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Report for October
Modification List:
The following drugs had modifications to the CONTRAINDICATIONS and/or WARNINGS/BOXED WARNINGS sections:
Flovent Rotadisk (fluticasone propionate inhalation powder)
Genotropin (somatropin [rDNA origin] for injection)
Orap (pimozide) Tablets
Thalomid (thalidomide) Capsules
Accupril (quinapril hydrochloride) Tablets
Accuretic (quinapril hydrochloride/hydrochlorothiazide) Tablets
Aceon (perindopril erbumine) Tablets
Advil Cold and Sinus Caplets(ibuprofen/pseudoephedrine HCl) Tablets
Amerge (naratriptan) Tablets
Avelox (moxifloxacin hydrochloride) Tablets and I.V.
DepoCyt (cytarabine liposome injection)
Enbrel (etanercept)
Herceptin (trastuzumab)
Lotensin (benazepril HCl) Tablets
Lotensin HCT (benazepril HCl and hydrochlorothiazide) Tablets
Micardis (telmisartan) Tablets
Monopril (fosinopril sodium) Tablets
Monopril-HCT (fosinopril sodium/hydrochloride) Tablets
Permax (pergolide mesylate) Tablets
Rapamune (sirolimus) Oral Solution and Tablets
Rebetol (ribavirin) Capsules and Oral Solution
Sublimaze (fentanyl citrate) Injection
Tenoretic (atenolol and chlorthalidone) Tablets
Uniretic (moexipril hydrochloride/hydrochlorothiazide) Tablets
Univasc (moexipril hydrochloride) Tablets
Full reporting information is available at the following link:
The Summary page --
http://www.fda.gov/medwatch/SAFETY/2003/oct03_quickview.htm
-- provides drug names and a listing of the sections changed.
The Detailed view --
http://www.fda.gov/medwatch/SAFETY/2003/oct03.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.
Disclaimer: The Alpha 1 Advocacy Alliance supplies the reader with the above information and does not endorse or receive any goods or services for reporting this information.
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