April 2010 Drug Safety Labeling Changes: 44 Medical Product Labels with changes to Boxed Warning, Warnings, Contraindications, Precautions, Adverse Re

The MedWatch March 2010 Drug Safety Labeling Changes posting includes 44 products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.
The "Summary Page" provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm209165.htm

Clicking on a drug product name in the Summary View will take you to the "detailed view" page, which 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.

The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and WARNINGS sections:
Propylthiouracil tablets
Aptivus (tipranavir)
Crixivan (indinavir sulfate)
Invirase (saquinavir mesylate)
Kaletra (lopinavir/ritonavir)
Lexiva (fosamprenavir calcium)
Prezista (darunavir)
Reyataz (atazanavir)
Viracept (nelfinavir mesylate)
Acephen (acetaminophen)
FeverAll (acetaminophen)
Ortho Evra (norelgestromin/ethinyl estradiol)
Rapamune (sirolimus)
Sandimmune (cyclosporine)
Tarceva (erlotinib)
Tisseel (Fibrin Sealant)
Uroxatral (alfuzosin HCl)
Valtrex (valacyclovir hydrochloride)
Ventavis (iloprost)
Vytorin (ezetimibe/simvastatin)
Yasmin (drospirenone 3 mg/ethinyl estradiol 0.03 mg)
Yaz (drospirenone 3 mg/ethinyl estradiol 0.02 mg)
Zocor (simvastatin)
Zonegran (zonisamide)
Zyprexa Relprevv (olanzapine)

open here to see the related documents:
April 2010