Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| 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 | 4.4 Special Warnings and Special Precautions for Use. 4.8 Undesirable effects | Kounis syndrome | Jul, 2024 |
| Iodixanol | Visipaque | "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; disturbances in thyroid function and encephalopathy The use of beta blockers lowers the threshold for and increases the severity of contrast reactions and reduces the responsiveness of treatment of anaphylactoid reactions with adrenaline. Asthmatic patients are at higher risk on concomitant beta blockers experimental animal studies do not indicate direct or indirect harmful effects with respect to reproduction" | Jul, 2024 |
| Choriogonadotropin Alfa | Ovitrelle | "4.4 Special Warnings and Special Precautions for Use 4.6. Fertility, pregnancy and lactation 4.8 Undesirable effects" | "Multiple safety updates including; reproductive system neoplasms, and abdominal distension Data on a limited number ofexposed pregnancies indicate no increased risks ofmalformation orfoeto/neonatal toxicity " | Jul, 2024 |
| Exemestane | Aromasin | "4.2 Posology and method of administration 4.8 Undesirable effects 6.6 Special precautions for disposal and other handling" | "Multiple safety updates including; elevated hepatic enzymes, elevated bilirubin, and Hyperhidrosis 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 |