Class 4 Medicines Defect Information: Depo-Medrone with Lidocaine 40 mg/mL (1 mL and 2 mL vials) Pfizer Limited
Class 4 Medicines Defect Information: Class 4 Medicines Defect Information: Depo-Medrone with Lidocaine 40 mg/mL (1 mL and 2 mL vials – single vial preparations) Pfizer Limited
Drug alert number: EL (22)A/18
Date issued: 21 April 2022
Product description
Depo-Medrone with Lidocaine 40 mg/mL (1 mL and 2 mL vials – single vial preparations)
| Batch Number | Expiry Date | Pack Size | First Distributed |
| EL4771 | 30 September 2022 | 1X1ML | 23 January 2021 |
| FK6842 | 31 January 2023 | 1X1ML | 4 December 2021 |
| EK3997 | 31 May 2022 | 1X2ML | 2 December 2020 |
| FK6089 | 31 October 2022 | 1X2ML | 23 October 2021 |
| FN9557 | 31 August 2023 | 1X2ML | 15 January 2022 |
Pfizer Limited have informed The Medicines and Health products Regulatory Agency (MHRA) that an outdated version of the Patient Information Leaflet (PIL) has been included in the packaging of the above mentioned batches of Depo-Medrone with Lidocaine (Methylprednisolone acetate and Lidocaine hydrochloride) 40 mg/mL 1 mL and 2 mL vials (single vial presentations) to the UK market.
The detailed differences between the incorrect (PAA115821) and correct (PAA123046) PILs are listed in the Table below:
| Section/Parameter | Incorrect leaflet PAA115821 | Correct leaflet PAA123046 |
|---|---|---|
| Warnings and precautions | – | Peritonitis (Inflammation of the thin lining (peritoneum) around the gut and stomach) |
| Pregnancy and breast-feeding | If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine, as this medicine could slow baby’s growth. If you are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine, as small amounts of corticosteroid medicines may get into breast milk. | If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine, as this medicine could slow the baby’s growth. There is a risk associated with low birth weight of the baby; this risk can be reduced by administering a lower dose of the medicine. If you are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine, since lidocaine as well as small amounts of corticosteroid medicines are excreted into breast milk |
| Additionally, the correct leaflet contains language regarding change of the frequency of several possible side effects from ‘common’ to ‘not known’. This detailed information can be found in Appendix 1. | ||
Advice for healthcare professionals
Healthcare professionals should ensure that appropriate patient counselling takes place and patients are aware of the missing information. The impacted product is within product specification and there is no issue with product quality.
Additionally, healthcare professionals should be aware of the risk associated with low birth weight of the baby if used in pregnancy – Depo-Medrone with Lidocaine Suspension for Injection – Summary of Product Characteristics (SmPC) – (emc) (medicines.org.uk). This risk can be reduced by administering a lower dose of the medicine to patients who are pregnant. Healthcare professionals trained in the administration of this product should ask patients if they could be pregnant before receiving any doses.
Pfizer has agreed to share copies of the printed PIL upon request and these can be sourced by contacting Pfizer Medical Information on 01304 616161 or via email at medical.information@pfizer.com.
The correct PIL can be found on Patient Information Leaflet (medicines.org.uk).
View full alert here.
Further Information
If you have any questions, please contact Pfizer Medical Information Department on 01304 616161.
