FDA MedWatch - January 2005 safety labeling changes posted

ROCKVILLE, MD., March 14, 2005 -- Safety-related drug labeling changes for January 2005 have been posted on the MedWatch website.

The January 2005 posting includes 41 drug products with safety labeling changes to the CONTRAINDICATIONS, BOXED WARNING, WARNINGS, PRECAUTIONS, or ADVERSE REACTIONS sections. The Summary page is attached and provides drug names and a listing of the sections changed. The Detailed view is also attached and 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:

Combipatch (estradiol/norethindrone acetate transdermal system) Phenergan (promethazine hydrochloride) Tablets and Suppositories Anafranil (clomipramine hydrochloride capsules) Aventyl (nortriptyline hydrochloride) Oral Solution Desyrel (trazodone hydrochloride) Tablets Doxil (doxorubicin HCl liposome injection) Femhrt (norethindrone acetate/ethinyl estradiol tablets) Limbitrol (chlordiazepoxide and amitriptyline hydrochloride) Tablets Marplan (isocarboxazid) Tablets Norpramin (desipramine hydrochloride) Tablets Pamelor (nortriptyline HCl) Capsules and Solution, USP Parnate (tranylcypromine sulfate) Tablets Paxil (paroxetine hydrochloride) Controlled-Release Tablets Paxil (paroxetine hydrochloride) Tablets and Oral Suspension Pexeva [paroxetine (as mesylate)] Tablets Remeron SolTab (mirtazapine) Orally Disintegrating Tablets Remeron (mirtazapine) Tablets Serzone (nefazodone hydrochloride) Tablets Surmontil (trimipramine maleate) Capsules Tofranil-PM (imipramine pamoate) Capsules Wellbutrin (bupropion hydrochloride) Tablets Wellbutrin SR (bupropion hydrochloride) Wellbutrin XL (bupropion hydrochloride extended-release tablets) Zyban (bupropion hydrochloride) Sustained-Release Tablets Aranesp (darbepoetine alfa) Avastin (bevacizumab) Intron A (interferon alfa-2b, recombinant) For Injection Novamine 15% Amino Acid Injection Pharmacy Bulk Package Zometa (zoledronic acid) Injection.

Source: FDA MedWatch www.fda.gov/medwatch

Posted: March 2005


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