From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 10 Jul 2008 09:02:23 -0500 (CDT)
Subject: Stronger Warnings Requested for Fluoroquinolones
Stronger Warnings Requested for Fluoroquinolones
Thu, 10 Jul 2008 08:22:00 -0500
FDA has notified manufacturers of fluoroquinolones that a boxed warning on the increased risk of tendinitis and tendon rupture is necessary.
Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 10 Jul 2008 12:03:11 -0500 (CDT)
Subject: Salmolux Inc. Recalls Wild Alaskan Smoked Salmon Nova Lox Lot # 01418 Because of Possible Health Risk (July 9)
Salmolux Inc. Recalls Wild Alaskan Smoked Salmon Nova Lox Lot # 01418 Because of Possible Health Risk (July 9)
Thu, 10 Jul 2008 11:36:00 -0500
Salmolux Inc. of Federal Way, WA, is recalling lot # 01418 of its Wild Alaskan Smoked Salmon Nova Lox sold in 3 ounce packages due to the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Update: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 10 Jul 2008 13:39:28 -0500 (CDT)
Subject: U.S. Food & Drug Administration (FDA) CBER's Proposed and Final Rules Update
You are subscribed to CBER's Proposed and Final Rules for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine (Pentacel) - Summary Basis of Regulatory Action
Posted: 7/10/2008
Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 10 Jul 2008 13:45:45 -0500 (CDT)
Subject: U.S. Food & Drug Administration (FDA) CBER's Proposed and Final Rules Update
You are subscribed to CBER's Proposed and Final Rules for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Applications for Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications (Federal Register)
Posted: 7/10/2008
Update: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 10 Jul 2008 14:02:28 -0500 (CDT)
Subject: FDA Data Standards Update - SPL Update - SPL Release Four
Greetings,
The FDA Data Standards Council's SPL web page (http://www.fda.gov/oc/datacouncil/spl.html) was updated the morning of Thursday, July 10, 2008, to include the following information:
2. Structured Product Labeling Implementation Guide for FDA Drug Establishment Registration and Drug Listing v1.0
3. Structured Product Labeling Validation Procedures for Drug Establishment Registration and Drug Listing v1.0
4. Instructions for using Electronic Drug Establishment Registration and Drug Listing XForms v1.0
5. SPL Release Four Schema
6. SPL Release Four Stylesheet
7. Downloadable File: Terminology for Drug Establishment Registration and Drug Listing and Content of Labeling (XML format)
8. Document types including content of labeling document types
9. Business operations
The layout of the web page was also reorganized.
The web page will be updated later today to include the additional section headings and terms
1. Content of labeling sections
2. Route of administration
Lonnie Smith
Project Manager
Structured Product Labeling Team
Medical Informatics Staff &
FDA Data Standards Council
Update: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 10 Jul 2008 14:12:19 -0500 (CDT)
Subject: FDA MedWatch - FDA MedWatch - Herceptin 440mg Vials & BWFI Diluent-Complaints Of Damaged And Broken Vials That May Lead To A Loss Of Sterility
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Genentech informed healthcare professionals that an increased number of complaints were received regarding damaged and broken vials of Herceptin 440 mg and BWFI (bacteriostatic water for injection) diluent. The affected vials are NDC# 50242-0134-68, List # 15534. There is a risk that damaged vials may lead to a loss in sterility, which can cause infections in patients.
Healthcare professionals should inspect cartons of the product for signs of leakage, cracks and other damage to the vials, observe the vials during reconstitution, and check for loss of vacuum in the vials. See the manufacturer's letter for specific details and recommendations, including instructions in the event a compromised vial is discovered.
Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's Dear Healthcare Professional Letter regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Herceptin
Update: 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 10 Jul 2008 15:08:46 -0500 (CDT)
Subject: FDA MedWatch - May 2008 Drug Safety-Related Labeling Changes for 56 Drugs Now Available on Web
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The May 2008 posting includes 56 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and PATIENT PACKAGE INSERTS, and MEDICATION GUIDES.
The Summary Page provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/medwatch/SAFETY/2008/may08_quickview.htm
The Detailed View Page identifies safety labeling sections and subsections revised along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:
http://www.fda.gov/medwatch/SAFETY/2008/may08.htm
In May 2008, the following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:
Definity (perflutren lipid microsphere) Injectable Suspension
Ambien (zolpidem tartrate) Tablets
Ceftriaxone for Injection and Dextrose Injection
Mirena (levonorgestrel-releasing intrauterine system)
Noxafil (posaconazole) Oral Suspension
Valium (diazepam) Tablets
Accolate (zafirlukast) Tablet, Film Coated
Caduet (amlodipine besylate/atorvastatin calcium) Tablets
CellCept (mycophenolate mofetil capsules), (mycophenolate mofetil tablets)
CellCept Oral Suspension (mycophenolate mofetil for oral suspension)
CellCept Intravenous (mycophenolate mofetil hydrochloride for injection)
Chantix (varenicline) Tablets
Furadantin (nitrofurantoin) Oral Suspension
Hepsera (adefovir dipivoxil) Tablets
Herceptin (trastuzumab) Intravenous Infusion
Intron A (interferon alfa-2b, recombinant) for Injection
Keflex (cephalexin) Capsules
Keppra (levetiracetam) Injection for Intravenous Use
Levaquin (levofloxacin) Tablets and Oral Solution
Levaquin (levofloxacin) Injection, for Intravenous Use
Levaquin (levofloxacin in 5% dextrose) Injection, for Intravenous Use
Mycobutin (rifabutin capsules, USP)
Myfortic (mycophenolic acid) Delayed-Release Tablets
Primaxin I.M. (imipenem and cilastatin for injectable suspension)
Primaxin I.V. (imipenem and cilastatin) for Injection
Strattera (atomoxetine hydrochloride) Capsules
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