Published Dec 17, 2004
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Safety-related drug labeling changes for October 2004 have been posted on
the MedWatch website.
The October 2004 posting includes 32 drug products with safety labeling
changes to the CONTRAINDICATIONS, BOXED WARNING, WARNINGS, PRECAUTIONS, or
ADVERSE REACTIONS sections. The Summary page --
-- provides drug names and a listing of the sections changed. The Detailed
-- 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:
Lovenox (enoxaparin sodium injection)
Lupron (leuprolide acetate) Injection
Nutropin Depot (somatropin [rDNA origin] for injectable suspension)
Roferon-A (interferon alfa-2a, recombinant)
Tikosyn (dofetilide) Capsules
Vesanoid (tretinoin) Capsules
Doxil (doxorubicin HCl) Liposome Injection
Altace (ramipril) Capsules
Axid AR (nizatidine)
Concerta (methylphenidate HCl) Extended-release Tablets
Cuprimine (penicillamine) Capsules
Fuzeon (enfuvirtide) for Injection
Kaletra (lopinavir/ritonavir) Capsules and Oral Solution
Levaquin (levofloxacin) Tablets, Oral Solution and Injection
Levaquin (levofloxacin in 5% dextrose) Injection
Pepcid AC (famotidine) Chewable Tablets
Pepcid Complete (famotidine, calcium carbonate & magnesium hydroxide)
Pepcid AC (famotidine) Gelcaps
Pepcid AC (famotidine) Maximum Strength Film Coated Tablets
Pepcid AC (famotidine) Original Strength Film Coated Tablets
Wellbutrin XL (bupropion hydrochloride) Extended-Release Tablets
Brian, ASN, RN
NRSKarenRN, BSN, RN
Medical journal: Doctors say avoid Pfizer's Bextra
Doctors writing in a prominent medical journal have recommended that physicians stop prescribing Pfizer Inc.'s Bextra painkiller, just as a large study found the drugmaker's sister drug, Celebrex, doubled risk of heart attacks.
Reuters/Yahoo!, Dec. 17, 2004
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