FDA MedWatch - October 2004 Safety Labeling Changes Posted

[Brian, ASN, RN]

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 --

http://www.fda.gov/medwatch/SAFETY/2004/oct04_quickview.htm

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

view --

http://www.fda.gov/medwatch/SAFETY/2004/oct04.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:

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

Enbrel (etanercept)

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]

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 --

http://www.fda.gov/medwatch/SAFETY/2004/oct04_quickview.htm

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

view --

http://www.fda.gov/medwatch/SAFETY/2004/oct04.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:

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

Enbrel (etanercept)

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

[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