藥物警訊

Daytrana Patch (methylphenidate transdermal system): Drug Safety Communication - Permanent Skin Color Changes

AUDIENCE: Dermatology, Psychiatry, Pharmacy

ISSUE: FDA is warning that permanent loss of skin color may occur with use of the Daytrana patch (methylphenidate transdermal system) for Attention Deficit Hyperactivity Disorder (ADHD). FDA added a new warning to the drug label to describe this skin condition, which is known as chemical leukoderma. Chemical leukoderma is a skin condition that causes the skin to lose color due to repeated exposure to specific chemical compounds. The condition is not physically harmful, but it is disfiguring. The areas of skin color loss described with the Daytrana patch ranged up to 8 inches in diameter. This condition is not thought to be reversible, which may cause emotional distress.

BACKGROUND: The Daytrana patch treats ADHD by working to increase attention and decrease restlessness in children and adolescents who are overactive, cannot concentrate for very long, or are easily distracted and impulsive.

RECOMMENDATION: Patients or their caregivers should watch for new areas of lighter skin, especially under the drug patch, and immediately report these changes to their health care professionals. Patients should not stop using the Daytrana patch without first talking to their health care professionals. FDA recommends that health care professionals consider alternative treatments for patients who experience these skin color changes.

Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:
http://www.fda.gov/Drugs/DrugSafety/ucm452244.htm?source=govdelivery&utm...

FDA發布藥物安全警訊，使用治療注意力不足過動症之藥品Daytrana (methylphenidate)經皮貼片可能出現永久的皮膚褪色現象，稱為化學性白斑。FDA於藥品仿單中新增相關警語。化學性白斑為因反覆暴露在特殊的化學成份之下導致皮膚顏色消失之狀況，此症狀無害但影響美觀。使用此藥造成之色素消失範圍最大可至直徑8英吋，無法恢復，可能引起困擾。

Daytrana貼片為治療注意力不足過動症之藥品，藉由增加過動且無法長期集中注意力之病人的專注力以及降低燥動現象。FDA建議病人或其照顧者應留意皮膚尤其是貼片接觸的部位是否有新的白斑出現，並應立即告知醫療人員，病人不應在未與醫療人員討論之情況下自行停止使用。醫療人員若發現病人出現皮膚顏色改變現象，應考慮改以其他替代用藥治療。

相關訊息與連結請參考FDA網址：

http://www.fda.gov/Drugs/DrugSafety/ucm452244.htm?source=govdelivery&utm...

資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部