Thursday, July 10, 2008
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FDA May 2008 Drug Safety-Related Labeling Changes
The May 2008 posting includes 56 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and PATIENT PACKAGE INSERTS, and MEDICATION GUIDES.

The Summary Page provides a listing of drug names and safety labeling sections revised:

http://www.fda.gov/medwatch/SAFETY/2008/may08_quickview.htm

The Detailed View Page 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:

http://www.fda.gov/medwatch/SAFETY/2008/may08.htm

In May 2008, the following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:

Definity (perflutren lipid microsphere) Injectable Suspension

Ambien (zolpidem tartrate) Tablets

Ceftriaxone for Injection and Dextrose Injection

Mirena (levonorgestrel-releasing intrauterine system)

Noxafil (posaconazole) Oral Suspension

Valium (diazepam) Tablets

Accolate (zafirlukast) Tablet, Film Coated

Caduet (amlodipine besylate/atorvastatin calcium) Tablets

CellCept (mycophenolate mofetil capsules), (mycophenolate mofetil tablets)

CellCept Oral Suspension (mycophenolate mofetil for oral suspension)

CellCept Intravenous (mycophenolate mofetil hydrochloride for injection)

Chantix (varenicline) Tablets

Furadantin (nitrofurantoin) Oral Suspension

Hepsera (adefovir dipivoxil) Tablets

Herceptin (trastuzumab) Intravenous Infusion

Intron A (interferon alfa-2b, recombinant) for Injection

Keflex (cephalexin) Capsules

Keppra (levetiracetam) Injection for Intravenous Use

Levaquin (levofloxacin) Tablets and Oral Solution

Levaquin (levofloxacin) Injection, for Intravenous Use

Levaquin (levofloxacin in 5% dextrose) Injection, for Intravenous Use

Mycobutin (rifabutin capsules, USP)

Myfortic (mycophenolic acid) Delayed-Release Tablets

Primaxin I.M. (imipenem and cilastatin for injectable suspension)

Primaxin I.V. (imipenem and cilastatin) for Injection

Strattera (atomoxetine hydrochloride) Capsules

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