ST LOUIS (MD Consult) - The US Food and Drug Administration (FDA) issued a final rule that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labeling to include warnings about potential safety risks, such as internal bleeding and liver damage, associated with the use of these popular drugs.

Products covered by the FDA action include acetaminophen and a class of drugs known as the nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs include aspirin, ibuprofen, naproxen, and ketoprofen. Acetaminophen is in a class by itself. The revised labeling applies to all OTC pain relievers and fever reducers, including those that contain one of these ingredients in combination with other ingredients, such as in cold medicines containing pain relievers or fever reducers.

"Acetaminophen and NSAIDs are commonly used drugs for both children and adults because they are effective in reducing fevers and relieving minor aches and pain, such as headaches and muscle aches," said Charles Ganley, MD, director, FDA's Office of Nonprescription Drugs in the Center for Drug Evaluation and Research. "However, the risks associated with their use need to be clearly identified on the label so that consumers taking these drugs are fully aware of the potential harm they can cause. It is important that they know how to take these medications safely to reduce their risk."

Under the final rule, manufacturers must ensure that the active ingredients of these drugs are prominently displayed on the drug labels on both the packages and bottles. The labeling also must warn of the risks of stomach bleeding for NSAIDs and severe liver damage for acetaminophen.

Since 2006, some manufacturers have voluntarily revised their product labeling to identify these potential safety concerns. However, the voluntary changes to labeling do not address all of the labeling requirements in the new rule. For example, the new rule includes a warning on products containing acetaminophen that instructs consumers to ask a doctor before they take the blood-thinning drug warfarin. The new rule requires all manufacturers to relabel their products within 1 year of April 28, 2009.

Safety data reported in medical literature indicate people sometimes take more acetaminophen than the label recommends. Others unknowingly take multiple products containing acetaminophen at the same time. Exceeding the recommended dosage of acetaminophen may increase the risks for severe liver damage. Alcohol use can also increase the risk of liver damage with acetaminophen.

The risk for stomach bleeding may increase in people who use NSAIDs and who are taking blood-thinning drugs (anticoagulants) or steroids. Stomach-bleeding risks also increase for people who take multiple NSAIDs at the same time and in people who take them longer than directed. Alcohol use can increase the risk for stomach bleeding with NSAID use.

An FDA Advisory Committee meeting will be convened on June 29-30, 2009, to discuss further steps the FDA could take to reduce the risk of liver damage associated with acetaminophen overdoses.

To read the final rule on the relabeling of OTC pain relievers and fever reducers, go to www.accessdata.fda.gov/scripts/oc/ohrms/advdisplay.cfm.

To read the Federal Register Notice announcing the FDA Advisory Committee meeting, see www.fda.gov/OHRMS/DOCKETS/98fr/E9-9380.pdf.

OTC Pain Relievers

Acetaminophen: Tylenol and other brands.

NSAIDS

Aspirin: Bayer and other brands.

Ibuprofen: Advil, Motrin, and other brands.

Naproxen: Aleve and other brands.

Source: FDA

圣路易斯 (MD Consult)——美国食品和药物管理局（ FDA ）发布最终规定，要求制药商修改非处方（OTC）止痛药和退热药的标签，包括增加关于潜在安全风险的警告，例如应用该类常用药物可能导致内脏出血和肝脏损伤。

FDA法案涵盖的药品包括对乙酰氨基酚和非类固醇类抗炎药（NSAIDs）。NSAIDs包括阿司匹林、布洛芬、萘普生和酮洛芬。对乙酰氨基酚本身归为一类。经修订的标签规定适用于所有非处方止痛药和退热药，包括那些含有这些成分的药物，如含有止痛药或退热药成分的感冒药。

FDA药物评价和研究中心非处方药品办公室主任Charles Ganley博士表示，“对乙酰氨基酚和非类固醇类抗炎药是儿童和成年人的常用药物，因为它们可以有效地退热和缓解轻微疼痛，如头痛和肌肉疼痛。然而，标签上需要明确写明与服用药物相关的风险，使服用这些药物的消费者充分认识到药物可能导致的潜在危害。重要的是，应使他们知道如何安全地服用这些药物，以减少风险。”

根据该项规定，制药商必须确保在药物的外包装和瓶子上均显著标明药物的活性成分。标签还必须增加关于非类固醇类抗炎药相关胃出血风险和对乙酰氨基酚相关严重肝损伤的警告。

自2006年以来，一些制药商自行修订其产品标签，标明了这些潜在的安全问题。然而，这些自行更改的标签并不完全符合新规定的要求。例如，新规定要求对含有对乙酰氨基酚的药物必须标明警告，并建议消费者在同时服用抗凝血药华法林前要咨询医生。新规定要求所有制药商在自2009年4月28日起1年内更换标签。

医学文献中的安全性数据表明，患者有时服用对乙酰氨基酚的量比标签推荐剂量更大。部分患者有时在不知情的情况下同时服用多种含有对乙酰氨基酚的药物。服用超过推荐剂量的对乙酰氨基酚可能会增加肝损伤的风险。服药同时饮酒也可以增加肝损伤的风险。

服用非类固醇类抗炎药和服用抗凝血药或类固醇均会增加胃出血的风险。同时服用多种非类固醇类抗炎药或超过建议疗程长时间服用非类固醇类抗炎药也增加胃部出血的风险。服用非类固醇类抗炎药同时饮酒能增加胃出血的风险。

定于2009年6月29～30日举行的FDA咨询委员会会议将就FDA为降低对乙酰氨基酚过量相关肝损伤风险的下一步计划进行讨论。

欲了解关于更换非处方止痛药和退热药标签的最终规定，请参阅：

www.accessdata.fda.gov/scripts/oc/ohrms/advdisplay.cfm.

欲了解宣布FDA咨询委员会会议事宜的联邦注册公告，请参阅：

www.fda.gov/OHRMS/DOCKETS/98fr/E9-9380.pdf

非处方止痛药

对乙酰氨基酚：泰诺和其他品牌。

非类固醇类抗炎药

阿司匹林：拜耳公司和其他品牌。

布洛芬：布洛芬、Motrin以及其他品牌。

萘普生： Aleve和其他品牌。

资料来源：美国FDA

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