Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Month |
|---|---|---|---|---|
| Lamotrigine | Lamictal | 4.4 Special Warnings and Special Precautions for Use | 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. | 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 |
| Live Varicella Vaccine | Varivax | 4.8 Undesirable effects | Syncope | Aug,2023 |
| Escitalopram Oxalate | Entapro | 4.8 Undesirable effects | Hyperprolactinaemia associated with Selective serotonin reuptake inhibitor (SSRIs)/ Serotonin and norepinephrine reuptake inhibitors (SNRIs) | Aug,2023 |