I was asked to forward this message to the list for anybody interested: > From: CDER MEDWATCH LISTSERV <[EMAIL PROTECTED]> > To: <[EMAIL PROTECTED]> > Date: 7/17/2007 3:30:34 PM > Subject: FDA MedWatch: April 2007 Monthly Safety Labeling Changes Posted on Website > > MedWatch - The FDA Safety Information and Adverse Event Reporting Program > > The April 2007 posting includes 54 drug products with safety labeling changes to the WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and PATIENT > PACKAGE INSERT/MEDICATION GUIDE sections. > > The Summary page -- > > http://www.fda.gov/medwatch/SAFETY/2007/apr07_quickview.htm > > -- provides drug names and a listing of the sections changed. > > The Detailed view -- > > http://www.fda.gov/medwatch/SAFETY/2007/apr07.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 prescribing information link below the drug's name. > > The following drugs had modifications to the CONTRAINDICATIONS, and/or WARNINGS sections: > > Enjuvia (synthetic conjugated estrogens, B) Tablets > Fentora (fentanyl buccal tablet) > Ativan (lorazepam) Tablets > Femara (letrozole tablets) > Invirase (saquinavir mesylate) Capsules and Tablets > Advicor (niacin extended-release/lovastatin tablets) > Baraclude (entecavir) Tablets and Oral Solution > Exjade (deferasirox) Tablets for Oral Suspension > Levitra (vardenafil HCl) Tablets > Minocin (minocycline hydrochloride) Pellet-Filled Capsules > Sarafem (fluoxetine hydrochloride tablets) > Zerit (stavudine) Capsules and Zerit (stavudine) for Oral Solution > Zyvox (linezolid) Injection and Tablets and Zyvox (Iinezolid) for Oral Suspension > > The following drugs had modification to patient information labeling [either Medication Guide or Patient Package Insert]: > > Enjuvia (synthetic conjugated estrogens, B) Tablets > Fentora (fentanyl buccal tablet) > Invirase (saquinavir mesylate) Capsules and Tablets > Baraclude (entecavir) Tablets and Oral Solution > Levitra (vardenafil HCl) Tablets > Zerit (stavudine) Capsules and Zerit (stavudine) for Oral Solution > Actonel (risedronate sodium tablets) > Apidra (insulin glulisine [rDNA origin] injection) > Aranesp (darbepoetin alfa) for Injection > Focalin (dexmethylphenidate hydrochloride) Tablets > Focalin XR (dexmethylphenidate hydrochloride) Extended- Release Capsules > Fortamet (metformin hydrochloride) Extended-Release Tablets > Lantus (insulin glargine [rDNA origin] injection) > Ritalin hydrochloride (methylphenidate hydrochloride tablets, USP) > Ritalin-SR (methylphenidate hydrochloride, USP sustained-release tablets) > Ritalin LA (methylphenidate hydrochloride) Extended-Release Capsules > Singulair (montelukast sodium) Tablets, Chewable Tablets, and Oral Granules > Strattera (atomoxetine HCl) Capsules > Fosamax Plus D (alendronate sodium/cholecalciferol) Tablets > Solagé (mequinol 2%, tretinoin 0.01%) Topical Solution > EC-Naprosyn (naproxen delayed-release tablets), Naprosyn (naproxen tablets), Anaprox/Anaprox DS (naproxen sodium tablets), and > Naprosyn (naproxen suspension) > NicoDerm CQ (nicotine transdermal system) > > _________________________________________________________________ > > To ensure delivery of these timely alerts to your in-box and prevent rejection of the notice by a spam filter, please add our MedWatch address, [EMAIL PROTECTED], to your address book. > > 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 > > > -- > No virus found in this incoming message. > Checked by AVG Free Edition. > Version: 7.5.476 / Virus Database: 269.10.8/904 - Release Date: 7/16/2007 5:42 PM
