FDA Adverse Event Reporting

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Safety-related drug labeling changes for May 2005 have been posted on the MedWatch website. The May 2005 posting includes 42 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/2005/may05_quickview.htm -- provides drug names and a listing of the sections changed.

The Detailed view -- http://www.fda.gov/medwatch/SAFETY/2005/may05.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:

Alora (estradiol transdermal system)
Arixtra (fondaparinux sodium) injection
Atacand (candesartan cilexetil) Tablets
Cefuroxime for Injection USP and Dextrose Injection USP
Clozaril (clozapine) Tablets Lodine (etodolac capsules and tablets)
Midol Extended Relief (220 mg naproxen sodium)
Pegasys (peginterferon alfa-2a)
Requip (ropinirole hydrochloride) Tablets
Tagamet HB (200mg cimitidine) Tablets
Zestoretic (lisinopril/hydrochlorothiazide) Tablets
Zestril (lisinopril) Tablets Zocor (simvastatin) Tablets

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