DRUG RECALLS: SEPTEMBER 2010
SEPTEMBER 2010: VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) AN ANTIVIRAL MEDICATION THAT CAN BE EFFECTIVE FOR THE PREVENTION OF CYTOMEGALOVIRUS (CMV) DISEASE IN CHILDREN 4 MONTHS TO 16 YEARS OF AGE WHO HAVE AN UNDERGONE A KIDNEY OR HEART TRANSPLANT. CYTOMEGALOVIRUS IS A MEMBER OF A GROUP OF HERPES-TYPE VIRUSES THAT CAN CAUSE DISEASE IN DIFFERENT PARS OF THE BODY. RECALLED DUE TO LABEL CHANGE: POSSIBLE OVERDOSE IN PEDIATRIC PATIENTS
SEPTEMBER 2010: ACTOS (PIOGLITAZONE) RECALLED DUE TO ONGOING SAFETY REVIEW: POSSIBLE POTENTIAL INCREASED RISK OF BLADDER CANCER. AGENCY IS REVIEWING DATA TO EVALUATE IF ACTOS IS ASSOCIATED WITH INCREASED OF BLADDER CANCER, STUDIES FROM ANIMALS AND HUMANS SUGGEST THIS NEEDS FURTHER STUDY. REVIEW IS ONGOING
SEPTEMBER 2010: AROMATASE INHIBITORS IN PRODUCTS MARKETED AS DIETARY SUPPLEMENTS RECALLED DUE TO ADVERSE EFFECTS ASSOCIATED WITH THE USE OF AROMATASE INHIBITORS COULD INCLUDE DECREASED RATE OF BONE MATURATION AND GROWTH, DECREASED SPERM PRODUCTION, INFERTILITY, AGGRESSIVE BEHAVIOR, ADRENAL INSUFFICIENCY, KIDNEY FAILURE, AND LIVER DYSFUNCTION
SEPTEMBER 2010: SIMILAC POWDER INFANT FORMULA RECALLED DUE TO POSSIBILITY OF THE PRESENCE OF A SMALL COMMON BEETLE IN THE PRODUCT. INFANTS COULD POSSIBLY EXPERIENCE SYMPTOMS OF GASTROINTESTINAL DISCOMFORT AND REFUSAL TO EAT
SEPTEMBER 2010: AVANDIA (ROSIGLITAZONE) DIABETES TYPE 2 DRUG RECALLED DUE TO RISK OF CARDIOVASCULAR EVENTS SUCH AS HEART ATTACK OR STROKE
SEPTEMBER 2010: EPOGEN AND PROCRIT (EPOETIN ALFA) TREATMENT FOR ANEMIA RECALLED DUE TO THE VIALS THAT MAY CONTAIN EXTREMELY THIN GLASS FLAKES (LAMELLAE) THAT ARE BARELY VISIBLE. ADVERSE EFFECTS INCLUDE EMBOLIC, THROMBOTIC, AND VASCULAR EVENTS
SEPTEMBER 2010: OCTAGAM (IMMUNE GLOBULIN INTRAVENOUS <HUMAN>) 5% LIQUID PREPARATION RECALLED DUE TO RISK OF THROMBOEMBOLIC EVENTS
