Mar 27 2010
On October 8, 2009, King Pharmaceuticals, Inc. (King) received a Warning Letter from the Division of Drug Marketing, Advertising, and Communications (DDMAC) at the Food and Drug Administration (FDA) regarding two video news releases - EMBEDA Media backgrounder, and EMBEDA Visual Media Technology (news releases), for EMBEDA® (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules for oral use C-II (EMBEDA). The FDA stated that the news releases were false or misleading because they omitted and minimized the risks associated with EMBEDA, failed to present the limitations to its approved indication, and presented misleading claims about EMBEDA.
To correct any false or misleading impression you may have gained from the news releases, King is providing you with the following clarifying information about EMBEDA.
In addition, EMBEDA is associated with a number of serious adverse reactions:
Serious adverse reactions that may be associated with EMBEDA therapy in clinical use include: respiratory depression, respiratory arrest, apnea, circulatory depression, cardiac arrest, hypotension, and/or shock.
For further information please refer to full prescribing information at the following link: www.EMBEDA.com.
Source:
King Pharmaceuticals, Inc.
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