From: CDER MEDWATCH LISTSERV <[EMAIL PROTECTED]>
To: [EMAIL PROTECTED]
Sent: Tuesday, May 16, 2006 9:02:20 AM
Subject: FDA MedWatch - February 2006 Safety Labeling Changes Posted
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Safety-related drug labeling changes for February 2006 have been posted
on the MedWatch website. The February 2006 posting includes 42 drug
products with safety labeling changes to the BOXED WARNING,
CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, or ADVERSE REACTIONS sections.
The Summary page --
http://www.fda.gov/medwatch/SAFETY/2006/feb06_quickview.htm
-- provides drug names and a listing of the sections changed.
The Detailed view -- http://www.fda.gov/medwatch/SAFETY/2006/feb06.htm
-- includes sections/subsections changed and a description of new or
modified safety information in the Boxed Warning, Contraindications, or
Warnings sections. The full labeling may be accessed by clicking on the
drug name in the detailed view.
The following drugs had modifications to the BOXED WARNING,
CONTRAINDICATIONS and/or WARNINGS sections:
Abilify (aripiprazole) Tablets and Oral Solution
Fortamet (metformin HCl extended-release tablets)
Tasmar (tolcapone) Tablets
Tolectin 600 (tolmetin sodium) Tablets
Tolectin DS (tolemetin sodium) Capsules
Wellbutrin (bupropion hydrochloride) Tablets
Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets
Wellbutrin XL (bupropion hydrochloride extended-release tablets)
Zyprexa (olanzapine tablets)
Zyprexa Zydis (olanzapine orally disintegrating tablets)
Zyprexa IntraMuscular (olanzapine for injection)
Paxil (paroxetine hydrochloride) Tablets and Oral Suspension
Paxil CR (paroxetine hydrochloride) Controlled-Release Tablets
Acetadote (acetylcysteine) Injection (for Intravenous Use)
Advil Allergy Sinus (200 mg ibuprofen/30 mg pseudoephedrine HCl/ 2 mg
chlorpheniramine maleate) Tablets
Advil Cold & Sinus (200 mg ibuprofen/30 mg pseudoephedrine HCl) Tablets
Advil Liqui-Gels (200 mg ibuprofen capsules)
Advil Migraine (200 mg ibuprofen) Capsules
Children's Motrin (50 mg ibuprofen) Chewable Tablets
Motrin Junior Strength (100 mg ibuprofen) Chewable Tablets
Effexor (venlafaxine hydrochloride) Tablets
Effexor XR (venlafaxine hydrochloride) Extended-Release Capsules
Junior Strength Motrin (100 mg ibuprofen) Tablets
Motrin Cold & Sinus (200 mg ibuprofen/30 mg pseudoephedrine HCl) Tablets
Motrin IB (200 mg ibuprofen) Tablets
Motrin Migraine Pain (200 mg ibuprofen) Tablets
Motrin Infants' Drops (50 mg/1.25 mL ibuprofen oral suspension)
Rituxan (rituximab) [Diffuse large B-cell, CD20-positive, non-Hodgkin's
lymphoma indication]
Rituxan (rituximab) [Rheumatoid Arthritis Indication]
_________________________________________________________________
Thank you for using FDA MedWatch as a trusted source for timely safety information on drugs, devices and diagnostics regulated by the U.S. Food and Drug Administration. If you find this e-mail notification helpful, please consider telling colleagues and friends about MedWatch and this e-mail notification process. They can learn more and subscribe to the e-list at http://www.fda.gov/medwatch.
To send a comment or question to the MedWatch program: http://www.fda.gov/medwatch/feedback.htm
To unsubscribe from this listserve:
https://list.nih.gov/cgi-bin/wa?SUBED1=medwatch&A=1
Safety-related drug labeling changes for February 2006 have been posted
on the MedWatch website. The February 2006 posting includes 42 drug
products with safety labeling changes to the BOXED WARNING,
CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, or ADVERSE REACTIONS sections.
The Summary page --
http://www.fda.gov/medwatch/SAFETY/2006/feb06_quickview.htm
-- provides drug names and a listing of the sections changed.
The Detailed view -- http://www.fda.gov/medwatch/SAFETY/2006/feb06.htm
-- includes sections/subsections changed and a description of new or
modified safety information in the Boxed Warning, Contraindications, or
Warnings sections. The full labeling may be accessed by clicking on the
drug name in the detailed view.
The following drugs had modifications to the BOXED WARNING,
CONTRAINDICATIONS and/or WARNINGS sections:
Abilify (aripiprazole) Tablets and Oral Solution
Fortamet (metformin HCl extended-release tablets)
Tasmar (tolcapone) Tablets
Tolectin 600 (tolmetin sodium) Tablets
Tolectin DS (tolemetin sodium) Capsules
Wellbutrin (bupropion hydrochloride) Tablets
Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets
Wellbutrin XL (bupropion hydrochloride extended-release tablets)
Zyprexa (olanzapine tablets)
Zyprexa Zydis (olanzapine orally disintegrating tablets)
Zyprexa IntraMuscular (olanzapine for injection)
Paxil (paroxetine hydrochloride) Tablets and Oral Suspension
Paxil CR (paroxetine hydrochloride) Controlled-Release Tablets
Acetadote (acetylcysteine) Injection (for Intravenous Use)
Advil Allergy Sinus (200 mg ibuprofen/30 mg pseudoephedrine HCl/ 2 mg
chlorpheniramine maleate) Tablets
Advil Cold & Sinus (200 mg ibuprofen/30 mg pseudoephedrine HCl) Tablets
Advil Liqui-Gels (200 mg ibuprofen capsules)
Advil Migraine (200 mg ibuprofen) Capsules
Children's Motrin (50 mg ibuprofen) Chewable Tablets
Motrin Junior Strength (100 mg ibuprofen) Chewable Tablets
Effexor (venlafaxine hydrochloride) Tablets
Effexor XR (venlafaxine hydrochloride) Extended-Release Capsules
Junior Strength Motrin (100 mg ibuprofen) Tablets
Motrin Cold & Sinus (200 mg ibuprofen/30 mg pseudoephedrine HCl) Tablets
Motrin IB (200 mg ibuprofen) Tablets
Motrin Migraine Pain (200 mg ibuprofen) Tablets
Motrin Infants' Drops (50 mg/1.25 mL ibuprofen oral suspension)
Rituxan (rituximab) [Diffuse large B-cell, CD20-positive, non-Hodgkin's
lymphoma indication]
Rituxan (rituximab) [Rheumatoid Arthritis Indication]
_________________________________________________________________
Thank you for using FDA MedWatch as a trusted source for timely safety information on drugs, devices and diagnostics regulated by the U.S. Food and Drug Administration. If you find this e-mail notification helpful, please consider telling colleagues and friends about MedWatch and this e-mail notification process. They can learn more and subscribe to the e-list at http://www.fda.gov/medwatch.
To send a comment or question to the MedWatch program: http://www.fda.gov/medwatch/feedback.htm
To unsubscribe from this listserve:
https://list.nih.gov/cgi-bin/wa?SUBED1=medwatch&A=1
Sharon --from Arizona TM 1997 to MS 1998
It's not easy taking my problems one at a time when they refuse to get in line. ~Ashleigh Brilliant
__________________________________________________
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