Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Tixagevimab co-packaged with cilgavimab | Evusheld | 12.4 Microbiology section | The risk of prophylaxis failure due to antiviral resistance, including neutralization data on SARS-CoV-2 Omicron subvariants | Apr,2023 |
| Vandetanib | Caprelsa | 4.4 Special Warnings and Special Precautions for Use , 4.8 Undesirable effects | Toxic epidermal necrolysis, Photosensitivity reactions , Stevens-Johnson syndrome/Toxic epidermal necrolysis, erythema multiforme | Feb,2023 |
| Revefenacin | Yupelri | 4.8 Undesirable effects | Dry mouth | Apr,2023 |
| Esomeprazole | Nexium | 4.8 Undesirable effects | Impotence | Mar,2023 |
| Methotrexate | Mizotra | 4.6 Fertility, pregnancy and lactation | Contraception in males and females | Mar,2023 |
| Pemetrexed | Pemitax | 4.6 Fertility, pregnancy and lactation | Contraception in males and females | Mar,2023 |