Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Linezolid | Zyvox | "4.4 Special Warnings and Special Precautions for Use. 4.8 Undesirable effects" | Rhabdomyolysis | Sep, 2024 |
| Bimekizumab | Bimzelx | 4.8 Undesirable effects | Updates on frequency of oral candidiasis and dermatitis | Sep, 2024 |
| Ketorolac Tromethamine | Acuvail ophthalmic solution | "4.4 Special Warnings and Special Precautions for Use 4.6. Fertility, pregnancy and lactation 4.8 Undesirable effects" | "Multiple safety updates including; risk of Contamination and allergic reactions No evidence of teratogenicity has been observed in rats or rabbits with ACUVAIL at clinically relevant doses." | Sep, 2024 |
| Hepatitis B Virus HBSAG Surface Antigen | "Engerix-B10 Engerix-B20" | 4.8 Undesirable effects | Transverse myelitis | Sep, 2024 |
| Eftrenonacog Alfa | Alprolix | 4.8 Undesirable effects | Anaphylactic shock | Sep, 2024 |
| Human Immunoglobulin G | Pentaglobin | "4.3 Contraindications 4.4 Special Warnings and Special Precautions for Use 4.5. Interactions with other medicinal products 4.6. Fertility, pregnancy and lactation 4.8 Undesirable effects" | "Contraindicated use in patients with selective IgA deficiency Multiple saffety updates including; neutropenia, leukopenia, and transfusion related acute lung injury Interactions with loop diuretics Updated safety information in breastfeeding women" | Sep, 2024 |