Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| 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 |
| Ceftaroline Fosamil | Zinforo | Zinforo | Kounis syndrome | Jul, 2024 |