Drug Updates
Patient Teaching
Drug Warnings
News Capsules
Herbal Spotlight
Quik Tools
Drug Info
Links
Drug Info Bookstore
Feedback
Disclaimer
|
|
 propylthiouracil |
| Available in generic form only |
|
| |
Pharmaceutical
company:
Various manufacturers
|
NEW WARNING
The Food and Drug Administration (FDA) is warning health care professionals that propylthiouracil, a thyroid hormone antagonist, may increase the risk of serious liver injury, liver failure, and death. The warning is based on 32 cases of serious liver injury reported during propylthiouracil therapy. Of the affected adults, 12 patients died and 5 needed liver transplantation. Of the affected children, 1 patient died and 6 needed liver transplantation. In comparison, the agency received only 5 reports of liver injury among patients taking methimazole.
FDA officials say they're continuing to monitor reports of liver trouble during propylthiouracil therapy, and they're working on changes to the drug's prescribing information, label warnings, and treatment guidelines. In the meantime, they've made these recommendations:
- Consider propylthiouracil as second-line therapy for patients who are allergic to or intolerant of methimazole.
- Use propylthiouracil for patients in their first trimester of pregnancy because methimazole may have a higher risk of fetal harm.
- Monitor patients closely during propylthiouracil therapy, especially during the first 6 months.
- Stop propylthiouracil at any evidence of liver injury and provide supportive care.
- Don't use propylthiouracil in children unless the patient can't take methimazole and no other treatment options are available.
- Tell patients to promptly report evidence of liver impairment.
|
