Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Infliximab | Ixifi | "4.3 Contraindications 4.4 Special Warnings and Special Precautions for Use 4.6. Fertility, pregnancy and lactation 4.8 Undesirable effects" | "Updated safety information and contraindications related to use iof Ixifi in patients with moderate or severe heart failure at doses >5 mg/kg Updated safety information in pediatric patients Updated safety information in Pregnant patients Updated undesirable effects ""Immunogenicity, Interstitial lung disease """ | Jul, 2024 |
| Rosuvastatin,Ezetimibe | Lipocomb | 4.5. Interactions with other medicinal products | Interaction with Ticagrelor, Teriflunomide, Capmatinib, Fostamatinib, and Febuxostat | Jul, 2024 |
| Sodium Glycerophosphate Hydrated | Glycophos | 4.8 Undesirable effects | Addition of undesirable effects identified in post-marketing setting | Jul, 2024 |
| Perindopril Arginine,Indapamide,Amlodipine Besilate | Triplixam | "4.4 Special Warnings and Special Precautions for Use 4.8 Undesirable effects" | "Hypokalaemia found in association with low serum magnesium concentration can be refractory to treatment unless serum magnesium is corrected. Addition of hypochloraemia, hypomagnesaemia, hypokalaemia, anuria/oliguria to undesirable effects" | Jul, 2024 |
| Interferon Beta-1b | Betaferon | 4.6. Fertility, pregnancy and lactation | Available data, which includes prospective observational studies, have not generally indicated a drug-associated risk of major birth defects with interferon beta-1b during pregnancy. Administration of Betaferon to monkeys during gestation resulted in increased embryo-fetal death at or above exposures greater than 3 times the human therapeutic dose | Jul, 2024 |
| Infliximab | Remicade | 4.8 Undesirable effects | Weight increased | July, 2024 |