Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Isatuximab | Sarclisa | 4.4 Special warnings and precautions for use | Serious infusion reactions including severe anaphylactic reactions | May,2023 |
| Lamotrigine | Lamictal | 4.4 Special Warnings and Special Precautions for Use 4.8 Undesirable effects | Human leukocyte antigen B (HLA-B*1502) allele in Asian has been shown to be associated with the risk of developing Stevens-Johnson syndrome/Toxic epidermal necrolysi when treated with lamotrigine., Motor and/or phonic tics,Pseudolymphoma | Sep,2023 |
| Flurbiprofen | Froben | 4.4 Special Warnings and Special Precautions for Use | Warning of masking of symptoms of underlying infections | Sep,2023 |
| Tobramycin | Tofibra | 4.4 Special Warnings and Special Precautions for Use | Increased risk of aminoglycoside-associated ototoxicity in patients with mitochondrial mutations | Sep,2023 |
| Amikacin | Miacin | 4.4 Special Warnings and Special Precautions for Use | Increased risk of aminoglycoside-associated ototoxicity in patients with mitochondrial mutations | Sep,2023 |
| Macitentan | Opsumit | 4.8 Undesirable effects | Risk of flushing | May,2023 |