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Propylthiouracil

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Propylthiouracil

Warnings
Precautions

WARNINGS

Agranulocytosis is potentially the most serious side effect of propylthiouracil (propylthiouracil (propylthiouracil (propylthiouracil tablet) tablet) tablet) therapy. Patients should be instructed to report any symptoms of agranulocytosis, such as fever or sore throat. Leukopenia, thrombocytopenia, and aplastic anemia (pancytopenia) may also occur. The drug should be discontinued in the presence of agranulocytosis, aplastic anemia (pancytopenia), ANCA-positive vasculitis, hepatitis, interstitial pneumonitis, fever, or exfoliative dermatitis. The patient's bone marrow function should be monitored. Propylthiouracil (propylthiouracil (propylthiouracil (propylthiouracil tablet) tablet) tablet) can cause fetal harm when administered to a pregnant woman. Because the drug readily crosses placental membranes and can induce goiter and even cretinism in the developing fetus, it is important that a sufficient, but not excessive, dose be given. In many pregnant women, the thyroid dysfunction diminishes as the pregnancy proceeds; consequently a reduction of dosage may be possible. In some instances, propylthiouracil (propylthiouracil (propylthiouracil (propylthiouracil tablet) tablet) tablet) can be withdrawn 2 or 3 weeks before delivery.

If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be warned of the potential hazard to the fetus. Postpartum patients receiving propylthiouracil (propylthiouracil (propylthiouracil (propylthiouracil tablet) tablet) tablet) should not nurse their babies.

Rare reports exist of severe hepatic reactions including encephalopathy, fulminant hepatic necrosis, and death in patients receiving propylthiouracil (propylthiouracil (propylthiouracil (propylthiouracil tablet) tablet) tablet) . Symptoms suggestive of hepatic dysfunction (anorexia, pruritus, right upper quadrant pain, etc.) should prompt evaluation of liver function. Treatment with propylthiouracil (propylthiouracil (propylthiouracil (propylthiouracil tablet) tablet) tablet) should be discontinued promptly in the event of clinically significant evidence of liver abnormality, including hepatic transaminases in excess of 3 times the upper limit of normal.

PRECAUTIONS

General

Patients who receive propylthiouracil (propylthiouracil (propylthiouracil (propylthiouracil tablet) tablet) tablet) should be under close surveillance and should be impressed with the necessity of reporting immediately any evidence of illness, particularly sore throat, skin eruptions, fever, headache, or general malaise. In such cases, white blood cell and differential counts should be made to determine whether agranulocytosis has developed. Particular care should be exercised with patients who are receiving additional drugs known to cause agranulocytosis.

Laboratory Tests

Because propylthiouracil (propylthiouracil (propylthiouracil (propylthiouracil tablet) tablet) tablet) may cause hypoprothrombinemia and bleeding, prothrombin time should be monitored during therapy with the drug, especially before surgical procedures. Thyroid function tests should be monitored periodically during therapy. Once clinical evidence of hyperthyroidism has resolved, the finding of an elevated serum TSH indicates that a lower maintenance dose of propylthiouracil (propylthiouracil (propylthiouracil (propylthiouracil tablet) tablet) tablet) should be employed.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Laboratory animals treated with propylthiouracil (propylthiouracil (propylthiouracil (propylthiouracil tablet) tablet) tablet) for > 1 year have demonstrated thyroid hyperplasia and carcinoma formation1. Such animal findings are seen with continuous suppression of thyroid function by sufficient doses of a variety of antithyroid agents, as well as in dietary iodine deficiency, subtotal thyroidectomy, and implantation of autonomous thyrotropic hormone - secreting pituitary tumors. Pituitary adenomas have also been described.

Pregnancy

Pregnancy Category D. SEE WARNINGS.

Nursing Mothers

The drug appears in human milk and is contraindicated in nursing mothers. See CONTRAINDICATIONS and WARNINGS.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 6 have not been established. For pediatric patients 6 years and older, see DOSAGE & ADMINISTRATION.

REFERENCE

1. International Agency for Research on Cancer, IARC Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Man. 1974; 7:67-76.

Last reviewed on RxList: 1/25/2010
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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