Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Enfortumab | Padcev | 4.4 Special warnings and precautions for use 4.8. Undesirable effects | Serious infections pneumonia Thrombocytopenia skin hyperpigmentation, skin discoloration, pigmentation disorder | Jan, 2026 |
| Clotrimazole | Canesten | 4.8. Undesirable effects | Anaphylactic reaction , Angioedema | Jan, 2026 |
| Ubrogepant | Ubrelvy | 4.6 Fertility, Pregnancy and Lactation | Lactation section updates | Jan, 2026 |
| Hydroxycarbamide | Xromi | 4.6. Fertility, pregnancy and lactation | The recommended duration of contraception in male and female patients following the end of treatment with hydroxycarbamide, should be 3 and 6 months, respectively | Jan, 2026 |
| Ceftriaxone | Samixon | 4.4 Special warnings and precautions for use 4.8. Undesirable effects | Hypersensitivity reactions Kounis syndrome | Jan, 2026 |
| Candesartan Cilexetil, Amlodipine Besilate | Unisia | 4.4 Special warnings and precautions for use 4.8. Undesirable effects | Intestinal angioedema | Jan, 2026 |