FDA Warning on Propylthiouracil

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http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm210794.htm

Warning on Propylthiouracil

FDA has added a boxed warning to the label for propylthiouracil to include

information about reports of severe liver injury and liver failure, including

some deaths, in adults and children using this medication. Propylthiouracil is a

drug used to treat overactive thyroid (hyperthyroidism).

Recommendations:

Tell your health care professional about any medication you are taking or

medical conditions you may have before taking propylthiouracil.

Read the Medication Guide that comes with each prescription for propylthiouracil

to better understand the potential risks and benefits of your medication.

Contact your health care professional if you have fever, loss of appetite,

nausea, vomiting, tiredness, itchiness, dark colored urine, or yellowing of your

skin or eyes while taking propylthiouracil.

Propylthiouracil may be the treatment of choice during and just before the first

trimester of pregnancy (weeks 1–12). Talk to your health care professional if

you are pregnant, or plan to become pregnant, and are taking a medication to

treat hyperthyroidism.

Don’t stop taking propylthiouracil unless told to do so by your health care

professional.

For more information, see FDA’s Drug Safety Communication on propylthiouracil8.:

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsan\

dProviders/ucm209023.htm