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09/17/09   |   By

FDA Mandates “Black Box” Warning for Promethazine | DC Metro Area Medical Malpractice Law Blog

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Posted by: Salvatore J. Zambri, Esquire

The AP (9/17, Johnson) reports that the FDA has determined that “[m]akers of injected promethazine, a sedative also used to treat nausea and vomiting, are being required to put the strongest warning possible on the product because it can cause tissue damage leading to amputation.” FDA regulators said that “makers of generic promethazine will have to put a ‘black box’ warning at the top of the detailed package insert explaining that when the drug is administered incorrectly, it can damage skin severely, including causing gangrene.”

We urge our readers to be very careful when taking this drug.  It is vitally important that you refrain from using it unless directed by a doctor, who is responsible for understanding all of the risks and benefits of the drug.  The risks should be communicated to you by your doctor before the physician prescribes the medication.

About the author:

Mr. Zambri is Past-President of the Trial Lawyers Association of Metropolitan Washington, DC and has been rated by Washingtonian magazine as a “Big Gun” and among the “top 1%” of all lawyers in the Washington metropolitan area.  The magazine also describes him as “one of Washington’s best–most honest and effective lawyers” who specializes in personal injury matters, including medical malpractice actions stemming from defective or dangerous medications.   He has also been named a “DC Super Lawyer” by Super Lawyer magazine (March/April 2009)–a national publication that honors the top lawyers in America.  If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

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