[e-farmacos] FDA: cambios por problemas de seguridad

["Madurga, Mariano" <mmadurga@agemed.es>]

Estimadas y estimados amigos, 

Transcribo mensaje de la FDA sobre las ultimas modificaciones, de febrero 2005, por problemas de seguridad en medicamentos de los EE.UU.:

MedWatch - The FDA Safety Information and Adverse Event Reporting Program 

Safety-related drug labeling changes for February 2005 have been posted on the MedWatch website. 

The February 2005 posting includes 36 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/feb05_quickview.htm 
-- provides drug names and a listing of the sections changed. The Detailed view -- 
http://www.fda.gov/medwatch/SAFETY/2005/feb05.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: 
Copegus (ribavirin, USP) Tablets  
Duragesic (fentanyl transdermal system)  
Lotronex (alosetron HCl) Tablets 
Malarone (atovaquone and proguanil hydrochloride) Tablets 
Malarone (atovaquone and proguanil hydrochloride) Pediatric Tablets 
Serostim LQ (somatropin [rDNA origin] injection)  
Celexa (citalopram hydrobromide) Tablets and Oral Solution 
Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules  
Effexor (venlafaxine hydrochloride) Tablets  
Effexor XR (venlafaxine hydrochloride) Extended-Release Capsules 
Lexapro (escitalopram oxalate) Tablets and Oral Solution 
Nardil (phenelzine sulfate tablets, USP)  
Prozac (fluoxetine hydrochloride)  
Sarafem (fluoxetine hydrochloride) 
Sinequan (doxepin HCl) Capsules and Oral Concentrate 
Symbyax (olanzapine and fluoxetine HCl capsules) 
Viramune (nevirapine) Tablets and Oral Suspension 
Zoloft (sertraline hydrochloride) Tablets and Oral Concentrate 
Atacand (candesartan cilexetil) Tablets 
Cancidas (caspofungin acetate) for Injection 
Gabitril (tiagabine hydrochloride) Tablets  
Minocin (minocycline for Injection) Intravenous 
Minocin (minocycline hydrochloride) Pellet-filled Capsules and Oral Suspension  
Strattera (atomoxetine HCl) 
Tenoretic (atenolol and chlorthalidone) 
Tenormin (atenolol) I.V. Injection 
Tenormin (atenolol) Tablets 
Zantac 75 (ranitidine) Tablets 

Thank you for using MedWatch as a trusted source for timely safety information on drugs and other medical products regulated by the U.S. Food and Drug Administration. If you find this e-mail notification helpful, please consider telling colleagues and friends about MedWatch. They can learn more about us and subscribe/unsubscribe to the e-list at the MedWatch homepage, http://www.fda.gov/medwatch or by going directly to:
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Un abrazo,

Mariano Madurga
Agencia Espanhola de Medicamentos y Productos Sanitarios