關(guān)鍵詞： 美國FDA 藥物安全
2012年12月25日訊 /生物谷BIOON/ --美國FDA在12月21日在網(wǎng)站上警告不要擅自使用來自國外的未經(jīng)批準(zhǔn)的藥物，因?yàn)檫@些藥物有可能是偽造、受污染或者是未正確儲(chǔ)存,、運(yùn)輸,、失效的。
FDA同時(shí)要求各醫(yī)療機(jī)構(gòu)要嚴(yán)格檢查所購買的藥物是否符合相關(guān)標(biāo)準(zhǔn)并確保這些藥物來源于FDA審核并批準(zhǔn)的藥物供應(yīng)商以保證患者的安全,。
此前,，在2012年內(nèi)FDA就國外供應(yīng)藥物的安全問題共發(fā)出5次警告。（生物谷Bioon.com）
詳細(xì)英文報(bào)道：
More than 350 medical practices in the United States may have received unapproved medications, including unapproved versions of Botox, from a foreign supplier, the US Food and Drug Administration (FDA) warned on its Web site this week.
"These medications may be counterfeit, contaminated, improperly stored and transported, ineffective, and/or unsafe. Medical practices that purchase and administer illegal and unapproved medications from foreign sources are placing patients at risk and potentially depriving them of proper treatment," the agency said.
The FDA has sent a letter to the physicians or medical practices involved informing them of the situation.
A list of the doctors and clinics that received the letter is available here.
Products Not FDA Approved
To reduce the chance of patients receiving an unapproved, counterfeit, unsafe, or ineffective medication, the FDA is asking that medical practices stop administering the unapproved versions of Botox and any other products they have received from foreign suppliers owned and operated by Canada Drugs and known under the following names: Quality Specialty Products (QSP), A+ Health Supplies, QP Medical, Bridgewater Medical, or Clinical Care.
"Many, if not all, of the products sold and distributed by these suppliers have not been approved by FDA. Therefore, FDA cannot confirm that the manufacture and handling of these products follow U.S. regulations or that these medications are safe and effective for their intended uses," the FDA said. Medications not approved by the FDA may also lack the necessary and required labels that ensure their appropriate and safe use, the agency reminds clinicians.
So far in 2012, the FDA has issued letters to medical practices in the United States that purchased unapproved medications from foreign suppliers 5 times: on February 10, April 5, April 23, June 28, and September 10.
The FDA is asking healthcare providers to examine their purchasing practices to ensure that products are purchased directly from the manufacturer or from state-licensed wholesale drug distributors in the United States.
"Health care professionals, pharmacies, and wholesalers/distributors are valuable partners in efforts to protect consumers from the risks of unsafe or ineffective products that may be stolen, counterfeit, contaminated, or improperly stored and transported. The receipt of suspicious or unsolicited offers from unknown suppliers should be questioned, and extra caution should be taken when considering them," the FDA said.
Healthcare providers are asked to report suspected criminal activity to FDA's Office of Criminal Investigations (OCI) by calling 1-800-551-3989 or visiting the OCI Web site.
The FDA has provided information on its Web site on how to verify that a wholesale drug distributor is licensed in the state(s) where it is conducting business.
