Update : 1
Subject: Public Health Notifications Update
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.
Update : 2
Subject: Drug Safety Newsletter Update
FDA releases its second issue of the FDA Drug Safety Newsletter at http://www.fda.gov/cder/dsn/2008_winter/toc.htm.
Update : 3
Subject: Getting Up to Date on Glucose Meters
Getting Up to Date on Glucose Meters
Tue, 18 Mar 2008 13:12:00 -0500
FDA is reminding consumers to only use the test strips that are recommended for use with their glucose meter.
Update : 5
Subject: MedWatch - Medtronic AneuRx Stent Graft System: Updated information on mortality risks
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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
Update : 6
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
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The entire online newsletter can be found at http://www.fda.gov/cder/dsn/2008_winter/toc.htm
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Update : 7
Subject: MedWatch - Tiotropium (marketed as Spiriva HandiHaler): ongoing safety review - possible increased risk of stroke
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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.
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tiotropium
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