Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Perindopril Arginine,Indapamide,Amlodipine Besilate | Triplixam | "4.4 Special Warnings and Special Precautions for Use 4.8 Undesirable effects" | "Hypokalaemia found in association with low serum magnesium concentration can be refractory to treatment unless serum magnesium is corrected. Addition of hypochloraemia, hypomagnesaemia, hypokalaemia, anuria/oliguria to undesirable effects" | Jul, 2024 |
| Interferon Beta-1b | Betaferon | 4.6. Fertility, pregnancy and lactation | Available data, which includes prospective observational studies, have not generally indicated a drug-associated risk of major birth defects with interferon beta-1b during pregnancy. Administration of Betaferon to monkeys during gestation resulted in increased embryo-fetal death at or above exposures greater than 3 times the human therapeutic dose | Jul, 2024 |
| Infliximab | Remicade | 4.8 Undesirable effects | Weight increased | July, 2024 |
| Spironolactone | Aldactone | 4.6. Fertility, pregnancy and lactation | "There are limited data from the use of spironolactone in pregnant women. Studies in animals have shown reproductive toxicity associated with the anti-androgenic effect of spironolactone" | Jul, 2024 |
| Tacrolimus | Prograf | 4.8. Undesirable effects | Nephrotoxicity, febrile neutropenia, posterior reversible encephalopathy syndrome | Jun, 2024 |
| Azacitidine | Vidaza | 4.8. Undesirable effects | Cutaneous vasculitis | Jun, 2024 |