Krenzelok Edward P
Pittsburgh Poison Center and Drug Information Center, University of Pittsburgh Medical Center, Schools of Pharmacy and Medicine, University of Pittsburgh, Pittsburgh, PA 15213, USA.
Clin Toxicol (Phila). 2009 Sep;47(8):784-9. doi: 10.1080/15563650903232345.
Unintentional acetaminophen toxicity is a common problem throughout the world but particularly in the more developed countries. To deal with the problem, several countries have attempted to decrease the risk of acetaminophen overdose by reducing package sizes. The U.S. Food and Drug Administration (FDA) convened a joint meeting recently of three Advisory Committees to consider the issue of unintentional acetaminophen-related toxicity and to explore strategies to address the problem.
Three strategies addressed the issue of dose reduction as a way to decrease morbidity and mortality. The FDA proposed a decrease in the maximum daily dose from 4,000 to 3,250 mg, reducing the maximum individual dose from 1,000 to 650 mg and relegating 500 mg tablets to prescription status. The Committees voted in favor of each of those initiatives. Restricting the number of doses that could be purchased by regulating package sizes, as has been done in some European countries, was proposed, but rejected by the Committees. Proposals also addressed the elimination of nonprescription and prescription acetaminophen combination products (e.g., multi-symptom cold relief combinations and acetaminophen/opioid combinations) as a strategy to decrease unintentional poisoning when individuals unknowingly take different products, all of which contain acetaminophen. The Committees rejected the proposal to eliminate the nonprescription combinations but recommended the elimination of prescription combination products. Currently, liquid acetaminophen is available in the United States in three different concentrations. To reduce the confusion associated with the variance in concentrations the Committees voted to have a single concentration for all acetaminophen liquid products. Finally, the Committees voted, almost unanimously, to encourage the FDA to place a boxed warning in the product information to create awareness among prescribers and pharmacists about acetaminophen toxicity and to educate their patients accordingly.
Many of the recommendations were not evidence-based but instead have an anecdotal basis. However, the Committees are advisory to the FDA, their recommendations are not binding and it remains to be seen which of the recommendations will be implemented.
对乙酰氨基酚意外中毒是全球普遍存在的问题，在较为发达国家尤为如此。为应对该问题，一些国家试图通过减小包装尺寸来降低对乙酰氨基酚过量服用的风险。美国食品药品监督管理局（FDA）最近召集了三个咨询委员会的联席会议，以审议对乙酰氨基酚相关意外中毒问题，并探讨解决该问题的策略。
三种策略涉及降低剂量以减少发病率和死亡率的问题。FDA提议将最大日剂量从4000毫克降至3250毫克，将最大单次剂量从1000毫克降至650毫克，并将500毫克片剂列为处方药。委员会对这些举措均投了赞成票。有人提议像一些欧洲国家那样通过规定包装尺寸来限制可购买的剂量数量，但遭到了委员会的否决。提议还涉及取消非处方和处方对乙酰氨基酚复方产品（如多症状感冒缓解复方制剂和对乙酰氨基酚/阿片类复方制剂），作为当个体在不知情的情况下服用不同产品（所有产品均含有对乙酰氨基酚）时减少意外中毒的一种策略。委员会否决了取消非处方复方制剂的提议，但建议取消处方复方产品。目前，美国有三种不同浓度的对乙酰氨基酚液体制剂。为减少因浓度差异带来的混淆，委员会投票决定所有对乙酰氨基酚液体制剂采用单一浓度。最后，委员会几乎一致投票鼓励FDA在产品信息中设置黑框警告，以使开处方者和药剂师了解对乙酰氨基酚的毒性，并相应地对患者进行教育。
许多建议并非基于证据，而是基于轶事。然而，委员会是向FDA提供咨询的，其建议不具约束力，哪些建议将被实施还有待观察。
