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Patients who are taking PTU should not panic, however, as the overall risk of problems is quite small. The FDA's warning is based on the fact that since 1969, when the FDA's Adverse Events Reporting System database started tracking adverse events related to medications, there have been 34 cases of severe liver injury associated with PTU. Of the 23 adults affected, 13 deaths and 5 liver transplants were reported, and among the 11 children, 2 children died and 7 required liver transplantation. The PTU findings compare to 5 cases of severe liver injury -- and 3 deaths -- that have been reported with methimazole.
According to the FDA, however: "Although the number of identified reports of postmarketing cases of severe liver injury with propylthiouracil use between 1969 to 2009 is 34, FDA included information about this adverse event in the Boxed Warning due to the severity of the cases, some of which have been fatal, and to ensure that healthcare professionals are aware of this risk and are vigilant for the signs and symptoms of hepatic toxicity."
So, as you can see, given that hundreds of thousands of people take antithyroid drugs every year, the overall risk is quite small. But based on these findings and the medical literature, the FDA wants physicians to be aware that PTU is associated with a higher risk for clinically serious or fatal liver injury, compared with methimazole.
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