Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
---|---|---|---|---|
Carfilzomib | Kyprolis | "4.4 Special Warnings and Special Precautions for Use 4.8 Undesirable effects" | Multiple safety updates including; ventricular tachycardia and Hepatitis B Virus (HBV) Reactivation | Aug, 2024 |
Clindamycin Hydrochloride | Dalacin C | "4.4 Special Warnings and Special Precautions for Use 4.8 Undesirable effects" | Esophagitis and esophageal ulceration | Aug, 2024 |
Ethinylestradiol,Levonorgestrel | Logynon | 4.8 Undesirable effects | Exacerbation of the symptoms of hereditary and acquired angioedema | Aug, 2024 |
Neratinib | Nerlynx | 4.8 Undesirable effects | Syncope | Aug, 2024 |
Ceftazidime,Avibactam | Zavicefta | "4.4 Special Warnings and Special Precautions for Use 4.8 Undesirable effects" | Kounis syndrome | Aug, 2024 |
Rupatadine Fumarate | Pafinur | "4.5. Interactions with other medicinal products 4.8 Undesirable effects" | "Interaction with midazolam hypersensitivity reactions (including anaphylactic reactions, angioedema and urticarial)" | Aug, 2024 |