FDA警告：补充剂Intestinomicina含氯霉素可能有毒

圣路易斯(MD Consult)——2012年9月18日，美国食品药品管理局(FDA)发布了一则安全性警告，要求消费者不要服用Intestinomicina——一种在萨尔瓦多生产、据称可治疗感染性腹泻和急性胃肠道感染的药物。Intestinomicina含有处方药成分氯霉素。口服剂型的氯霉素已于2012年7月被正式撤出美国市场，原因是可能导致严重甚至危及生命的伤害。

与口服氯霉素相关的最严重、危及生命的损害为骨髓毒性。特定类型的骨髓毒性是可逆的，然而，在罕见情况下骨髓毒性可导致死亡。患有贫血、低白/红细胞计数或血小板水平下降的患者，最可能发生死亡或严重损害。

Intestinomicina的标签主要采用西班牙语，在成分中标出了chloramfenicol palmitato以及氯霉素的英文。这种药物的片剂和水剂在市场上均可找到，由Laboratorios Lopez销售。已发现美国一些以销售南美洲与中美洲食品和产品为特色的国际性食品商店正在销售这种药物。

该产品的标签还列出了包括新霉素(局部用药的常用成分)和磺胺类药物在内的抗菌成分。新霉素和磺胺类药物有可能导致多种不良反应，轻至皮疹、荨麻疹，重至严重甚至危及生命的不良事件。

Intestinomicina还可能与其他药物发生相互作用。

建议医务人员和消费者将与Intestinomicina有关的任何不良事件报告至FDA的MedWatch不良事件报告系统。

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ST LOUIS (MD Consult) - On September 18, 2012, the US Food and Drug Administration (FDA) issued a safety alert, warning consumers not to take Intestinomicina, a drug product manufactured in El Salvador and marketed as a treatment for infectious diarrhea and acute gastrointestinal infections. Intestinominica contains the prescription drug ingredient, chloramphenicol. Oral forms of chloramphenicol were formally withdrawn from the US market in July 2012 because of the risk of serious and life-threatening injuries.

The most serious and life-threatening injury associated with oral chloramphenicol treatment is bone marrow toxicity. Certain types of bone marrow toxicity are reversible; however, in rare circumstances it can lead to death. Patients with anemia, low white- or red-blood cell counts, or decreased levels of blood platelets may be at a greater risk of death or serious injury.

Intestinomicina is labeled primarily in Spanish and lists the ingredient as chloramfenicol palmitato, or chloramphenicol in English, on the label. It can be found in tablet and liquid forms and is manufactured by Laboratorios Lopez. The product has been found in international grocery stores in the United States that feature South and Central American specialty foods and products.

The product label also lists antibacterial ingredients including neomycin, an antibiotic often found in topical medications, as well as sulfa drugs. Neomycin and sulfa drugs have the potential to cause a variety of adverse reactions, ranging from rashes and hives, to severe and life-threatening reactions.

Intestinomicina may also interact with other medications.

Health care professionals and consumers are encouraged to report any adverse events related to Intestinomicina to the FDA's MedWatch Adverse Event Reporting Program.