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2020 年 3 月 17 日，根据《国家药监局关于注销安乃近注射液等品种药品注册证书的公告（2020 年 第 29 号）》，安乃近注射液 等品种存在严重不良反应，在我国使用风险大于获益，决定自即日起停止安乃近注射液、安乃近氯丙嗪注射液、小儿安乃近灌肠液、安乃近滴剂、安乃近滴鼻液、滴鼻用安乃近溶液片、小儿解热栓在我国的生产、销售和使用，注销药品注册证书（药品批准文号）。已上市销售的安乃近注射液等品种由生产企业负责召回，召回产品由企业所在地药品监督管理部门监督销毁。 根据《国家药监局关于修订安乃近相关品种说明书的公告（2020 年 第 34 号）》，安乃近说明书要求增加警示语：
安乃近，这款上世纪的退烧神药在我国的禁用情况又有了更新。回溯世界卫生组织（WHO）官方数据，自 1965 年起，已有 44 个国家先后对安乃近（英文名称 metamizole sodium）进行使用限制，措施涉及禁止进口、市场撤回、有限人群和条件使用等等，具体情况如下： 1965 澳大利亚：禁止进口 1976 挪威：撤出市场 Withdrawn from the market. 1977 菲律宾：有限使用 Used only as a last resort in serious and life-threatening situations when other less toxic antipyretic drugs and other measures have failed and are not tolerated, and only with proper supervision and monitoring. The package inserts are required to carry extensive warning information, especially regarding the risk of fatal agranulocytosis with the usage of this drug. The drug is available only on prescription. 1977 美国：撤出市场 An analgesic, antipyretic drug, found to be effective at reducing fever but withdrawn from the market and prohibited for export by the Food and Drug Administration on the basis of reports of agranulocytosis, a sometimes fatal blood condition, associated with its use.The Director of the Bureau of Drugs found that agranulocytosis cannot be effectively prevented by frequent examination of treated patients since this condition can occur within a few hours following administration of the drug to a sensitive individual. In its decision, the FDA cited the availability of effective orally administered drug products (e.g.acetylsalicylic acid or paracetamol) and concluded that the risks associated with this drug far outweigh any benefit derived from its use, including use in Hodgkin's disease and similar malignant diseases. 1978 科威特：有限使用 All dosage forms are no longer allowed with the exception of injectable preparations which may be used only in an emergency . 1979 意大利：部分撤出市场 Injectable preparations with dosages higher than 1 gram and intravenous preparations in combination with other compounds have been withdrawn. The label for currently marketed preparations now carries a warning regarding fatal accidents due to hypersensitivity. 1979 丹麦：禁止使用 Preparations containing metamizole were banned for systemic use due to the potential risk of fatal agranulocytosis. 1980 沙特阿拉伯：禁止使用 All preparations containing metamizole were prohibited due to several reports of anaphylactic shock. 1981 阿根廷：禁止使用 Pharmaceutical preparations containing metamizole sodium are banned. 1982 索马里：有限使用 The Ministry of Health no longer allows registration of metamizole sodium with the exception of parenteral preparations for limited use. 1982 保加利亚：有限使用 Banned in oral drops and tablet form due to high incidence of adverse effects and availability of safer alternatives. A single ingredient injection remains available for terminal care as a restricted drug for specialized use. 1983 埃及：有限注册 Following reports of anaphylactic shock, no registration licence is to be granted for injectable preparations containing more than 1gram of this compound. 1985 以色列：有限注册 Fixed dose combinations of metamizole sodium are not approved for registration. Parenteral preparations of metamizole sodium (single-dose product) may be administered only in hospitals and clinics where there are suitable facilities for resuscitation (in cases of anaphylactic shock). Enteral preparations of metamizole sodium (single-dose product) may be dispensed without prescription. 1987 比利时：有限使用 Preparations containing metamizole sodium have been placed in List IV of the 'Arr^t, duR,gent' of 2 June 1946 and as such can be administered only on prescription. They must be kept in a poisons cabinet and carry the skull and crossbones label. Metamizole in combination with a spasmolytic may be dispensed a maximum of five times against a renewable prescription for a period of six months. 1987 马来西亚：撤出市场 All products containing metamizole sodium have been withdrawn. 1987 德国：有限使用 Subsequent to the regulatory action taken in January 1983 (see Pyrazolones) the Federal Health Office has further restricted the use of preparations containing metamizole sodium. As from 1 January 1987 all preparations have been subjected to prescription control and combination products have been withdrawn. 1988 巴基斯坦：有限使用 All combination products containing metamizole sodium were withdrawn. 1989 西班牙：部分撤出市场 The indications of products containing metamizole sodium have been restricted to acute post-traumatic or post-surgical pain, abdominal colic and high fever unresponsive to other antipyretics. All fixed combination products containing metamizole have been withdrawn, except those in which it is associated with a spasmolytic. 1989 加纳：禁止使用 Products containing metamizole sodium of its salts have been banned. 1990 荷兰：部分撤出市场 Having regard to reports of agranulocytosis, the manufacturers have agreed to the voluntary withdrawal of metamizole sodium from combination preparations. 1992 瑞士：有限使用 Products containing metamizole sodium were subjected to prescription control. 1992 斯里兰卡：部分撤出市场 The Ministry of Health withdrew from sale pharmaceutical products containing metamizole sodium (injectable formulation).This action was based on the potential of these products to induce suppression of the bone marrow. 1994 泰国：有限使用 The Ministry of Public Health has revised the product information for pharmaceutical products containing the pyrazalone analgesic, metamizole sodium (dipyrone) to include a warning on possible agranulocytosis and impairment of the immune system and to restrict its use to severe pain and lack of response to aspirin or paracetamol. The drug has been rescheduled and may now be obtained only on prescription. It has also been prohibited for use in combination products, i.e.antispasmodic and cold remedy preparations. 1997 尼泊尔：撤出市场 The health authorities have banned the importation, manufacture, sale, distribution and storage of metamizole sodium alone or in combination. This action has been taken on the basis of safety concerns relating to this product. 1998 叙利亚：撤出市场 The Suprim Technical Committee and the Ministry of Health has instructed all local drug factories to stop manufacturing metamizole sodium (dipyrone) ampoules with immediate effect. 1998 也门：撤出市场 The Supreme Board of Drugs and Medical Appliances has withdrawn all formulations of metamizole sodium because of its potential to cause anaphylactic shock and agranulocytosis. 1998 津巴布韦：撤出市场 The Medicines Control Authority has cancelled the registration of all metamizole sodium (dipyrone)- containing products due to the potential risk of metamizole sodium causing fatal agranulocytosis. 1999 瑞典：撤出市场 The Medical Products Agency has suspended the marketing authorization for metamizole sodium with effect from 28 April 1999. The decision is based on a larger than expected number of reports of agranulocytosis in Sweden since 1996 (1 in 1,700). 2000 摩洛哥：撤出市场 The Minister of Public Health has decided to suspend the marketing authorization for products containing metamizole sodium on the recommendation of the National Advisory Commission for Pharmacovigilance. This recommendation followed an official survey which showed severe adverse reactions associated with this product. 2000 哥伦比亚：有限使用 The Institute Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) in Colombia,Colombian Ministry of Health has restricted the use of metamizole either alone or in combination.These products should be available only if other combination. These products should be available only if other therapeutic management is insufficient. 2000 立陶宛：撤出市场 The marketing authorization for tablets was not renewed for safety reasons. 2000 亚美尼亚：撤出市场 The Drug and Medical Technology Agency has suspended the marketing authorization of metamizole sodium (tablets and solution).The decision is based on a large number of reports on agranulocytosis in Sweden since 1996 and other dangerous adverse effects. 2000 巴林：撤出市场 Preparations containing metamizole sodium have been withdrawn. 2000 希腊：有限使用 Preparations containing metamizole have been withdrawn from the market, with the exception of injectable preparations containing up to 1 gram, because of concern about agranulocytosis associated with the drug's use. 2000 伊朗：部分撤出市场 Products containing metamizole have been withdrawn. 2000 墨西哥：有限使用 Due to toxicity, not accepted for use in pediatric preparations (elixir, solution, suspension,suppositories). Alternatives must be sought. 2000 秘鲁：有限使用 The package and/or label for this product advises that the drug is intended for prescription use only and may cause agranulocytosis. 2000 新加坡：禁止进口 Metamizole sodium and related salts have been banned for importation. 2000 瑞典：撤出市场 Preparations containing metamizole sodium were withdrawn from the market by the manufacturers after mutual discussions due to adverse reactions such as agranulocytosis. 2000 委内瑞拉：撤出市场 Not approved for use and/or sale. 2005 尼日利亚：撤出市场 In view of recorded cases of adverse reactions, the National Agency for Food and Drug Administration & Control (NAFDAC) has warned against the use of all brands of dipyrone drugs (Novalgin,Analgin, Optalgin,Drunalgin, Dr. Meyers Novalmin,Akarin,etc.). With effect from 1 September 205, the Agency will not allow the manufacture and importation of these drugs in any dosage form (injections, tablets and syrups) into the country. Also, with effect from 1st January 2006,the sale and use of all brands of matamizole drugs are banned. 2005 东帝汶：撤出市场 To be removed due to reports of agranulocytosis. 2005 塞尔维亚：有限使用 The labels of all registered products containing metamizole are required to include the boxed warning:'The use is not recommended in children and adolescents under the age of 18 years.' The use of products containing metamizole has been restricted to short term treatment of severe post-traumatic and post-surgical pains where other non-opioid analgesics shcm ineffectiveness. These measures are based on postmarketing reports of agranulocytosis (including one case with fatal outcome) associated with the use of metamizole, regulatory measures taken worldwide,and relevant medical literature. 2006 法国：撤出市场 Dipyone/metamizole/noramidopyrin containing products are no longer marketed due to negative benefit/risk evaluation. 2009 菲律宾：撤出市场 Metamizole has been banned in the Philippines. 2020 中国：有限使用 主要内容来源：
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