Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Femara | Letrozole | 4.4 Special Warnings and Special Precautions for Use 4.8 Undesirable effects | Tendon disorders, specifically, tendonitis, tenosynovitis and tendon rupture | Mar,2023 |
| Cephalexin | Keflex | 4.4 Special Warnings and Special Precautions for Use | Seizures | Mar,2023 |
| Telmisartan | Micardis | 4.8. Undesirable Effects | Hyponatremia | Dec,2022 |
| Mercaptopurine | Purinethol | 4.8. Undesirable effects | Erythema nodosum | Dec,2022 |
| Upadacitinib | Rinvoq | 4.4. Special warnings and precautions for use 4.8. Undesirable effects | Serious hyper sensitivity reactions such as anaphylaxis and angioedema have been reported in patients receiving upadacitinib. If a clinically significant hypersensitivity reaction occurs, discontinue upadacitinib and institute appropriate therapy. Serious hypersensitivity reactions | Dec,2022 |
| Itraconazole | Sporanox | 4.4 Special warnings and precautions for use | Coadministration of specific drugs with itraconazole may result in changes in efficacy of itraconazole and/or the coadministered drug, life -threatening effects and/or sudden death. | Dec,2022 |