Label Changes for:
Retrovir (zidovudine) Tablets, Capsules, and Syrup
September 2008
Changes have been made to the ADVERSE REACTIONS sections of the safety label.
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. |
Sections Modified
ADVERSE REACTIONS
- Clinical Trials Experience
- Adults
- 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%.
- Pediatrics
- 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
- Pregnancy
- Pediatric Use
NONCLINICAL TOXICOLOGY
- Carcinogenesis, Mutagenesis, Impairment of Fertility
- Reproductive and Developmental Toxicology Studies
