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0358/DAF/10 E ffl: 22104/2010Data/Date:

HDe/From: f;llf l,Dept. : #WHt*ffi Department of Pharmaceutical Affairs

ffiffifflAss./Signat.: *m#ffiF Dr. Choi Peng Cheong - Department Chief

ffifrffilFax: (8s3)-28s24016

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€F&/Fax:I E: F5ftfilFftt,ffi*#2bropvlthiouracil*?EElF*fH-;flAss./Subject: Latest safety update on the antithyroid propylthiouracil.

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The United States Food and Drug Administration (USFDA) notified healthcare professionalsabout the added Boxed Waming on the label of pro'pylthiouracil (PTU), an antithlroid medication.Reports of severe liver injury and acute liver failure, some of which have been fatal, in adult andpediatric patients using this medication were included into this section. The new waming alsostates that for patients being started on treatment for hyperthl'roidism it may be appropriate toreserve use of propylthiouracil for those who cannot tolerate other treatments such as methimazole,radioactive iodine or surgery.

With the above information, USFDA reminded healthcare professionals to be aware of this newsafety information and adhere to the recommendation on the drug label. In congruence with theAgency's additional advice, the Department of Pharmaceutical Affairs, Health Bureau would liketo re-iterate the following information for our local physicians and pharmacists:o be aware that severe liver injury and acute liver failure, including fatal cases, that have been

reported in adult and pediatric patients taking PTU.o before initiating a patient on hyperthl'roid treatment, PTU should be reserved for patients

who carmot tolerate methimazole or for patients for whom radioactive iodine therapy orsurgery is not an appropriate heatment.

o PTU may be the treatment of choice when an antithyroid drug is needed during andjust priorto the first himester of pregnancy. Fetal abnormalities have been seen with methimazole useduring the flrst trimester of pregnancy.

o PTU is not recommended for use in pediatric patients, except in rare instances during whichother altemative heatments are inappropriate.

o review the updated information on the drug label and understand the complete informationon the use of PTU so that you can counsel the patients or care-takers when they are pickingup the prescription :i remind them to follow the direction ofuse as given.ii for female patients notifr them that PTU may be the treatment of choice during and

just before the first trimester of pregnancy (weeks 1-12). Consult with theirprescribing physician for advice if they are pregnant or have plan to become pregnantwhile on PTU or other antithwoid medicines.

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iii instruct them to contact their physician or pharmacist if they experience fever, loss ofappetite, nausea, vomiting, tiredness, itchiness, dark-colored urine, or yellowing ofyour skin or eyes while on PTU.

iv educate and familiarize the patients to notiffing their attending physician andpharmacist about any medication they are taking or the medical conditions they mayhave.

v notifi them NOT to stop taking PTU or any antithyroid medication without talkingwith their physician or pharmacist.

If physicians, pharmacists or other healthcare professionals suspect any kind of adverse reactionsubsequent to the use of propyhiouracil or any antithyoid medication, please report through anyof the following methods : .O Online - http://www.ssm.gov.mo/desigdwebservices/c_wservices_main.htmo Mail to - 51 Avenida do Sidonio Pais. Edificio ChinaPlaza,2nd Floor, Macao S.A.R., Chinao Faxto - 853-28524016

The report form can be collected in person at Department of Pharmaceutical Affairs ordownloaded from the website designated as http://www.ssm.gov.mo/design/services/serpt_chn.pdf.Should you have any query, please contact Ms. Beatrice Young or Mr. Jeffrey Lam at 8598-3517or 8598-3439 respectively from the Division of Pharmacovigilance and Pharmacoeconomicsduring office hours. In case of urgent situations during offhows, please page 85008068.

Thanking you in advance for your attention!

*+rrgtfr ffiffiFChief. Deoartment of Pharmaceutical Affairs

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*,rEf#Choi Peng Cheong

44ANlRefetenceandwebsitefordolrr]oadingthePTUMedicationGuide:http://www.fda.gov/Drugs/DrugSafety/PostrnarketDrugSafetylnformationforPatientsandProviders/ucm209023.htmhttp ://www.fda. gov/downloadslDrugs/DrugSafetyfu CM20853 3.pdf

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