Drug Safety Alerts UK MHRA (November 2020)
Drug Safety Alerts UK MHRA (November 2020)
Drug Safety Alerts UK MHRA (November 2020): UK Medicines & Healthcare products Regulatory Agency (MHRA) has provided 8 safety letters and 06 Drug alerts to healthcare professionals in November 2020.
Letters: Drug Safety Alerts UK MHRA (November 2020)
| Date | Medicinal Product/Device | Category | Safety alert |
| Oct-20 | Propofol 10 mg/ml (1%) Emulsion for Injection/Infusion | Letter | Batches with deactivated data in European Medicines Verification System (EMVS) |
| 04-Nov-20 | Ondexxya (andexanet alfa) | Letter | Avoid use of andexanet prior to heparinization |
| 10-Nov-20 | Gilenya (fingolimod) | DHPC | Updated recommendations to minimise the risk of drug-induced liver injury (DILI) |
| 12-Nov-20 | Tecfidera (dimethyl fumarate) | DHPC | Updated recommendations in the light of cases of progressive multifocal leukoencephalopathy (PML) in the setting of mild lymphopenia |
| 12-Nov-20 | Rozlytrek (entrectinib) 100 mg and 200 mg Capsules | Letter | Missing side effect in EU Patient lnformation Leaflet – “lncreased sensitivity of the skin to sunlight” is missing in the current Patient lnformation Leaflet (PIL), while it is listed in the Summary of Product Characteristics (SmPC) of the product. |
| 13-Nov-20 | Midazolam maleate (Epistatus 10mg in 1ml oromucosal solution, multidose bottle), unlicensed, emergency use medication for prolonged, acute, convulsive seizures | DHPC | Potential risk of incorrectly engaged child-resistant container closures |
| 30-Nov-20 | Gliolan (5-aminolevulinic acid, 5-ALA) | Letter | What to do in case of delayed surgery and information on fluorescence in non high-grade glioma |
| Nov-20 | Solu-Medrone (methylprednisolone as sodium succinate) 40 mg powder and solvent for solution for injection |
DHPC | Change from lactose-containing to a lactose-free formulation: risk of serious allergic reactions if formulations are confused |
DHPC: Direct Healthcare Professional Communication
Drug alerts: Drug Safety Alerts UK MHRA (November 2020)
| Date | Category | Medicinal Product/Device | Topic | Company Name |
| 09-Nov-20 | Class 4 | Kolanticon Gel 200ml, (PL 17509/0084), EL (20) A/51 | Medicines Defect Information | Intrapharm Laboratories |
| 11-Nov-20 | Class 2 | Sodiofolin 50mg/ml Solution for Injection 100mg/2ml, (PL 11587/0005), EL (20) A/52 | Medicines Recall | medac GmbH |
| 12-Nov-20 | Class 2 | Ancotil 2.5 g/250 ml Solution for Infusion, (PL 46302/0116), EL (20) A/53 | Medicines Recall | Mylan UK Healthcare Ltd |
| 25-Nov-20 | Class 2 | Abstral 200 microgram sublingual tablets, EL (20)A/54 | Medicines Recall | Kyowa Kirin Limited |
| 26-Nov-20 | Class 2 | Betahistine dihydrochloride 8mg and 16mg Tablets, EL (20)A/55 | Medicines Recall | Kent Pharmaceuticals |
| 26-Nov-20 | Class 2 | Largactil 50mg/2ml Solution for Injection, EL (20)A/56 | Medicines Recall | Aventis Pharma Limited |
For more information click here: https://www.gov.uk/drug-safety-update
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