Meprobamate 藥物濫用與副作用風險 !!! TFDA令下架

衛福部註銷抗焦慮劑meprobamate藥證【聯合報╱記者詹建富╱即時報導】 2014.02.11 09:21 am 衛生福利部食品藥物管理署今天公告，由於抗焦慮劑meprobamate經研究發現，造成嚴重致命性的神經性不良反應 (包括昏迷)等風險，即日起將註銷包括榮民製藥廠生產的「美普魯巴寐錠」等七張藥品上市許可證，業者應應立即下架回收，並停止輸入、製造、批發、調劑、零售。食藥署藥品組副組長戴雪詠表示，meprobamate屬於一種非常古老的抗焦慮劑，但由於歐盟等國家陸續發現它有不良副作用，且該署彙集國內、外相關資料及臨床相關文獻，評估其臨床效益及風險，認為國內既有其他較安全的替代藥品可供治療選擇，因此決定廢止含該成分製劑的藥品許可證。這些被註銷的藥證計有六款藥品、七張藥證，包括人生製藥「可利靜錠」、榮民製藥、華盛頓製藥「息痛錠」、信東生技「安達樂神片」、中國化學製藥「安其心片」、中央藥品「神舒寧片」。【2014/02/10 聯合報】

When Miltown came out in 1954, it was a miracle drug. Miltown, along with other newly invented "minor" tranquilizers introduced in the era, enabled half of the patients in America's mental hospitals to be released and lead everyday lives, saving taxpayers billions of dollars. At that time, Americans had not yet become cynical about drugs. "Staying calm" was a virtue when nuclear war was a threat. Indeed, the U.S. Civil Defense Department advised the public to keep a supply of tranquilizers in their fallout shelters. Within ten years of its introduction, Miltown was America's number one addiction after cigarettes and alcohol, and it represented one-third of all prescribed drugs. It was a blockbuster drug among the Hollywood crowd, and considered safe, harmless and useful. Demand was patient-driven — people learned about its wonders from neighbors, friends and even Milton "Miltown" Berle, a popular TV comedian. By 1966, 80 million Americans had tried Miltown and 200 had committed suicide with it. It was becoming evident that Miltown was addictive and eventually, the U.S. government had to declare it a Schedule IV Classified Substance. In January 2012, the European Medicines Agency suspended the use of all products containing meprobamate, the ingredient in Miltown, because of serious side effects. The agency noted that "its benefits do not outweigh its risks." Today Miltown and other meprobamate drugs are still available and widely abused in the United States, even though they have been mostly replaced by better and more modern tranquilizers.

Source: http://www.drugaddictiontreatment.com/

Meprobamate (brand name Miltown, Equanil and Meprospan) is a an anti-anxiety drug that was once the best-selling minor tranquilizer in the United States. It has largely been replaced by benzodiazepines such as Valium, Librium, and Xanax. Meprobamate is a Schedule IV drug under the Convention on Psychotropic Substances. Symptoms of Meprobamate overdose include drowsiness, unresponsiveness, loss of muscle control, severe impairment or cessation of breathing, coma, and shock. Death has been reported with ingestion of as little as 12 grams of Meprobamate. Prolonged use of Meprobamate can lead to physical dependence and has a life-threatening abstinence syndrome similar to alcohol and barbiturates. Sudden abstinence from Meprobamate can lead to severe reactions including insomnia, vomiting, tremor, muscle twitching and overt anxiety in the first 3 to 4 days. Acute psychotic reactions and hallucinations resembling delirium tremens have been noticed in severe cases of Mebrobamate abuse. Medically supervised detoxification (detox) followed by psychosocial treatment is highly recommended in cases of long-term Mebprobamate abuse and dependence.