FDA MedWatch - November 2004 Safety Labeling Changes Posted

[Brian, ASN, RN]

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Safety-related drug labeling changes for November 2004 have been posted on

the MedWatch website.

The November 2004 posting includes 38 drug products with safety labeling

changes to the CONTRAINDICATIONS, BOXED WARNING, WARNINGS, PRECAUTIONS, or

ADVERSE REACTIONS sections. The Summary page --

http://www.fda.gov/medwatch/SAFETY/2004/nov04_quickview.htm

-- provides drug names and a listing of the sections changed. The Detailed

view --

http://www.fda.gov/medwatch/SAFETY/2004/nov04.htm

-- includes sections/subsections changed and a description of new or

modified safety information in the Contraindications, Boxed Warning, or

Warnings sections. The full labeling may be accessed by clicking on the drug

name in the detailed view.

The following drugs had modifications to the CONTRAINDICATIONS and/or

WARNINGS/BOXED WARNINGS sections:

Bextra (valdecoxib) Tablets

Canasa (mesalamine, USP) Rectal Suppositories

Cosmegen (dactinomycin for injection)

Depo-Provera Contraceptive Injection (medroxyprogesterone acetate injectable

suspension)

Norditropin Cartridges (somatropin [rDNA origin] injection)

Phenergan (promethazine HCl) Tablets and Suppositories

Robinul (glycopyrrolate injection, USP) Injection

Saizen (somatropin [rDNA origin] for injection)

Striant (testosterone buccal system) mucoadhesive

Tracleer (bosentan) Tablets

Altace (ramipril) Capsules

AndroGel (testosterone gel) 1%

Levaquin (levofloxacin) Tablets, Oral Solution and Injection

Levaquin (levofloxacin in 5% dextrose) Injection

Naprosyn (naproxen suspension)

Naprosyn (naproxen tablets)

EC-Naprosyn (naproxen delayed -release tablets)

Anaprox/Anaprox DS (naproxen sodium) Tablets

Remodulin (treprostinil sodium) Injection

Tabloid (thioguanine) Tablets

Zyban (bupropion hydrochloride) Sustained-Release Tablets