Safety Alerts & Recalls
What does this mean?
The recommendations in the Boxed Warning and the requirement of a Medication Guide are based on the FDA's review of post-marketing safety reports of propylthiouracil well as meetings with the American Thyroid Association, the National Institute of Child Health and Human Development, and the pediatric endocrine clinical community.
If you take propylthiouracil, please review the following:
1) Be aware that severe liver injury has occurred in patients taking propylthiouracil.
2) Read the Medication Guide when picking up a prescription for propylthiouracil. It will help you understand the potential risks and benefits of this medication.
3) Contact your healthcare professional right away if you have fever, loss of appetite, nausea, vomiting, tiredness, itchiness, dark colored urine, or yellowing of your skin or eyes while taking propylthiouracil. These are early signs of liver injury.
4) Talk to your healthcare professional if you are pregnant (or plan to become pregnant) and are taking a medication to treat hyperthyroidism. Propylthiouracil may be the treatment of choice during and just before the 1st trimester of pregnancy (weeks 1-12).
5) Do not stop taking propylthiouracil unless told to do so by your healthcare professional.
6) If you have any questions or concerns about propylthiouracil, please follow up with your doctor or other healthcare professional.
Propylthiouracil: FDA Requires Addition of Boxed Warning About Reports of Severe Liver Injury
The Food and Drug Administration (FDA) has added a Boxed Warning to the label for propylthiouracil 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 medication. In general, propylthiouracil is considered second-line drug therapy for hyperthyroidism, a condition of overactive thyroid. The new warning also describes appropriate uses of propylthiouracil, including during and just before the first trimester of pregnancy, and for those who cannot tolerate other hyperthyroidism treatments such as methimazole, radioactive iodine, or surgery.
Propylthiouracil has been shown to be effective in reducing thyroid hormone levels and decreasing symptoms associated with hyperthyroidism. However, to help patients understand the known benefits and potential risks of this medication, the FDA is also requiring that a Medication Guide be given to every patient filling a prescription for propylthiouracil.
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