Letters and drug alerts sent to healthcare professionals in January 2021

A summary of letters and drug alerts recently sent to healthcare professionals.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 18 February 2021

• Therapeutic area: Cancer, Infectious disease, Obstetrics, gynaecology and fertility, Pain management and palliation and Respiratory disease and allergy

Letters

In January 2021, the following letters were sent or provided to relevant healthcare professionals:

• Voriconazole 200 mg powder for solution for infusion: Interim supply arrangements to mitigate supply disruption
• Esmya (ulipristal acetate) 5mg: Indications for uterine fibroids restricted due to concerns of severe liver injury
• Accord Thalidomide 50mg hard capsules: Pregnancy Prevention Programme to minimise the risk of teratogenicity. Thalidomide is a powerful human teratogen that can cause severe and life-threatening birth defects and must not be used during pregnancy. All thalidomide medicines must be used within a pregnancy prevention programme (PPP). To facilitate the implementation of the PPP during the coronavirus (COVID-19) pandemic, we have published temporary guidance.

For letters relating to medicines with a centralised European license with respect to Northern Ireland, see the European Medicines Agency website.

Drug alerts

Company led medicines recall: Instanyl 100mcg nasal spray solution (EU/1/09/531/015). Issued 18 January 2021. A single batch of Instanyl 100mcg nasal spray solution is being recalled due to cracked vials identified during bulk inspection and release testing. There is a low potential for cracking of the glass vials and consequent microbial contamination and the batch is being recalled as a precautionary measure. Remaining stock of these batches should be quarantined and returned for replacement stock where available.

Company led medicines recall: Respreeza 1,000 mg powder and solvent for solution for infusion (EU/1/15/1006/001). Issued 20 January 2021. Specific batches of Respreeza 1,000mg powder and solvent for infusion have been identified to be at risk of microbial contamination due to failure of HEPA filters at the manufacturing site. All remaining stock should be quarantined and returned.

Article citation: Drug Safety Update volume 14, issue 7: February: 6.

Published 18 February 2021