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  1. www.ncbi.nlm.nih.gov › books › NBK549828Propylthiouracil (PTU) - StatPearls - NCBI Bookshelf

    Jun 5, 2023 · PTU has a black box warning for this issue. There are cases reported in pregnancy, adults, and children. Hence, caution is necessary with its use, especially in the first six months of the start of therapy.

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  3. www.fda.gov › drugs › postmarket-drug-safetyNew Boxed Warning on severe liver injury with propylthiouracil

    • Safety Announcement
    • Additional Information For Patients
    • Additional Information For Healthcare Professionals
    • Data Summary

    [04-21-2010] The United States Food and Drug Administration (FDA) has added a Boxed Warningto the label for propylthiouracil, a drug used to treat hyperthyroidism (overactive thyroid), to include information about reports of severe liver injury and acute liver failure, some of which have been fatal, in adult and pediatric patients using this medica...

    See full list on fda.gov

    Be aware that severe liver injury has occurred in patients taking propylthiouracil.
    Read the Medication Guide when picking up a prescription for propylthiouracil. It will help you understand the potential risks and benefits of this medication.
    Contact your healthcare professional if you have fever, loss of appetite, nausea, vomiting, tiredness, itchiness, dark colored urine, or yellowing of your skin or eyes while taking propylthiouracil.
    Propylthiouracil may be the treatment of choice during and just before the 1st trimester of pregnancy (weeks 1-12). Talk to your healthcare professional if you are pregnant (or plan to become pregn...

    See full list on fda.gov

    Be aware that severe liver injury and acute liver failure, including fatal cases, have been reported in adult and pediatric patients taking propylthiouracil.
    When initiating hyperthyroid treatment, propylthiouracil should be reserved for patients who cannot tolerate methimazole or for patients for whom radioactive iodine therapy or surgery is not approp...
    Propylthiouracil may be the treatment of choice when an antithyroid drug is needed during and just prior to the 1st trimester of pregnancy. Fetal abnormalities have been seen with methimazole use d...
    Propylthiouracil is not recommended for use in pediatric patients, except in rare instances in which other alternative treatments are not appropriate.

    See full list on fda.gov

    The new Boxed Warningand Risk Evaluation and Mitigation Strategy (REMS), are based on FDA's review of post-marketing safety reports of propylthiouracil, as well as meetings held with the American Thyroid Association, the National Institute of Child Health and Human Development, and the pediatric endocrine clinical community. Severe Liver Injury: FD...

    See full list on fda.gov

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  5. www.medscape.com › viewarticle › 720629FDA Adds Boxed Warning to Propylthiouracil - Medscape

    Apr 21, 2010 · April 21, 2010 — The US Food and Drug Administration (FDA) has added a boxed warning to the drug label for propylthiouracil about reports of severe liver injury and acute liver failure, in some...

  6. reference.medscape.com › drug › ptu-propylthiouracilPropylThyracil, PTU (propylthiouracil) dosing, indications ...

    Black Box Warnings. Severe liver injury and acute liver failure, some of which have been fatal, have been reported in adult and pediatric patients taking propylthiouracil

  7. www.drugs.com › sfx › propylthiouracil-side-effectsPropylthiouracil Side Effects: Common, Severe, Long Term

    Jun 7, 2024 · Some side effects of propylthiouracil may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

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  8. www.ncbi.nlm.nih.gov › pmc › articles63 Years and 715 Days to the “Boxed Warning”: Unmasking of ...

    Jul 12, 2010 · 715 days after potential problems related to PTU use in children were presented in a debate in front of the Lawson Wilkins Pediatric Endocrine Society (LWPES), the US Food and Drug Administration issued a black-box warning about the hepatotoxicity risk of the antithyroid drug propylthiouracil (PTU) .

  9. friedmanfellows.com › elibrary › 2014Propylthiouracil, and methimazole, and carbimazole-related ...

    Introduction: Propylthiouracil (PTU)hasbeenusedforthetreatmentofhyper-thyroidism since the 1940s, but over the years reports of significant hepato-toxicity have come forth, particularly in children. This led to a black box warning being issued by the US FDA in 2009, followed by a similar warning

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