FACTBOX: Drugs on U.S. FDA list for possible risks
(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
*Novartis metabolic disorder therapy Sandostatin LAR (octreotide acetate depot) for reports of ileus, an interruption of bowel propulsion
*Privately-held Purdue Pharma LP's narcotic pain drug OxyContin (oxycodone hydrochloride controlled-release) over drug misuse, abuse and overdose
*Privately-held Lantheus Medical Imaging's imaging contrast agent Definity (Perflutren Lipid Microsphere) for reports of cardiopulmonary reactions
*Pfizer's anti-seizure drug Dilantin (phenytoin injection) for reports of purple glove syndrome, a condition characterized by discoloration and pain in limb
*AstraZeneca bipolar and schizophrenia therapy Seroquel (quetiapine) for overdose due to sample pack labeling confusion
*Novartis and Idenix Pharmaceuticals Inc's hepatitis B treatment Tyzeka (telbivudine) for reports of damage to the nervous system known as peripheral neuropathy
*TNF blockers for reports of cancers in children and young adults. Tumor necrosis factor blockers include Johnson and Johnson's Remicade, Abbott Laboratories Inc's Humira, UCB SA's Cimzia, and Amgen Inc and Wyeth's Enbrel. The drugs are approved to treat rheumatoid arthritis, Crohn's disease, and other conditions.
(Reporting by Susan Heavey; Editing by Tim Dobbyn)
