DRUG RECALLS: JUNE 2010
JUNE 2010: NEW SAFE USE REQUIREMENT FOR LONG ACTING BETA AGONISTS BECAUSE STUDIES SHOWS AN INCREASED RISK OF SEVERE EXACERBATION OF ASTHMA SYMPTOMS LEADING TO HOSPITALIZATIONS IN ADULTS AND PEDIATRICS PATIENTS, ALSO LEADING TO DEATH WHEN USING THIS PRODUCT FOR ASTHMA
JUNE 2010: GAMMAGARD LIQUID, IMMUNE GLOBULIN INTRAVENOUS (HUMAN) RECALLED DUE TO NUMBER OF ADVERSE EVENTS REPORTS OF ALLERGIC REACTIONS
JUNE 2010: PROPOFOL INJECTABLE EMULSION 1%, LIPOSYN (INTRAVENOUS FAT EMULSION) PRODUCTS INCLUDING LIPOSYN II 10%, LIPOSYN II 20%, LIPOSYN III 10%, LIPOSYN III 20%, LIPOSYN III 30% RECALLED DUE TO SOME OF THE CONTAINERS MAY CONTAIN PARTICLE MATTER, PRIMARILY MADE UP OF SUB-VISIBLE INERT STAINLESS STEEL PARTICLES. SINCE THESE PARTICLES CONTAMINANTS DO NOT DISSOLVE IN BLOOD THEY COULD ACT AS A EMBOLI & IMPEDE BLOOD FLOW
JUNE 2010: BENICAR (OLMESARTAN) A BLOOD PRESSURE DRUG RECALLED DUE TO THE FDA REVIEW THAT IT HAD A HIGHER RISK OF DEATH FROM A CARDIOVASCULAR CAUSE COMPARED TO PATIENTS TAKING A PLACEBO. FDA REVIEW IS STILL ONGOING & THE AGENCY HAS NOT CONCLUDED THAT BENICAR INCREASES THE RISK OF DEATH
JUNE 2010: VITAMIN D SUPPLEMENT PRODUCTS WITH DROPPERS RECALLED DUE TO MEDICATION USE ERROR, IT COULD ALLOW PARENTS TO ACCIDENTLY GIVE EXCESSIVE AMOUNTS TO INFANTS
JUNE 2010: MYLOTARG (GEMTUZAMUB OZOGAMICIN) INDICATED FOR ACUTE MYELOID LEUKEMIA WAS RECALLED DUE TO CLINICAL TRIAL NEW CONCERNS ABOUT SAFETY & DRUG FAILING TO DEMONSTRATE CLINICAL BENEFITS TO PATIENTS ENROLLED IN TRIALS
JUNE 2010: MAGIC POWER COFFEE, A PRODUCT MARKETED AS DIETARY SUPPLEMENT FOR SEXUAL ENHANCEMENT THAT CONTAINS AN INGREDIENT HYDROXYTHIOHOMOSILDENAFIL, RECALLED DUE TO INTERACTIONS TOWARDS PRESCRIPTIONS DRUGS SUCH AS NITRATES INCLUDING NITROGLYCERIN AND CAUSE DANGEROUSLY LOW BLOOD PRESSURE
