藥物警訊（藥師週刊 第1723期）

Unapproved Cough, Cold, Allergy Products: FDA Prompts Removal From Market  

AUDIENCE: Consumer, Family Practice, Pharmacy

FDA announced that it intends to remove certain unapproved prescription cough, cold, and allergy drug products from the U.S. market. Unapproved prescription cough, cold, and allergy drug products have not been evaluated by the FDA for safety, effectiveness, and quality. People may be at greater risk when using these products than when using FDA-approved prescription drugs or drugs that are appropriately marketed over-the-counter (OTC).

Many health care providers are unaware of the unapproved status of drugs and have continued to unknowingly prescribe them because the drugs’ labels do not disclose that they lack FDA approval.

BACKGROUND: Cough, cold, and allergy drug products are used to relieve symptoms associated with the common cold or upper respiratory allergies. These symptoms may include coughing, chest congestion, nasal congestion, itchy eyes, and sneezing. Some cough, cold, and allergy products may be purchased over the counter (OTC), while others require a prescription.? See link below for a list of the unapproved prescription cough, cold, and allergy drug products FDA intends to remove from the market.

RECOMMENDATION: Consumers who believe they are taking an unapproved prescription cough, cold, or allergy product should contact their health care provider to discuss alternatives.

Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

* Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
* Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including links to the News Release, Q&As, and List of Unapproved Prescription Cough, Cold, and Allergy Products at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

FDA宣佈要將一些未經許可的咳嗽、感冒及過敏藥從美國下市，這些未經許可的咳嗽、感冒及過敏藥未曾經由FDA評估安全性、有效性及品質，民眾在使用這些藥品時，比起使用FDA許可的處方藥或適宜的非處方藥，要冒著更大的風險。因這些藥品未標示未經FDA許可，許多醫療專業人員在不知道此藥未經許可的情況下，持續地用這些藥品開處方。

咳嗽、感冒及過敏藥是用來緩解一般感冒或上呼吸道過敏引起的症狀，這些症狀可能包括咳嗽、胸悶、鼻塞、眼睛癢及流鼻水。有些咳嗽、感冒及過敏藥可以不需醫師處方而購買，有些則需醫師處方。即將下市的咳嗽、感冒及過敏藥品品項請參照FDA網站。

相關訊息與連結請參考FDA網址：http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm245279.htm
[Posted 03/02/2011]

Topamax (topiramate): Label Change - Risk For Development of Cleft Lip and/or Cleft Palate in Newborns

Available as generic topiramate

AUDIENCE: Neurology, OB/GYN

FDA notified healthcare professionals and patients of an increased risk of development of cleft lip and/or cleft palate (oral clefts) in infants born to women treated with Topamax (topiramate) during pregnancy. Because of new human data that show an increased risk for oral clefts, topiramate is being placed in Pregnancy Category D. Pregnancy Category D means there is positive evidence of human fetal risk based on human data but the potential benefits from use of the drug in pregnant women may be acceptable in certain situations despite its risks. The patient medication guide and prescribing information for Topamax and generic topiramate will be updated with the new information.

BACKGROUND: Topiramate is an anticonvulsant medication approved for use alone or with other medications to treat patients with epilepsy who have certain types of seizures. Topiramate is also approved for use to prevent migraine headaches. The new data was from the North American Antiepileptic Drug (NAAED) Pregnancy Registry.

RECOMMENDATION: Before starting topiramate, pregnant women and women of childbearing potential should discuss other treatment options with their health care professional. Women taking topiramate should tell their health care professional immediately if they are planning to or become pregnant. Patients taking topiramate should not stop taking it unless told to do so by their health care professional. Women who become pregnant while taking topiramate should talk to their health care professional about registering with the North American Antiepileptic Drug Pregnancy Registry, a group that collects information about outcomes in infants born to women treated with antiepileptic drugs during pregnancy.

See Drug Safety Communication for additional information, including a data summary and recommendations for healthcare professionals and patients.

Read the MedWatch safety alert, including links to the Drug Safety Communication, Q&As, and FDA News Release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

FDA提醒醫護人員及病人，懷孕婦女使用Topamax (topiramate)會增加新生兒唇顎裂的風險。因為新的人體資料顯示topiramate會增加顎裂的風險，所以懷孕分級劃分為D，表示對於人類嬰兒的風險已被證實，但使用藥品的利益與風險在某些經過合理評估的情況下，或許仍可接受其風險。Topamax及其學名藥的藥物使用指示及處方資訊將依據此新資料而更新。

Topiramate核可之適應症為癲癇，可單用或與其他藥物併用以治療特定型態之癲癇，另一核可之適應症為預防偏頭痛。此資料來源為North American Antiepileptic Drug (NAAED) Pregnancy Registry。

懷孕婦女或接近分娩期之婦女應在使用topiramate之前先與專業醫療人員討論，是否有其他用藥的選擇，計畫懷孕的婦女若正在使用topiramate應立即告知專業醫療人員，且在醫療人員提供停藥建議前不應擅自停藥。若在用藥期間發現懷孕，則應告知醫療人員做登記，幫助NAAED收集有關懷孕婦女使用抗癲癇藥之資料。

相關訊息與連結請參考FDA網址：http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm245777.htm
[Posted 03/04/2011]

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