Drug Notebook

FDA Alerts

    Toxicity
  • Highly toxic drug with a low therapeutic index.
  • Possible severe, sometimes life-threatening or fatal, adverse effects.
    Limit to Qualified Personnel
  • Administer only under supervision of qualified clinicians experienced in use of cytotoxic therapy. (See Adequate Patient Evaluation and Monitoring under Cautions.)
    Carcinogenicity
  • Hydroxyurea is genotoxic and is a presumed human carcinogen; also, mutagenic and clastogenic in vitro.
  • Secondary leukemias have been reported in patients receiving long-term therapy for myeloproliferative disorders (e.g., polycythemia vera, thrombocythemia).
  • Carefully consider risks of developing secondary malignancies against the benefits of therapy. (See Carcinogenicity under Cautions.)

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What is the most important information I should know about hydroxyurea?

Hydroxyurea can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested. It is important that you not miss any scheduled visits to your doctor.

Do not use this medication if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. Talk with your doctor if you have trouble swallowing the capsule. Your doctor may instruct you to open the capsule, pour the medicine powder into a glass of water, and drink this mixture. If you open a capsule, do not inhale the powder or let it come in contact with your skin. Wash your hands before and after handling the pills, and wear disposable gloves when opening the capsule. If any of the medicine is spilled, wipe up the spill with a damp cloth and throw the cloth away in a sealed plastic bag. Keep all medicine and empty capsule shells out of the reach of children and pets. Handle the tablets and capsules with extreme care. The medicine from a crushed or broken tablet or capsule can be dangerous if it gets in your eyes, mouth, or nose, or on your skin. Wash your hands before and after handling the pills or the medicine bottle. For best protection, wear disposable gloves whenever handling the bottle or the pills. Ask your doctor or pharmacist how to safely dispose of any unused tablets or capsules.

Call your doctor promptly if you have any skin changes such as pinpoint red spots, red patches, skin ulcers, or darkened skin (especially on your legs or feet). These may be early signs of a serious side effect.

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