"The US Food and Drug Administration (FDA) is ordering stricter warnings and contraindications for the anemia drug ferumoxytol (Ferumoxytol, AMAG Pharmaceuticals), stating that even with current warnings, there have been 79 anaphylactic r"...
The following adverse reactions are described in detail in other labeling sections:
- Myelosuppression [see WARNINGS AND PRECAUTIONS]
- Malignancies [see WARNINGS AND PRECAUTIONS]
- Embryo-fetal toxicity [see BOXED WARNING and WARNINGS AND PRECAUTIONS]
- Vasculitic toxicities [see WARNINGS AND PRECAUTIONS]
- Risks with concomitant use of antiretroviral drugs [see WARNINGS AND PRECAUTIONS]
- Macrocytosis [see WARNINGS AND PRECAUTIONS]
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Clinical Trial Experience
In 299 patients treated for sickle cell anemia in the Multicenter Study of Hydroxyurea in Sickle Cell Anemia, the most common adverse reactions were hematologic, with neutropenia, and low reticulocyte and platelet levels necessitating temporary cessation in almost all patients. Hematologic recovery usually occurred in two weeks.
Other adverse reactions include hair loss, macrocytosis, bleeding, and melanonychia.
The following adverse reactions have been identified during postapproval use of hydroxyurea in the treatment of neoplastic diseases. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.
- Gastrointestinal disorders: stomatitis, anorexia, nausea, vomiting, diarrhea, and constipation
- Skin and subcutaneous tissue disorders: maculopapular rash, skin ulceration, dermatomyositis-like skin changes, peripheral and facial erythema, hyperpigmentation, atrophy of skin and nails, scaling, violet papules, and alopecia
- Renal and urinary disorders: dysuria, elevations in serum uric acid, blood urea nitrogen (BUN), and creatinine levels
- Nervous system disorders: headache, dizziness, drowsiness, disorientation, hallucinations, and convulsions
- General disorders: fever, chills, malaise, edema, and asthenia
- Hepatobiliary disorders: elevation of hepatic enzymes
- Respiratory disorders: diffuse pulmonary infiltrates, dyspnea, and pulmonary fibrosis
Read the Droxia (hydroxyurea capsules) Side Effects Center for a complete guide to possible side effects
Increased Toxicity With Concomitant Use Of Antiretroviral Drugs
In patients with HIV infection during therapy with hydroxyurea and didanosine, with or without stavudine, fatal and nonfatal pancreatitis have occurred. Hydroxyurea is not indicated for the treatment of HIV infection; however, if patients with HIV infection are treated with hydroxyurea, and in particular, in combination with didanosine and/or stavudine, close monitoring for signs and symptoms of pancreatitis is recommended. Permanently discontinue therapy with hydroxyurea in patients who develop signs and symptoms of pancreatitis.
Hepatotoxicity and hepatic failure resulting in death have been reported during postmarketing surveillance in patients with HIV infection treated with hydroxyurea and other antiretroviral drugs. Fatal hepatic events were reported most often in patients treated with the combination of hydroxyurea, didanosine, and stavudine. Avoid this combination.
Peripheral neuropathy, which was severe in some cases, has been reported in patients with HIV infection receiving hydroxyurea in combination with antiretroviral drugs, including didanosine, with or without stavudine.
Interference with Uric Acid, Urea, or Lactic Acid Assays
Studies have shown that there is an analytical interference of hydroxyurea with the enzymes (urease, uricase, and lactate dehydrogenase) used in the determination of urea, uric acid, and lactic acid, rendering falsely elevated results of these in patients treated with hydroxyurea.
Last reviewed on RxList: 8/6/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Droxia Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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