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About the FDA Approved Listings

Drugs Approved by the FDA

Drug Name: Ethyol (amifostine)

The following information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Alza, U.S. Bioscience
Approval Status: Approved December 8, 1995
Treatment for: ovarian cancer

General Information

Ethyol has been approved to reduce the renal toxicity associated with repeated administration of chemotherapy in subjects with advanced ovarian cancer. Currently, there are only limited data on the effects of Ethyol on the efficacy of chemotherapy in other settings. Ethyol should not be administered to patients receiving chemotherapy for malignancies that are commonly curable, except in the context of a clinical study.

Clinical Results

Pretreatment with Ethyol significantly reduced the cumulative renal toxicity associated with multiple cycles of chemotherapy.

Side Effects

The most common adverse effects of Ethyol were vomiting, low blood pressure, somnolence, and sneezing. Vomiting, hypotension, and somnolence were more common with higher drug doses. In a phase I trial, vomiting and somnolence were experienced significantly more frequently by women than men.

Literature References

Spencer, C. and Goa, Karen. Amifostine: A Review of its Pharmacodynamic and Pharmacokinetic Properties, and Therapeutic Potential as a Radioprotector and Cytoxic Chemoprotector. Drugs 50(6): 1001-1031, 1995.


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Drug listing last updated on June 20, 2008

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