TELEFLEX MEDICAL ANNOUNCED THAT THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) HAS CLASSIFIED THE VOLUNTARY MEDICAL DEVICE RECALL INITIATED ON FEBRUARY 2, 2009 BY ARROW INTERNATIONAL'S CARDIAC CARE DIVISION INVOLVING VOLUME CONNECTORS FOR ITS 30CC, 40CC AND 50CC INTRA AORTIC BALLOON PUMP (IAB) CATHETERS AS A CLASS 1 RECALL. FDA DEFINES CLASS I RECALLS … [Read more...]

The fluroquinolone antibiotic Levaquin, used to treat lung, sinus, skin, and urinary tract infections caused by certain bacteria. FDA recently ordered the makers of Levaquin to include a black box warning on the drug after reports of severe Levaquin side effects related to painful tendon and ligament injuries. The Levaquin side effects resulting … [Read more...]

FDA is putting a black box warning (the strongest FDA warning) on all drugs containing the pharmaceutical ingredient metoclopramide (Reglan), which is used in the treatment of disorders like heartburn caused by gastroesophageal reflux disease. The black box label warns consumers about the risk of developing tardive dyskinesia, which causes … [Read more...]

FDA has warned healthcare professionals about the potential for patients taking the anticonvulsant (anti-seizure) drug Zonisamide to develop Metabolic Acidosis, a blood PH imbalance that can result in hyperventilation, and non-specific symptoms such as fatigue and anorexia, or more severe symptoms including cardiac arrhythmias or stupor, and can … [Read more...]