Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Valganciclovir | Valgan | "4.2 Posology and method of administration 6.6 Special precautions for disposal and other handling" | "SFDA requested SPC/ PIL update to all registered hazardous medications to add the proposed language regarding safe handling and disposal of hazardous medications in order to ensure safety of patients, healthcare professionals, and family caregivers. " | Jul, 2024 |
| Faricimab | Vabysmo | "4.4 Special Warnings and Special Precautions for Use 4.8 Undesirable effects" | Multiple safety updates including; retinal Vasculitis and/or Retinal Vascular Occlusion | Jul, 2024 |
| Apalutamide | Erleada | "4.4 Special Warnings and Special Precautions for Use 4.8 Undesirable effects" | Multiple safety updates including; Interstitial Lung Disease and restless legs syndrome | Jul, 2024 |
| Paliperidone | Invega | 4.8 Undesirable effects | Multiple safety updates including; Hyponatremia | Jul, 2024 |
| Rimegepant | Nurtec | "4.4 Special Warnings and Special Precautions for Use 4.5. Interactions with other medicinal products 4.6. Fertility, pregnancy and lactation 4.8 Undesirable effects" | "Multiple safety updates including; Medication overuse headache, nausea, dyspnoea Recommendations against use in patients with severe hepatic impairment, end-stage renal disease (CLcr < 15 ml/min), or concomitant use with strong or moderate inducers of CYP3A4 enzyme Interactions with CYP3A4 inhibitors/ inducers and P-gp and BCRP only inhibitors Animal studies did not demonstrate teratogenic potential and were only observed at at exposure levels associated with maternal toxicity (approximately 200 times greater than clinical exposures)" | Jul, 2024 |
| Medroxyprogesterone Acetate | Provera | 4.8 Undesirable effects | Meningiomas | Jul, 2024 |