Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Warfarin | Solfarin | 4.4 Special warnings and precautions for use. 4.8 Undesirable effects | Warnings related to benzoic acid, addition of sodium content, anticoagulant-related nephropathy, | Nov,2024 |
| Carbetocin | Pabal RTS | 4.8 Undesirable effects | Hypersensitivity (including anaphylactic reaction), bradycardia which can lead to cardiac arrest | Nov,2024 |
| Measles Virus (SCHWARZ) Live Attenuated,Mumps Virus (JERYL LYNN, STRAIN RIT 4385) Live Attenuated,Rubella Virus (WISTAR RA 27/3) Live Attenuated | M.M.R II | 4.6 Pregnancy, lactation and fertility | Safety information during pregnancy | Nov,2024 |
| Sodium Alginate,Calcium Carbonate,Sodium Bicarbonate | Gaviscon Double Action | 4.4 Special warnings and precautions for use. 4.6 Pregnancy, lactation and fertility | Soidum content. Safety information in breastfeeding women and effect on fertility | Nov,2024 |
| Vinorelbine tartrate | Navelbine | 4.4 Special warnings and precautions for use | Pulmonary embolism, posterior reversible encephalopathy syndrome and Skin hyperpigmentation | Nov,2024 |
| Alirocumab | Praluent | 4.8 Undesirable effects | Added safety information in pediatrics | Nov,2024 |