FDA Issues Safety Alert on Drug Used to Treat Overactive Thyroid Conditions
The U.S. Food and Drug Administration (FDA) has issued a safety alert for the antithyroid drug propylthiouracil (PTU), which is used to treat hyperthyroidism -- an overactive thyroid. According to the FDA notice posted June 3, 2009, the FDA has notified healthcare professionals of the risk of serious liver injury, including liver failure and death, with the use of propylthiouracil (PTU) in adults and children being treated with the drug. According to the FDA, based on reports to the FDA’s Adverse Event Reporting System -- known as AERS-- there appears to be an increased risk of liver toxicity with PTU, when compared to the other commonly-used antithyroid drug methimazole (also known by the brand name Tapazole). The FDA suggests that if patients are on PTU therapy, they need to be be monitored carefully for symptoms and signs of liver injury, especially during the first six months after starting therapy -- which is the timeframe during which there is the greatest risk of side effects.
The FDA identified 32 AERS cases (22 adults and 10 children) of serious liver injury associated with PTU use. Among the adults, there were 12 deaths and 5 liver transplants. Among the pediatric patients on PTU, 1 case resulted in death and 6 in liver transplants.
In comparison, methimazole had 5 AERS cases of serious liver injury identified -- all five were in adults, and 3 resulted in death.
Typically, PTU is considered a second choice to methimazole for antithyroid drug treatment, except if a patient is allergic to or intolerant of methimazole. (The exception is in pregnant women, because there is some concerns about birth defects, including aplasia cutis, in infants born to mothers using methimazole (and no similar cases for PTU. So some practitioners recommend PTU for pregnant women requiring antithyroid drug treatment.
In April of 2009, a letter was published in the New England Journal, warning that PTU can cause fatal liver failure in children, and should no longer be used to treat them.
Additional Information on PTU and Hyperthyroidism Treatment:
- Thyroid Drug PTU Linked to Deadly Liver Failure in Children -- April 9, 2009
- Treatment of Graves' Disease and Hyperthyroidism: A Look at Antithyroid Drugs...
- Graves' Hyperthyroidism Home Page/Information Center
- Treating Hyperthyroidism and Graves' Disease During Pregnancy
Source: FDA Drug Safety Information on PTU
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Comments
It is great that the FDA is warning patients about this medication. I was put on PTU and taken off 6wks later due to poor liver function. I am thankful that my endo. was as vigilant as she was and watching how my liver was reacting to the PTU. Unfortunately b/c we are TTC I wasn’t able to take the Tapazole as an alternative. Thyroid surgery for me.
I’m wondering why this drug was given to me back in 2005-2006 when I had Graves, if it is typically a second choice to the other one. It was a clinic doctor that I saw, I had never had any health problems before and I basically did what he said. He told me asking a lot of questions would stress me out more and that was how I got hyper in the first place.
I’m hypo now — thank goodness I’ve learned to become a better advocate for myself, and have an endo who listens to my concerns!
Dr. Kate seems great! Would she be able to refer any doctors as herself in the Portland area? I’m a bit frustrated with my present physician.
Thanks,
Carrie
propylthiouracil adverse events reported to the FDA can be viewed here:
the specific link below is for PTU adverse events where hepatic failure was reported.
http://www.fdable.com/aers/advanced_query/b1b035c58021
I was on PTU for seven years for Graves Disease. During the first year, I took nine pills a day. I now have stage IV colo/rectal cancer and have one small spot on my liver. PTU lowers your white blood cell count. During chemo treatments my neutrophils count was 0, so in December 2008 I had my thyroid removed. After six months my TSH is .425. I took PTU every eight hours of my life for seven years and I would not call it life threating. (It is bitter tasting.)