Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Tizanidine | Sirdalud | 4.6. Fertility, pregnancy and lactation | In animal studies, administration of tizanidine during pregnancy resulted in developmental toxicity (embryofetal and postnatal offspring mortality and growth deficits) at doses less than those used clinically | Sep, 2024 |
| Olmesartan Medoxomil,Hydrochlorothiazide | Olmetec Plus | "4.4 Special Warnings and Special Precautions for Use. 4.8 Undesirable effects" | Autoimmune hepatitis | Sep, 2024 |
| Linezolid | Zyvox | "4.4 Special Warnings and Special Precautions for Use. 4.8 Undesirable effects" | Rhabdomyolysis | Sep, 2024 |
| Bimekizumab | Bimzelx | 4.8 Undesirable effects | Updates on frequency of oral candidiasis and dermatitis | Sep, 2024 |
| Ketorolac Tromethamine | Acuvail ophthalmic solution | "4.4 Special Warnings and Special Precautions for Use 4.6. Fertility, pregnancy and lactation 4.8 Undesirable effects" | "Multiple safety updates including; risk of Contamination and allergic reactions No evidence of teratogenicity has been observed in rats or rabbits with ACUVAIL at clinically relevant doses." | Sep, 2024 |
| Hepatitis B Virus HBSAG Surface Antigen | "Engerix-B10 Engerix-B20" | 4.8 Undesirable effects | Transverse myelitis | Sep, 2024 |