Drug Safety-related Labeling Changes (SrLC)

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PROPYLTHIOURACIL (NDA-006188)

(PROPYLTHIOURACIL)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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09/19/2018 (SUPPL-26)

Approved Drug Label (PDF)

5 Warnings and Precautions

(Additions and/or revisions are underlined)

WARNINGS

Vasculitis

Cases of vasculitis resulting in severe complications and death have been reported in patients receiving propylthiouracil therapy. The cases of vasculitis include: glomerulonephritis, leukocytoclastic cutaneous vasculitis, alveolar/pulmonary hemorrhage, cerebral angiitis, and ischemic colitis. Most cases were associated with anti-neutrophilic cytoplasmic antibodies (ANCA)-positive vasculitis. In some cases, vasculitis resolved/improved with drug discontinuation; however, more severe cases required treatment with additional measures including corticosteroids, immunosuppressant therapy, and plasmapheresis. If vasculitis is suspected, discontinue therapy and initiate appropriate intervention.

PRECAUTIONS

Information for Patients

Inform patients that cases of vasculitis resulting in severe complications and death have occurred with propylthiouracil. Inform patients to promptly report symptoms that may be associated with vasculitis including new rash, hematuria or decreased urine output, dyspnea or hemoptysis.

6 Adverse Reactions

(Additions and/or revisions are underlined)

There are reports of a vasculitis associated with the presence of anti-neutrophilic cytoplasmic antibodies (ANCA), resulting in severe complications and death.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

MEDICATION GUIDE PROPYLTHIOURACIL (Pro-pil-thi-o-ur-a-sil) Tablets

(Extensive changes; please refer to labeling)

01/15/2016 (SUPPL-25)

Approved Drug Label (PDF)

Boxed Warning

WARNING

  • Severe liver injury and acute liver failure, in some cases fatal, have been reported in patients treated with propylthiouracil. These reports of hepatic reactions include cases requiring liver transplantation in adult and pediatric patients.
  • Propylthiouracil should be reserved for patients who cannot tolerate methimazole and in whom radioactive iodine therapy or surgery are not appropriate treatments for the management of hyperthyroidism.
  • Propylthiouracil may be the treatment of choice when an antithyroid drug is indicated during or just prior to the first trimester of pregnancy.


5 Warnings and Precautions

Liver Toxicity

  • *section updated
Use in Pregnancy

  • *section added

8 Use in Specific Populations

PLLR Conversion; please refer to label.

Questions related to the drug data in these files should be directed to the Center for Drug Evaluation and Research, Division of Drug Information
druginfo@fda.hhs.gov.

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