From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 14 Jul 2008 06:17:43 -0500 (CDT)
Subject: CDRH New Update
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| FDA Home Page | CDRH Home Page | Search | A-Z Index |  | |
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 | Date: July 14, 2008 |
The following new items were added to the CDRH web pages on July 11, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Federal Register: Global Harmonization Task Force, Study Groups 1 and 5; Proposed and Final Documents; Availability. |  |  |
| Federal Register: Guidance for Industry and Food and Drug Administration Staff; Surveillance and Detention Without Physical Examination of Condoms; Availability. | | |
| Federal Register: Guidance for Industry and Food and Drug Administration Staff; Surveillance and Detention Without Physical Examination of Surgeons' and/or Patient Examination Gloves; Availability. | | |
| Consumer Information on: Medtronic® Attain StarFix™ Model 4195 Lead - P060039 | |
Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 14 Jul 2008 13:51:32 -0500 (CDT)
Subject: Possible Malfunction of Electronic Medical Devices Caused by Computed Tomography (CT) Scanning - Medical Device Safety
A new preliminary public health notification is alerting healthcare professionals of the possibility that x-rays used during CT exams may cause some implanted and external electronic medical devices to malfunction.
Update: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 14 Jul 2008 14:08:54 -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 regarding possible malfunction of electronic medical devices caused by CT scanning. This Notification alerts healthcare practitioners to the possibility that the x-rays used during CT examinations may cause some implanted and externally worn electronic medical devices to malfunction and provides recommendations to reduce the potential risks.
This Notification is available by clicking here.
Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 14 Jul 2008 13:41:41 -0500 (CDT)
Subject: FDA MedWatch- Avastin (bevacizumab) and sunitinib malate- Reports of Microangiopathic Hemolytic Anemia In Patients Treated With This Combination
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Genentech, Inc. informed healthcare professionals of reports of several cases of microangiopathic hemolytic anemia (MAHA) in patients with solid tumors receiving Avastin in combination with sunitinib malate. Avastin is not approved for use in combination with sunitinib malate and this combination is not recommended. Twenty-five patients were enrolled in a Phase I dose-escalation study combining Avastin and sunitinib malate. The study consisted of 3 cohorts using a fixed dose of Avastin at 10mg/kg/IV every 2 weeks and escalating doses of sunitinib that included 25, 37.5, and 50 mg orally daily given in a 4 weeks on/ 2 weeks off schedule. Five of 12 patients at the highest sunitinib dose level exhibited laboratory findings consistent with MAHA. Two of these cases were considered severe with evidence of thrombocytopenia, anemia, reticulocytosis, reductions in serum haptoglobin, schistocytes on peripheral smear, modest increases in serum creatinine levels, and severe hypertension, reversible posterior leukoencephalopathy syndrome, and proteinuria. The findings in these two cases were reversible within three weeks upon discontinuation of both drugs without additional interventions. Healthcare professionals should report cases of MAHA or any serious adverse events suspected to be associated with the use of Avastin.
Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's Dear Healthcare Provider Letter regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Avastin
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