> [Original Message] > From: CDER MEDWATCH LISTSERV <[EMAIL PROTECTED]> > To: <[EMAIL PROTECTED]> > Date: 2/7/2007 10:36:09 AM > Subject: FDA MedWatch - December 2006 Safety Labeling Changes posted on website > > MedWatch - The FDA Safety Information and Adverse Event Reporting Program > > Safety-related drug labeling changes for December 2006 were posted on > the MedWatch website. > > The December 2006 posting includes 35 drug products with safety labeling > changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, > ADVERSE REACTIONS, and PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. > > The Summary page -- > > http://www.fda.gov/medwatch/SAFETY/2006/dec06_quickview.htm > > -- provides drug names and a listing of the sections changed. > > The Detailed view -- > > http://www.fda.gov/medwatch/SAFETY/2006/dec06.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 in the detailed view. > > The following drugs had modifications to the BOXED WARNING, > CONTRAINDICATIONS, and/or WARNINGS sections: > > Activella (estradiol/norethindrone acetate) Tablets > Diskets Dispersible Tablets (methadone hydrochloride tablets, USP) > Trasylol (aprotinin injection) > Crixivan (indinavir sulfate) Capsules > Vfend I.V. (voriconazole) for Injection, Vfend (voriconazole) Tablets, > and Vfend (voriconazole) for Oral Suspension > Colazal (balsalazide disodium) Capsules > Emtriva (emtricitabine) Capsules and Oral Solution > Ibuprofen Capsules, 200 mg > Pexeva (paroxetine mesylate) Tablets > Suprane (desflurane, USP) Volatile Liquid for Inhalation > Twinject Auto-Injector (epinephrine injection, USP 1:1000) > > The following drugs had modification to patient information labeling > [either Medication Guide or Patient Package Insert]: > > Activella (estradiol/norethindrone acetate) Tablets > Crixivan (indinavir sulfate) Capsules > Vfend I.V. (voriconazole) for Injection, Vfend (voriconazole) Tablets, > and Vfend (voriconazole) for Oral Suspension > Colazal (balsalazide disodium) Capsules > Emtriva (emtricitabine) Capsules and Oral Solution > Twinject Auto-Injector (epinephrine injection, USP 1:1000) > Byetta (exenatide) Injection > Fuzeon (enfuvirtide) for Injection > Kaletra (lopinavir/ritonavir) Capsules and Oral Solution > Kaletra (lopinavir/ritonavir) Tablets and Oral Solution > Velcade (bortezomib) for Injection > Viracept (nelfinavir mesylate) Tablets and Oral Powder > Fosamax (alendronate sodium) Tablets and Oral Solution > Fosamax Plus D (alendronate sodium/cholecalciferol) Tablets > Spiriva HandiHaler (tiotropium bromide inhalation powder) for Oral > Inhalation Only > Depakote Sprinkle Capsules (divalproex sodium coated particles in > capsules) > Hyzaar (losartan potassium-hydrochlorothiazide tablets) > PegIntron (peginterferon alfa-2b) Powder for Injection > PegIntron (peginterferon alfa-2b) Redipen Single Dose Delivery 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
