribing for ciprofloxacin, levofloxacin, moxifloxacin, and ofloxacin for safety reasons

• Genvoya▼ (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide), Stribild▼ (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil), Tybost (cobicistat): Increased risk of treatment failure and increased risk of mother-to-child transmission of HIV infection due to lower exposure of elvitegravir and cobicistat during the second and third trimesters of pregnancy

• Belimumab (Benlysta▼): Increased risk of serious psychiatric events (depression, suicidal ideation or behaviour, or self-injury)

Drug alerts

Recall of Accord losartan potassium

Accord Healthcare losartan potassium containing products are being recalled due to contamination with N-nitroso-N-methylamino butyric acid (NMBA).

Class 2 Medicines recall: Accord Healthcare Limited - Losartan Potassium 50mg Film-coated Tablets, PL 20075/0022 and Losartan Potassium 100mg Film-coated Tablets, PL 20075/0023

Actions for healthcare professionals:

• Stop supplying the batches listed in the alert immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process
• If you receive queries about this issue from patients, advise them to continue taking their medication as the health risk of discontinuing the medicine is higher than the potential risk presented by the contaminant. A treatment review is not necessary until the next routine appointment
• We do not anticipate any shortages of losartan potassium containing products. In case of local supply issues, patients should be advised to speak to their doctor to discuss alternative treatments

The MHRA continues to thoroughly investigate nitrosamine contamination alongside the European Medicines Agency (EMA) and the European Directorate for the Quality of Medicines (EDQM). We will continue to monitor the situation in the UK and consider what actions are necessary to protect public health.

Other drug alerts

In March 2019, a company-led drug alert was issued for Ozurdex implants (MDR 95-08/18) due to the possibility that a single loose silicone particle of approximately 300 microns in diameter may become detached – see also letter to healthcare professionals from February 2019.

For the latest alerts, including those from April 2019 on Nutriflex Omega Special 2500ml, chloramphenicol 0.5% W/V antibiotic eye drops, and zoledronic acid 5 mg solution for infusion, see Alerts and recalls for drugs and medical devices.

Article citation: Drug Safety Update volume 12, issue 9: April 2019: 6.

Published 16 April 2019