DRUG RECALLS: AUGUST 2011 

 

AUGUST 2011: IF GIVEN DIFLUCAN (FLUCONAZOLE) 400-800MG/DAY DURING THE FIRST TRIMESTER OF PREGNANCY MAY BE ASSOCIATED WITH A RARE AND DISTINCT SET OF BIRTH DEFECTS IN INFANTS. THE RISK DOES NOT APPEAR TO BE ASSOCIATED WITH A SINGLE, LOW DOSE OF FLUCONAZOLE 150MG TO TREAT VAGINAL YEAST INFECTION (CANDIDIASIS). BASED ON THE INFOMATION ABOVE THE PREGNANCY CATEGORY HAS CHANGED TO C TO D BUT PREGANANCY CATEGORY FOR A SINGLE, LOW DOSE REMAINS THE SAME WHICH IS CATEGORY C.

AUGUST 2011: VASOPRESSIN INJECTION USP, MULTIPLE DOSE VIALS HAS BEEN RECALLED DUE TO SOME VIALS MAY NOT MAINTAIN POTENCY THROUGHOUT THEIR SHELF LIFE. POTENTIAL ADVERSE EVENTS AFTER ADMINISTRATION OF SOLUTIONS THAT ARE BELOW POTENCY LIMITS MAY INCLUDE REDUCED EFFECTIVENESS.

AUGUST 2011: FDA STILL HAS ONGOING REVIEWS OF DRUG RECOMBINANT HUMAN GROWTH HORMONE (SOMATROPIN)THAT MAY POSSIBLY HAVE AN INCREASED OF DEATH. FDA RECOMMENDS TO TAKE DRUG FROM THE LABELED RECOMMENDATIONS. DRUG WILL HAVE AN ONGOING STUDY TO FIND EVIDENCE OF RISK OF DEATH.

AUGUST 2011: ANTIDEPRESSANT DRUG CELEXA (CITALOPRAM HYDROBROMIDE) SHOULD NO LONGER BE USED IN DOSES GREATER THAN 40 MG PER DAY BECAUSE IT CAN CAUSE ABNORMAL CHANGES IN THE ELECTRICAL ACTIVITY OF THE HEART. CHANGES IN THE ELECTRICAL ACTIVITY OF THE HEART CAN LEAD TO AN ABNORMAL HEART RHYTHM WHICH CAN BE FATAL.