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Jun 5, 2023 · Acute liver injury: Reported cases have shown PTU to be associated with acute liver failure and death. PTU has a black box warning for this issue. There are cases reported in pregnancy, adults, and children.
- Fnu Amisha, Anis Rehman
- 2023/06/05
- 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...
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...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.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...
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) .
- Scott A Rivkees
- 2010
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
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.
Mar 1, 2020 · A boxed warning, also known as a “black label warning” or “black box warning,” is named for the black border surrounding the text of the warning that appears on the package insert, label, and other literature describing the medication (for example, magazine advertising). When the FDA Requires One.
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Does PTU have a black box warning?
Can PTU cause liver failure?
What is a boxed or black box warning?
What is a boxed warning?
Jul 4, 2023 · A boxed or black box warning is a serious warning given by the FDA for drugs or drug classes that may cause serious harm or death. Learn more about these warnings here.
