Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Lansoprazole | Takepron | 4.4 Special Warnings and Special Precautions for Use 4.8 Undesirable effects | Stevens-Johnson syndrome , toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms and acute generalized exanthematous pustulosis | Mar,2023 |
| Colistimethate Sodium | Colistin | 4.4 Special Warnings and Special Precautions for Use 4.8 Undesirable effects | Pseudo-Bartter syndrome | Mar,2023 |
| Bosutinib | Bosulif | 4.8 Undesirable effects | Interstitial lung disease | Mar,2023 |
| Furosemide | Lasix | 4.4 Special Warnings and Special Precautions for Use | Hearing loss in neonates, including premature neonates. | Mar,2023 |
| Cefixime | Suprax | "4.4. Special warnings and precautions for use 4.8 Undesirable effects" | "Antibiotic-associated colitis Urticaria, Rash, Pruritus, Acute generalised exanthematous pustulosis(AGEP) , General disorders and administrative site conditions: Drug Fever, Arthralgia" | Feb,2024 |
| Femara | Letrozole | 4.4 Special Warnings and Special Precautions for Use 4.8 Undesirable effects | Tendon disorders, specifically, tendonitis, tenosynovitis and tendon rupture | Mar,2023 |