Metoclopramide...이상운동 부작용경고

'멕소롱' 성분 이상운동 부작용 경고

연합뉴스 | 입력 2009.02.28 07:15

 

(서울=연합뉴스) 하채림 기자 = 멀미약과 구토예방, 소화제로 널리 쓰이는 메토클로프라미드 성분의 의약품에 대해 치료 불가능한 이상운동 부작용을 유발한다는 경고가 나왔다.

28일 제약업계에 따르면 미국 식품의약국(FDA)은 최근 소화기관조절 약물인 메토클로프라미드를 장기간 또는 고용량으로 복용하면 '지연성 이상운동'(tardive dyskinesia)을 유발할 위험이 있다며 이 성분을 함유한 의약품에 이 같은 내용을 담은 상자형 경고문을 부착하도록 했다.

이상운동이란 자신의 의사와 상관없이 입술, 혀, 손가락, 목 등 신체의 부자연스러운 움직임이나 눈 깜박임 등이 계속되는 증상을 말하며 지연성 이상운동은 약물을 복용을 중단한 후에도 이러한 증상이 지속되는 것을 뜻한다. 일단 이상운동 증상이 생기면 사라지지 않으며 치료법도 없다.

메토클로프라미드는 '멕소롱'을 비롯한 구토억제제와 소화제로 일반의약품과 전문의약품에 널리 쓰이고 있는 성분으로 국내에는 이 성분이 들어 있는 의약품 40여종이 시판허가를 받았다.

FDA에 따르면 메토클로프라미드는 약물로 인한 이상운동의 가장 주요한 원인이며 부작용 발생 가능성은 이 약물의 복용기간이나 복용량에 직접적으로 관련이 있다.

또 메토클로프라미드 부작용은 노인 특히 여성노인에게서 더 빈번하다고 FDA는 전했다.
FDA는 "메토클로프라미드 복용으로 이상운동 증세가 생긴 환자들 대부분 이 약을 3개월 이상 복용했다"며 "이 성분의 소화기관 약물의 복용기간은 3개월을 넘기지 않는 것이 좋다"고 권고했다.

tree@yna.co.kr

 

FDA News

FOR IMMEDIATE RELEASE Feb. 26, 2009

Media Inquiries: Christopher Kelly, 301-796-4676 Consumer Inquiries: 888-INFO-FDA

 

FDA Requires Boxed Warning and Risk Mitigation Strategy

for Metoclopramide-Containing Drugs

Agency warns against chronic use of these products to treat gastrointestinal disorders

The U.S. Food and Drug Administration announced today that manufacturers of metoclopramide, a drug used to treat gastrointestinal disorders, must add a boxed warning to their drug labels about the risk of its long-term or high-dose use. Chronic use of metoclopramide has been linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drugs are no longer taken.

Manufacturers will be required to implement a risk eval!uation and mitigation strategy, or REMS, to ensure patients are provided with a medication guide that discusses this risk.

“The FDA wants patients and health care professionals to know about this risk so they can make informed decisions about treatment,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Eval!uation and Research. “The chronic use of metoclopramide therapy should be avoided in all but rare cases where the benefit is believed to outweigh the risk.”

Current product labeling warns of the risk of tardive dyskinesia with chronic metoclopramide treatment. The development of this condition is directly related to the length of time a patient is taking metoclopramide and the number of doses taken. Those at greatest risk include the elderly, especially older women, and people who have been on the drug for a long time.

Tardive dyskinesia is characterized by involuntary, repetitive movements of the extremities, or lip smacking, grimacing, tongue protrusion, rapid eye movements or blinking, puckering and pursing of the lips, or impaired movement of the fingers. These symptoms are rarely reversible and there is no known treatment. However, in some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped.

Metoclopramide works by speeding up the movement of the stomach muscles, thus increasing the rate at which the stomach empties into the intestines. It is used as a short-term treatment of gastroesophageal reflux disease in patients who have not responded to other therapies, and to treat diabetic gastroparesis (slowed emptying of the stomach’s contents into the intestines). It is recommended that treatment not exceed three months.

Metoclopramide is available in a variety of formulations including tablets, syrups and injections. Names of metoclopramide-containing products include Reglan Tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution, and Reglan Injection. More than two million Americans use these products.

Recently published analyses suggest that metoclopramide is the most common cause of drug-induced movement disorders. Another analysis of study data by the FDA showed that about 20 percent of patients in that study who used metoclopramide took it for longer than three months. The FDA has also become aware of continued spontaneous reports of tardive dyskinesia in patients who used metoclopramide, the majority of whom had taken the drug for more than three months.

Consumers and health care professionals are encouraged to report adverse events to the FDA's MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, Md. 20852-9787, or online at: www.fda.gov/medwatch/report.htm