DRUG RECALLS: JUNE 2011
JUNE 2011: SIMPLYTHICK (a thickening agent for management for swallowing disorders, to infants born before 37 weeks gestation). THIS PRODUCT MAY CAUSE NECTROTIZING ENTEROCOLITIS (NEC) A LIFE THREATNING CONDITION CHARACTERIZED BY INFLAMMATION AND DEATH OF INTESTINAL TISSUE.
JUNE 2011: ANGIOTENSIN RECEPTORS BLOCKERS (ARBs) DRUG SAFETY REVIEW COMPLETED. NO SIGNS OF AN INCREASED INCIDENT (NEW) CANCER, CANCER-RELATED DEATH, BREAST CANCER, LUNG CANCER, OR PROSTATE CANCER IN PATIENTS WHO TAKE ARBs.
JUNE 2011: FDA NOTIFIED HEALTHCARE PROFESSIONALS THAT IT IS RECOMMENDED TO LIMIT THE USE OF HIGH APPROVED DOSE OF THE CHOLESTEROL-LOWERING MEDICATION SIMVASTATIN (80MG) DAILY BECAUSE OF THE INCREASED RISK OF MUSCLE DAMAGE. PATIENTS TAKING SIMAVASTATIN (80MG) DAILY HAVE AN INCREASED RISK OF MYOPATHY COMPARED TO PATIENTS TAKING LOWER DOSES OF THIS DRUG OR OTHER DRUGS IN THE SAME CLASS. THE RISK SEEMS TO BE HIGHER DURING THE FIRST YEAR OF TREATMENT, IT IS OFTEN THE RESULT OF INTERACTIONS WITH CERTAIN MEDICATIONS, AND IS FREQUENTLY ASSOCIATED WITH A GENETIC PREDISPOSITION TOWARDS SIMVASTATIN-RELATED MYOPATHY. THE MOST SERIOUS FORM OF MYOPATHY, CALLED RABDOMYOLYSIS, CAN DAMAGE THE KIDNEYS AND LEAD TO KIDNEY FAILURE WHICH CAN BE FATAL. FDA IS REQUIRING CHANGES TO THE SIMVASTATIN LABEL TO ADD MORE CONTRAINDICATIONS (should not be used with certain medications) AND DOSE LIMITATIONS FOR USING SIMVASTATIN WITH CERTAIN MEDICINES.
JUNE 2011: 5 APLHA-REDUCTASE INHIBITORS (5-ARIs)LABEL HAS CHANGED. THESE CLASS OF DRUGS HAS BEEN REVISED TO INCLUDE NEW SAFETY INFORMATION ABOUT THE INCREASED RISK OF BEING DIAGNOSED WITH A MORE SERIOUS FORM OF PROSTATE CANCER.
JUNE 2011: DIABETES MEDICATION ACTOS (PIOGLITAZONE)HAS AN ONGOING SAFETY REVIEW STATING INCREASED RISK OF BLADDER CANCER. SINCE THIS HAS BEEN ONGOING FOR MORE THAN A YEAR IT IS NOW GOING TO BE LABELED IN THE MEDICATION WARNINGS AND PRECAUTIONS SECTION.
JUNE 2011: INDOMETHACIN FOR INJECTION, USP,1MG SINGLE DOSE VIAL (NDC #55390-299-01, LOT 1948138, EXP.DATE SEPTEMBER 2011)INDICATED TO CLOSE A HEMODYNAMICALLY SIGNIFICANT PATENT DUCTUS ARTERIOSUS IN PREMATURE INFANTS, WHO TYPICALLY HAVE SMALL BLOOD VESSELS, HAS BEEN RECALLED DUE TO PARTICULATE MATTER. PARTICULATE MATTER HAS BEEN IDENTIFIED AS AN ACTIVE DRUG SUBSTANCE AND NOT FOREIGN MATERIAL OR CONTAMINATION. PATICULATE MATTER MAY PROVOKE AN IMMUNE REACTION OR LEAD TO MICROINFARCTS WHICH COULD BE SERIOUS AND LIFE THREATNING.
JUNE 2011: CHANTIX (VARENICLINE)LABEL HAS BEEN CHANGED STATING THAT THE DRUG HAS CERTAIN RISKS OF CARDIOVASCULAR ADVERSE EVENTS IN PATIENTS WHO HAVE CARDIOVASCULAR DISEASE. THIS SAFETY INFORMATION WILL BE ADDED IN THE WARNING AND PRECAUTIONS SECTION ALSO WILL BE ADDED IN THE PATIENT MEDICATION GUIDE.
JUNE 2011: SCHIZOPHRENIA DRUG NAMED RISPERDAL(RISPERIDONE)2MG & 3MG OF SPECIFIC LOTS RECALLED DUE TO AN UNCHARACTERISTIC ODOR THOUGHT TO BE CAUSED BY TRACE AMOUNTS OF TBA (2,4,6 TRIBROMOANISOLE). TBA IS A BYPRODUCT OF A CHEMICAL PRESERVATIVE SOMETIMES APPLIED TO WOOD OFTEN USED IN THE CONTRUCTION OF PALLETS ON WHICH MATERIALS ARE TRANSPORTED OR STORED. WHILE TBA NOT CONSIDERED TO BE TOXIC, TBA CAN GENERATE AN OFFENSIVE ODOR AND A SMALL NUMBER OF PATIENTS HAVE REPORTED TEMPORARY GARTROINTESTINAL SYMPTOMS.
JUNE 2011: BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLETS (USP 50mg, 325mg, 40mg) AND HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS (USP 7.5mg, 500mg): RECALLED DUE TO BOTTLE MISLABELED. POSSIBLY CONTAINING INCORRECT TABLETS, AND PATIENTS MAY UNINTENTIONALLY TAKE BUTALBITAL AND CAFFEINE INSTEAD OF HYDROCODONE. THIS ACTION COULD LEAD TO SYMPTOMS SUCH AS SADATION, LIGHTHEADEDNESS, DIZZINESS, AND NAUSEA. PATIENTS WHO ARE ALLERGIC TO BUTALBITAL COULD EXPERIENCE A HYPERSENSITIVITY REACTION. THOSE INDIVIDUALS WITH SENSITIVITY TO CAFFEINE MAY EXPERIENCE SYMPTOMS SUCH AS TREMORS, IRRITABILITY, AND DIFFICULTY SLEEPING. PATIENTS WHO WERE TAKING HYDROCODONE FOR CHRONIC PAIN MAY EXPERIENCE WORSENING PAIN AND WITHDRAWAL SYMPTOMS AS A RESULT OF THIS SUBSTITUTION.
JUNE 2011: ENDOCET (OXYCODONE / ACETAMINOPHEN) TABLETS 10MG & 325MG RECALLED DUE TO SOME BOTTLES CONTAINING DIFFERENT STRENGTH TABLETS RESULTING IN PATIENTS TAKING MORE THAN THE INTENDED ACETAMINOPHEN DOSE. THIS ACTION MAY RESULT IN LIVER TOXICITY, ESPECILLAY IN PATIENTS TAKING OTHER ACETAMINOPHEN CONTAINING MEDICATIONS, PATIENTS WITH LIVER DYSFUNCTION, OR PEOPLE WHO CONSUME MORE THAN 3 ALCOHOLIC BEVERAGES A DAY.
JUNE 2011: TYLENOL EXTRA STRENGTH CAPLETS (225 COUNT BOTTLES)RECALLED DUE TO UNCHARACTERISTIC ODOR SUCH AS MUSTY, MOLDY ODOR. THE ODOR HAS BEEN LINKED TO THE PRESENCE OF TRACE AMOUNTS OF A CHEMICAL KNOWN AS 2,4,6 TRIBROMOANISOLE (TBA). WHILE NOT CONSIDERED TO BE TOXIC, TBA CAN GENERATE AN OFFENSIVE ODOR AND HAS BEEN ASSOCIATED WITH TEMPORARY AND NON SERIOUS GASTROINTESTINAL SYMPTOMS.
JUNE 2011: NATURAL RELIEF INSTANT WART AND MOLE REMOVER RECALLED DUE TO RISK OF SEVERE SKIN BURNS PARTICULARY TO AREAS OF THIN OR SENSITIVE SKIN (FACE,AREAS AROUND THE EYE,& GENITALIA) CAUSED BY ACTIVE INGREDIENT CALCIUM OXIDE. FDA HAS RECEIVED A REPORT OF THIS BURN.
JUNE 2011: CHILDREN BORN TO MOTHERS WHO TAKE ANTI-SEIZURE MEDICATIONS SUCH AS VALPROATE SODIUM OR RELATED PRODUCTS DURING PREGNANCY HAVE AN INCREASED RISK OF LOWER COGNITIVE TEST SCORES THAN CHILDREN EXPOSED TO OTHER ANTI-SEIZURE MEDICATIONS DURING PREGNANCY. THIS CONCLUSION IS BASED ON THE RESULTS OF EPIDEMIOLOGIC STUDIES THAT SHOW THAT CHILDREN BORN TO MOTHERS WHO TOOK VALPROATE SODIUM OR RELATED PRODUCTS THROUGHOUT THEIR PREGNANCY TEND TO SCORE LOWER ON COGNITIVE TESTS (IQ OR OTHER TESTS) THAN CHILDREN BORN TO MOTHERS WHO TOOK OTHER ANTI-SEIZURE MEDICATIONS DURING PREGNANCY.
