FDA MedWatch - July 2009 Drug Safety Labeling Changes - 38 drugs
 with changes to Boxed Warning, Warnings, Contraindications, Precautions,
 Adverse Reactions

The MedWatch July 2009 Drug Safety Labeling Changes posting includes 38 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/ucm172740.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:  

Chantix (varenicline), Wellbutrin (bupropion hydrochloride), Zyban (bupropion hydrochloride), Diabeta (glyburide), Lopid (gemfibrozil), Ortho Evra (norelgestromin/ethinyl estradiol) transdermal system, Veramyst (fluticasone furoate), Actonel (risedronate sodium), Gardasil (Human Papillomavirus Quadrivalent Types 6, 11, 16, 18) Recombinant Vaccine,  Letairis (ambrisentan), Myfortic (mycophenolic acid), Rilutek (riluzole), Soliris (eculizumab)




Orlistat (marketed as Alli and Xenical): FDA reviewing reports of serious liver injury, including liver failure

Orlistat (marketed as Alli and Xenical): Early Communication about an Ongoing Safety Review Audience: Endocrinological healthcare professionals, patients

FDA notified healthcare professionals and patients that it is reviewing new safety information regarding reports of liver-related adverse events in patients taking orlistat. Orlistat is marketed in the United States as a prescription product, Xenical, and as an over-the-counter (OTC) product, Alli. Between 1999 and October 2008, 32 reports of serious liver injury, including 6 cases of liver failure, in patients using orlistat were submitted to FDA
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm180025.htm