Flutamide Recall
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Questions & Answers
Side Effects & Adverse Reactions
Hepatic Injury
SEE WARNINGS SECTION.
Use in Women
Flutamide Capsules are for use only in men. This product has no indication for women, and should not be used in this population, particularly for nonserious or nonlife-threatening conditions.
Fetal Toxicity
Flutamide may cause fetal harm when administered to a pregnant woman (see Pregnancy).
Aniline Toxicity
One metabolite of flutamide is 4-nitro-3-fluoro-methylaniline. Several toxicities consistent with aniline exposure, including methemoglobinemia, hemolytic anemia, and cholestatic jaundice have been observed in both animals and humans after flutamide administration. In patients susceptible to aniline toxicity (e.g., persons with glucose-6-phosphate dehydrogenase deficiency, hemoglobin M disease, and smokers), monitoring of methemoglobin levels should be considered.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Flutamide Capsules are indicated for use in combination with LHRH-agonists for the management of locally confined Stage B2-C and Stage D2 metastatic carcinoma of the prostate.
Stage B2-C Prostatic Carcinoma
Treatment with Flutamide Capsules and the goserelin acetate implant should start 8 weeks prior to initiating radiation therapy and continue during radiation therapy.
Stage D2 Metastatic Carcinoma
To achieve benefit from treatment, Flutamide Capsules should be initiated with the LHRH- agonist and continued until progression.
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
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