U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

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Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 18 Mar 2008 08:10:14 -0500 (CDT)
Subject: Public Health Notifications Update

You are subscribed to Public Health Notifications for U.S. Food & Drug Administration (FDA), Center for Devices and Radiological Health.

The FDA has posted a new Public Health Notification providing updated data on Mortality Associated with the Medtronic AneuRx Stent Graft System. 

This Notification is available by clicking here.

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 18 Mar 2008 11:18:05 -0500 (CDT)
Subject: MedWatch - Medtronic AneuRx Stent Graft System: Updated information on mortality risks

FDA issued a Public Health Notification to inform healthcare professionals of an update to earlier FDA safety information on this product. The notification re-emphasizes the need for continued surveillance of patients treated with endovascular grafts, and provides updated information on the mortality risks associated with the use of the AneuRx Stent Graft System to prevent abdominal aortic aneurysm rupture.

Read the complete MedWatch 2008 safety summary, including a link to the Public Health Notification and previous MedWatch alerts, at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#AneuRx

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Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 18 Mar 2008 12:47:29 -0500 (CDT)
Subject: MedWatch - FDA Drug Safety Newsletter: new online issue available

The new quarterly issue of FDA's online Drug Safety Newsletter [DSN] has been published today. DSN highlights safety issues related to FDA-approved drug products, based on an assessment of the importance and timeliness of these issues to patient care and the seriousness of the adverse events. The current issue includes an article on 'Pharmacogenomics and Drug Safety" and  postmarket safety reviews of Exenatide/acute pancreatitis, PDE5 inhibitors/sudden hearing loss, and TNF-alpha antagonists/serious skin reactions.

The entire online newsletter can be found at http://www.fda.gov/cder/dsn/2008_winter/toc.htm

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Message: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 18 Mar 2008 14:24:33 -0500 (CDT)
Subject: MedWatch - Tiotropium (marketed as Spiriva HandiHaler): ongoing safety review - possible increased risk of stroke

Boehringer Ingelheim and FDA notified healthcare professionals that ongoing safety monitoring has identified a possible increased risk of stroke in patients who take Spiriva. This product contains tiotropium bromide and is used to treat bronchospasm associated with chronic obstructive pulmonary disease. Boehringer Ingelheim reported to the FDA that it has conducted an analysis of the safety data from 29 placebo controlled clinical studies (“pooled analysis”). Based on data from these studies, the preliminary estimates of the risk of stroke are 8 patients per 1000 patients treated for one year with Spiriva, and 6 patients per 1000 patients treated for one year with placebo. This means that the estimated excess risk of any type of stroke due to Spiriva is 2 patients for each 1000 patients using Spiriva over a one year period. 

It is important to interpret these preliminary results with caution. FDA is working with Boehringer Ingelheim to further evaluate the potential association between Spiriva and stroke. FDA has not confirmed these analyses and while pooled analyses can provide early information about potential safety issues, these analyses have inherent limitations and uncertainty that require further investigation using other data sources. Patients should not stop taking Spiriva HandiHaler before talking to their doctor, if they have questions about this new information. This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. 

Read the complete MedWatch 2008 safety summary, including a link to the Early Communication, at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tiotropium

 

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