FDA MedWatch – April 2010 – Drug Safety Labeling Changes

The MedWatch April 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)

FDA MedWatch – November 2009 Drug Safety Labeling Changes

The MedWatch November 2009 Drug Safety Labeling Changes posting includes 44 drug 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/ucm191946.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:
• Actiq (fentanyl citrate)
• Adenocard (adenosine)
• Adenoscan (adenosine)
• Avandaryl (rosiglitazone maleate and glimepiride)
• Byetta (exenatide)
• Cimzia (certolizumab pegol)
• Cleocin HCL (clindamycin hydrochloride)
• Enbrel (etanercept)
• Humira (adalimumab)
• Lotensin (benazepril hydrochloride)
• Lotensin HCT (benazepril/hydrochlorothiazide)
• Lopressor (metoprolol tartrate)
• Norvir (ritonavir) capsule and solution
• Parnate (tranylcypromine sulfate)
• Plavix (clopidogrel bisulfate)
• Qualaquin (quinine sulfate)
• Rebetol (ribavirin), Soma (carisoprodol)
• Remicade (infliximab)
• Simponi (golimumab)
• Soma Compound (carisoprodol 200 mg and aspirin 325 mg)
• Soma Compound with Codeine (carisoprodol 200 mg, aspirin 325 mg and codeine phosphate 16 mg)
• Tekturna (aliskiren)