Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Zocor | Simvastatin | 4.4 Special warnings and precautions for use, 4.8 Undesirable effect | Myasthenia gravis and ocular myasthenia/ lichenoid drug eruptions, gynecomastia | Apr, 2025 |
| Doravirine,Lamivudine,Tenofovir Disoproxil | Delstrigo | "4.4 Special warnings and precautions for use, 4.8 Undesirable effects, 4.6 Fertility, pregnancy and lactation" | =Severe cutaneous adverse reactions (SCARs) The potential risks of breastfeeding include: (1) HIV-1 transmission | Apr, 2025 |
| Ustekinumab | Stelara | 4.8 Undesirable effect | Crohn’s disease or ulcerative colitis were exposed for at least 4 years while 1,148 patients with psoriasis or Crohn’s disease were exposed for at least 5 years. | Apr, 2025 |
| Efmoroctocog Alfa | Elocta | 4.6 Fertility, pregnancy and lactation | Remove Pregnancy Category C | Apr, 2025 |
| Dopamine Hydrochloride | Dopamine | "4.4 Special warnings and precautions for use, 4.8 Undesirable effect" | Tissue Ischemia,Cardiac Arrhythmias, Hypotension after Abrupt Discontinuation | Apr, 2025 |
| Paclitaxel | Abraxane | 4.6 Fertility, pregnancy and lactation | Use effective contraception for female and male patients with female partners of reproductive potential | Apr, 2025 |