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Propylthiouracil-Boxed Warning Added
Audience: Endocrine healthcare professionals, Pharmacists, Pediatricians
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.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Online: www.fda.gov/MedWatch/report.htm
- Phone: 1-800-332-1088
- Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch "Download Forms" page, to address on the pre-addressed form
- Fax: 1-800-FDA-0178
Read the complete MedWatch 2010 Safety summary, including a link to the FDA Drug Safety Communication, at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
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