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FACTBOX: Drugs on U.S. FDA list for possible risks

Fri Sep 5, 2008 2:06pm EDT
 
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(Reuters) - The U.S. Food and Drug Administration on Friday began issuing a list of drugs undergoing safety probes after the agency received reports of health problems.

Appearance on the list does not mean the FDA has concluded the drug caused the problem. The agency plans to update the list quarterly.

The following drugs were identified by the FDA for the January to March period:

*Pfizer Inc's R-Gene 10 (arginine hydrochloride injection), which stimulates the pituitary gland to release human growth hormone, for reports of pediatric overdose due to labeling and packaging confusion

*Baxter International Inc's anesthesia drug Suprane (desflurane) for reports of cardiac arrest

*Eli Lilly's antidepressant Cymbalta (duloxetine) for reports of urinary retention

*Privately-held Tibotec Inc's HIV drug Intelence (etravirine) for reports of hemarthrosis, a condition characterized by blood in the joint

*Sanofi-Aventis SA's skin lesion cream Carac (fluorouracil) and privately-held JSJ Pharmaceutical's skin fungal infection and dermatitis cream Kuric (ketoconazole) for reports of adverse events due to name confusion

*Blood thinner heparin, made by Baxter, for reports of anaphylactic-type reactions

*Baxter's dialysis solution Extraneal (icodextrin) for reports of low blood sugar, also known as hypoglycemia

*Eli Lilly's diabetes therapy Humulin R (insulin U-500) for reports of dosing confusion

*Merck's anti-parasite treatment Stromectol (ivermectin) and blood thinner warfarin over reports of drug interactions

*GlaxoSmithKline's cancer drug Tykerb (lapatinib) for reports of liver toxicity

*Celgene Corp's blood cancer drug Revlimid (lenalidomide) for reports of the skin disorder Stevens Johnson Syndrome

*Biogen Idec and Elan Corp's multiple sclerosis drug Tysabri (natalizumab) for reports of skin cancer

*Pfizer's chest pain drug Nitrostat (nitroglycerin) for overdose due to reports of labeling confusion  Continued...

 

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