| Subject: | FDA Requests Label Change for Sedative-hypnotic Drug Products |
| Category: | Food and Drug Administration (FDA)
|
| Published: | Mon, 19 Mar 2007 - 12:00 am |
| Audience: Healthcare professionals, consumers
The FDA has notified healthcare professionals of its request that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labeling to include stronger language concerning potential risks.
These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving. Sleep driving is defined as driving while not fully awake after... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
|
RESOURCES:
Customizable Documents and Tools:
External Links:
|
|
With over 20 years experience in regulatory compliance, MCN Healthcare brings you the most comprehensive regulatory compliance tool available. StayAlert! is the only comprehensive e-mail notification service available that not only notifies you of the changes in major federal regulations, but also provides the policies, procedures, tools and best practices to help you meet the changing regulation. StayAlert! actively monitors TJC (JCAHO), CDC, CMS, DHHS, FDA, OSHA, OIG and many others so you don't have to. StayAlert! is the only comprehensive clinical and regulatory service providing organizations in the healthcare arena with practical applications to meet complex mandated federal requirements. |
|