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Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 4 Mar 2008 06:33:35 -0600 (CST)
Subject: CDRH New Update
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| FDA Home Page | CDRH Home Page | Search | A-Z Index |  | |
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 | Date: March 4, 2008 |
The following new items were added to the CDRH web pages on March 3, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Expedited Review of Premarket Submissions for Devices - Guidance for Industry and FDA Staff |  |  |
| Radiological Devices Panel Advisory Meeting, March 4-5, 2008 - Agenda, Roster, Draft Questions | |
Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 4 Mar 2008 09:11:34 -0600 (CST)
Subject: MedWatch - Tamiflu (oseltamivir) associated with neuropsychiatric events, including delirium and abnormal behavior leading to injury
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Roche and FDA informed healthcare professionals of neuropsychiatric events associated with the use of Tamiflu, in patients with influenza. These symptoms, as described in post marketing reports mostly from Japan, include delirium and abnormal behavior leading to injury, and in some cases resulting in fatal outcomes. These events were reported primarily among pediatric patients and often had an abrupt onset and rapid resolution. Patients with influenza should be closely monitored for signs of abnormal behavior. If neuropsychiatric symptoms occur, the risks and benefits of continuing treatment should be evaluated.
See the MedWatch 2008 safety summary, including links to the Dear Healthcare Professional letter and Tamiflu Prescribing Information, at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tamiflu
Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 4 Mar 2008 14:51:20 -0600 (CST)
Subject: FDA MedWatch -Aspire36 and Aspire Lite -Nationwide Recall Of Dietary Supplements Because Products Contained an Analog Of Sildenafil
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Palo Alto Labs and FDA notified consumers and healthcare professionals of a voluntary nationwide recall of two dietary supplements, Aspire36 and Aspire Lite. The products were recalled because they were found to contain Aildenafil in trace amounts and Dimethyl sildenafil thione, an analog of Sildenafil, a drug used to treat erectile dysfunction. The presence of these ingredients in the dietary supplements may pose a threat to consumers because the analogue may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers who have Aspire36 and Aspire Lite in their possession should stop using the products and return any unused product to the place of purchase.
Read the complete 2008 MedWatch Safety Summary, including a link to the manufacturer's press release regarding this issue:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Aspire
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