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Wednesday, February 19, 2014
FDA: ‘Natural Supplements’ Industry Victimizes Korean Community with Hidden Chemicals
By News Release @ 1:22 PM :: 4627 Views :: GMOs

Public Notification: Arth-Q Contains Hidden Drug Ingredient

News Release from FDA February 19, 2014 (Korean translation below)

The Food and Drug Administration (FDA) is advising consumers not to purchase or use Arth-Q, a product promoted and sold as a dietary supplement for joint, muscle and arthritic pain.

FDA laboratory analysis confirmed that Arth-Q contains the active ingredient, ibuprofen. Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID). NSAIDs may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage including bleeding, ulceration, and fatal perforation of the stomach and intestines. This hidden drug ingredient may interact with other medications and significantly increase the risk of adverse events, particularly when consumers already may be using NSAID-containing products. Arth-Q is labeled in English, but also promoted to the Korean-speaking community as “알쓰큐” or “알쓰Q.” It is a product sold on various websites, including www.kaymall.com, and in some retail stores.

Consumers should stop using this product immediately and throw it away. Consumers should consult a health care professional as soon as possible if they have experienced any negative side effects, such as unusually dark stools or urine, stomach pain, increased bruising, or other signs of bleeding.

Health care professionals and patients are encouraged to report adverse events or side effects related to the use of this product 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

Note: This notification is to inform the public of a growing trend of dietary supplements or conventional foods with hidden drugs and chemicals. These products are typically promoted for sexual enhancement, weight loss, and body building, and are often represented as being “all natural.” FDA is unable to test and identify all products marketed as dietary supplements on the market that have potentially harmful hidden ingredients. Consumers should exercise caution before purchasing any product in the above categories.

Please refer to the links below for more information:

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm385888.htm

Subscribe to the RSS feed: http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/TDS/rss.xml

Tainted Supplement Consumer Article: http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/UCM236998.pdf

Contact FDA

Toll Free

(855) 543-3784, or

(301) 796-3400

druginfo@fda.hhs.gov

  *   *   *   *    *

공지사항: 알쓰 큐에는 표시되지 않은 약 성분이 들어 있습니다

미국연방식품의약품안전청 (FDA)은 관절, 근육 및 신경통의 통증 완화를 위한 식품보조제로 선전 및 판매되는 알쓰큐 (Arth-Q)제품을 구입하거나 사용하지 않도록 공지 합니다.

미국연방식품의약품안전청의 실험분석에서 알쓰큐는 이부프로펜 활성성분을 함유 한 것이 확인

되었습니다. 이부프로펜은 비스테로이드성 항염제 (NSAID)입니다. 비스테로이드성 항염제는

심장마비 뇌졸증 등 심혈관계 질환 발생 및 심각한 출혈, 궤양과 더불어 치명적인 위장 및 장 천공 등 손상의 위험을 증가 시킬 수 있습니다. 표시되지 않은 이 약 성분은 다른 약물과 상호작용을 일으켜 부작용의 위험을 현저하게 증가 시킬 수 있으며 특히 비스테로이드성 항염제 성분이 들어있는 제품을 기왕에 복용하고 있는 소비자의 경우에는 더욱 그렇습니다. 알쓰큐는

영어로 표시되어 있으나 한인사회에서는 “알쓰큐” 또는 “알쓰Q”로 선전 되고 있습니다. 이 제품은 www.kaymall.com등 여러 군데의 웹사이트나 몇 군데의 소매상점에서 판매되고 있습니다.

소비자들은 이 제품의 사용을 즉시 중단하고 이 약을 폐기 처분 해야 합니다. 소비자들은 대 소변의 색깔이 유난히 검거나 위가 아프거나, 멍이 드는등 출혈의 다른 증상및 부작용이 있을 때는 전문의료인에게 진료를 받아야 합니다.

전문의료인들과 환자들은 이 제품사용과 관련 증상악화 및 부작용이 있을 경우 미국연방식품의약품안전청(FDA)의 약품감시 안전정보 및 부작용신고 프로그램MedWatch Safety Information and Adverse Event Reporting Program 에 신고해 주시기 바랍니다.

온라인으로 신고서를 작성하여 제출하시려면 다음의 링크로: www.fda.gov/MedWatch/report.htm

양식을 다운로드 하시려면 이 링크로 Download form 하시거나 1-800-332-1088로

전화하셔서 신고양식을 요청 하십시오. 작성을 마치면 반송주소가 적혀있는 봉투를

이용하시던가 1-800-FDA-0178로 팩스로 보내셔도 됩니다.

주의: 이 공지의 목적은 보조식품 이나 재래식품에 표시되지 않은 약물이나 화학성분이 점차

증가하고 있는 추세를 시민들 에게 알려 드리려는 것 입니다. 이러한 제품들은 성 능력 항진

체중감소, 바디빌딩 등에 유효하고 완전 천연성분 인 것처럼 선전되고 있습니다. 미국연방식품의약품안전청(FDA)는 현재 시중에서 표시되지 않은 잠재적 유해성분을 함유 한 채

식품보조제로 판매되고 있는 모든 제품을 찾아내어 시험할 수 없습니다. 소비자들은 위의 범주에 들어가는 제품을 구입시에는 조심 하셔야 합니다.

더 자세한 정보를 원하시면 다음의 링크를 이용 하십시오:

RSS .피드를 정기구독 하십시오:

http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/TDS/rss.xml

유해성분이 함유된 보조제 관련 기사들:

http://www.fda.gov/downloads/ForConsumers/Consumer/Updates/UCM236998.pdf

FDA에 연락 하시오

무료전화는

(855)543-3784 또는

(301)796-3400 를 이용해 주십시오

약물관련 정보는 다음의 링크로: druginfo@fda.hhs.gov

의약품정보HumanDrugInformation

의약품정보처 Division of Drug Information (CDER)

홍보실 Office of Communications

의견을 보내시려면 다음의 양식으로 Feedback Form

뉴햄프셔 애브뉴 10001 10001 New Hampshire Avenue

힐랜데일 빌딩 4층 Hillandale Building 4th Floor

실버스프링 매리랜드 20993 Silver Spring MD 20993

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