DRUG RECALLS: MARCH 2011

 

MARCH 2011: ABACAVIR RECALL DUE TO POSSIBLE INCREASE RISK OF HEART ATTACK (ONGOING SAFETY REVIEW) 

MARCH 2011: PROTON PUMP INHIBITOR DRUGS MAY CAUSE LOW SERUM MAGNESIUM LEVELS (HYPOMAGNESEMIA) IF TAKEN PROLONGED PERIODS OF TIME (IN SOME CASES LONGER THAN A YEAR). LOW LEVELS OF SERUM MAGNESIUM CAN CAUSE SERIOUS ADVERSE EVENTS SUCH AS MUSCLE SPASMS (TETANY), IRREGULAR HEARTBEATS (ARRHYTHMIAS), AND CONVULSIONS (SEIZURES).

MARCH 2011: FDA IS PLANNING TO REMOVE CERTAIN UNAPPROVED PRESCRIPTION COUGH, COLD, AND ALLERGY DRUG PRODUCTS FROM THE U.S MARKET BECAUSE IT HAS NOT BEEN EVALUATED BY THE FDA FOR SAFETY, EFFECTIVENESS, AND QUALITY.

MARCH 2011: TOPAMAX (TOPIRAMATE) LABEL CHANGE THAT DESCRIBES THE RISK FOR DEVELOPMENT OF CLEFT LIP AND/OR CLEFT PALATE (ORAL CLEFTS) IN NEWBORNS BORN TO WOMEN TREATED WITH TOPAMAX DURING PREGNANCY. THIS DRUG WAS PLACED IN THE PREGNANCY CATEGORY D MEANING THERE IS POSITIVE EVIDENCE OF HUMAN FETAL RISK BASED ON HUMAN DATA.

MARCH 2011: KALETRA (LOPINAVIR/RITONAVIR) ORAL SOLUTION LABEL CHANGED STATING THAT SERIOUS HEALTH PROBLEMS CAN OCCUR IN PREMATURE BABIES BECAUSE THEY HAVE A DECREASED RISK ABILITY TO ELIMINATE PROPYLENE GLYCOL THAT COULD LEAD TO ADVERSE EVENTS SUCH AS SERIOUS HEART, KIDNEY, OR BREATHING PROBLEMS.

MARCH 2011: CITALOPRAM USED TO TREAT DEPRESSION RECALLED DUE TO POSSIBLY CONTAINING FINASTERIDE (TREATMENT FOR PROSTATIC HYPERPLASIA). WOMEN WHO ARE PREGNANT OR BECOME PREGNANT SHOULD NOT TAKE THIS MEDICATION DUE TO POSSIBLE RISK OF SIDE EFFECTS THAT MAY CAUSE ABNORMALITIES TO THE EXTERNAL GENITATLIA OF A DEVELOPING MALE FETUS.

MARCH 2011: 5 LOTS OF IRINOTECAN HYDROCHLORIDE INJECTION DUE TO FUNGAL MICROBIAL CONTAMINATE. NON-STERILITY OF CHEMOTHERAPUETIC PRODUCT ADMINISTERED VIA THE INTRAVENOUS ROUTE HAS THE POTENTIAL TO RESULT IN INFECTIONS WHICH COULD BE FATAL.

MARCH 2011: SOLADEK VITAMIN SOLUTION RECALLED DUE TO UNAPPROVED PRODUCT MAY CONTAIN DANGEROUSLY HIGH LEVELS OF VITAMINS A AND D. SYMPTOMS OF VITAMIN A TOXICITY MAY INCLUDE ANEMIA, ANOREXIA, ALOPECIA, JOINT PAIN, BONE WEAKNESS, BULGING EYES, LIVER ABNORMALITIES, AND BIRTH DEFECTS. SYMPTOMS OF VITAMIN D TOXICITY MAY INCLUDE WEAKNESS, FATIGUE, HEADACHES, NAUSEA, VOMITTING, DIARRHEA, CHANGES IN MENTAL STATUS, INCREASED BLOOD PRESSURE, ABNORMAL HEART RATE OR RHYTHM, KIDNEY DAMAGE AND COMA.

MARCH 2011: X-HERO/MALE ENHANCER RECALLED DUE TO UNDECLARED DRUG INGREDIENT SULFOSILDENAFIL, THE ACTIVE INGREDIENT OF FDA DRUG APPROVED USED TO TREAT ERECTILE DYSFUNCTION (ED) MAKING X-HERO AN UNAPPROVED DRUG. MALE ENHANCER FOUND INGREDIENT TADALAFIL ALSO AN ACTIVE INGREDIENT OF AN FDA DRUG APPROVED PRODUCT USED FOR ERECTILE DYSFUNCTION (ED) MAKING MALE ENHANCER AN UNAPPROVED DRUG. THIS CAN BE A THREAT BECAUSE THESE DRUGS MAY INTERACT WITH OTHER NITRATES SUCH AS NITROGLYCERIN AND MAY LOWER BLOOD PRESSURE DANGEROUSLY.

MARCH 2011: BLOOD THINNER PRADAXA (DABIGATRAN ETEXILATE MESYLATE) CAPSULES SPECIAL STORAGE AND HANDLING REQUIREMENTS AS BEEN UPDATED. DUE TO THE POTENTIAL OF PRODUCT BREAKDOWN FROM MOISTURE AND LOSS OF POTENCY, PRADAXA CAPSULES SHOULD ONLY BE STORED AND DISPENSED IN THE ORIGINAL BOTTLE OR BLISTER PACK.