Warning issued by FDA about breast cancer drug
09/15/2015 // JusticeNewsFlash // (press release)
Washington – A warning has been issued by the Food and Drug Administration concerning the use of the breast cancer drug Trastuzumab. Inquirer.net reported that the drug has not undergone registration and evaluation by the government for ensuring its safety and effectiveness.
The regulating agency’s advisory refers to the medication marketed under the name CANMab 440 mg Lypophilised Powder for I.V. infusion. The warning states the drug poses potential risks to consumers and that selling or importing it in the U.S. violates the Food and Drug Administration Act of 2009.
The FDA advisory, which has been signed by Health Secretary Janette Garin, who is acting director general of the agency, states “All healthcare professionals and the general public are hereby warned to be vigilant of the drug product.”
The FDA has ordered seizure of the unregistered product by its field regulatory operations. The advisory further states “All consumers are advised to purchase their medications only from FDA-licensed establishments.”
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Source: Inquirer News Story http://newsinfo.inquirer.net/721668/fda-issues-warning-on-unregistered-breast-cancer-drug