Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Amikacin | Miacin | 4.4 Special Warnings and Special Precautions for Use | Updated Neuro/Ototoxicity section to include genetic mutations | Mar,2023 |
| Cabazitaxel | Jevtana | 4.8 Undesirable effects | Nail disorder, gastrointestinal haemorrhage, ileus, gastritis, colitis, and gastrointestinal perforation | Mar,2023 |
| Onasemnogene Abeparvovec | Zolgensma | 4.4 Special Warnings and Special Precautions for Use , 4.8 Undesirable effects | Addition of baseline laboratory testing/ Hepatotoxicity , Transient decrease in platelet count to levels, liver failure with fatal outcome | Mar,2023 |
| Venlafaxine Hydrochloride | Efexor Xr | 4.4 Special Warnings and Special Precautions for Use 4.5. Interactions with other medicinal products | Suicide/Suicidal Thoughts , Interactions with alcohol | Mar,2023 |
| Caplacizumab | Cablivi | 4.4 Special Warnings and Special Precautions for Use 4.5. Interactions with other medicinal products | Bleeding , No interaction studies evaluating use of caplacizumab with anticoagulants, antiplatelets, and thrombolytics | Mar,2023 |
| Clofarabine | Allbloc | 4.6 Fertility, pregnancy and lactation | Contraception in males and females | Mar,2023 |