Retrovir (zidovudine) Tablets, Capsules, and Syrup September 2008
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 2008
|The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.|
- Clinical Trials Experience
- In addition to the adverse reactions listed in Table 2, adverse reactions observed at an incidence of >5% in any treatment arm in clinical studies (NUCA3001, NUCA3002, NUCB3001, and NUCB3002)...
- ...hyperbilirubinemia was reported at an incidence of <0.8%.
- Macrocytosis was reported in the majority of pediatric patients receiving Retrovir 180 mg/m2 every 6 hours in open-label studies. Additionally, adverse reactions reported at an incidence of <6%...
USE IN SPECIFIC POPULATIONS
- Pediatric Use
- Carcinogenesis, Mutagenesis, Impairment of Fertility
- Reproductive and Developmental Toxicology Studies