The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.
June 9, 2004
PRODUCT Metacam (meloxicam) 1.5 mg/mL Oral Suspension, Non-steroidal anti-inflammatory drug for oral use in dogs only, packaged in 10-ml bottles, RX, NADA #141-213. Recall # V-131-4. CODE Lot # 113ZM71. RECALLING FIRM/MANUFACTURER Boehringer Ingelheim Vetmedica Inc., MO, by letters dated March 3, and March 25, 2004. Firm initiated recall is complete. REASON A kilogram dosing syringe was packaged with the product rather than a dosing syringe calibrated in pounds. VOLUME OF PRODUCT IN COMMERCE 65,890 packages. DISTRIBUTION TN, GA, and IA.
ALL of this information was copied directly from the FDA/CVM ADE (adverse drug event) reports and only put into alphabetical order with medical terminology definitions provided as indicated and some symptoms/conditions listed in body system category, which are underlined.
ADIPSIA - loss of thirst ; also : abnormal and especially prolonged abstinence from the intake of fluids AGGRESSION ANAPHYLAXIS/TOID - hypersensitivity (as to foreign proteins or drugs) resulting from sensitization following prior contact with the causative agent anaphylactic shock: an often severe and sometimes fatal systemic reaction in a susceptible individual upon a second exposure to a specific antigen (as wasp venom or penicillin) after previous sensitization that is characterized especially by respiratory symptoms, fainting, itching, and hives ANEMIA - a condition in which the blood is deficient in red blood cells, in hemoglobin, or in total volume -- seeAPLASTIC ANEMIA,HYPERCHROMIC ANEMIA,HYPOCHROMIC ANEMIA,MEGALOBLASTIC ANEMIA,MICROCYTIC ANEMIA,PERNICIOUS ANEMIA,SICKLE-CELL ANEMIA; compare OLIGOCYTHEMIA
ANEMIA, AUTOIMMUNE HEM - of, relating to, or caused by antibodies or T cells that attack molecules, cells, or tissues of the organism producing them <autoimmune diseases> ANEMIA, BLD LOSS ANEMIA, HEMOLYTIC - hemolytic anemia resulting from immunohemolysis ANOREXIA - loss of appetite especially when prolonged
ANURIA - absence of or defective urine excretion; Acute renal failure occurs when a major insult to the kidneys results in inability to regulate water and solute balance; this may occur when urine flow is reduced. APLASIA, BONE MARROW - aplasia: incomplete or faulty development of an organ or part; BONE MARROW: a soft highly vascular modified connective tissue that occupies the cavities and cancellous part of most bones and occurs in two forms: a : a whitish or yellowish bone marrow consisting chiefly of fat cells and predominating in the cavities of the long bones -- called also yellow marrow b : a reddish bone marrow containing little fat, being the chief seat of red blood cell and blood granulocyte formation, and occurring in the normal adult only in cancellous tissue especially in certain flat bones -- called also red marrow APNEA - transient cessation of respiration whether normal (as in hibernating animals) or abnormal (as that caused by certain drugs) APPREHENSION ARTHRITIS ASCITES - accumulation of serous fluid in the spaces between tissues and organs in the cavity of the abdomen -- called also hydroperitoneum ATAXIA - an inability to coordinate voluntary muscular movements that is symptomatic of some nervous disorders AZOTEMIA - an excess of nitrogenous bodies in the blood as a result of kidney insufficiency BEHAVIOR DISORDER (not specified) BITING/CHEWING BLEEDING:
BLD (bleeding, no location given) BLD, ABDOMEN BLD, ANUS BLD(ECCHYMOSES) - the escape of blood into the tissues from ruptured blood vessels marked by a livid black-and-blue or purple spot or area BLD, GI BLD, INCISION SITE BLD, LUNG(S)/TRACHEA BLD, MOUTH/LIP(S) BLD, PASSING BLD, SCLERA - sclera: from MedLine: sclera: the dense fibrous opaque white outer coat enclosing the eyeball except the part covered by the cornea -- called also sclerotic,sclerotic coat BLD, SKIN BLD, VAGINA BLOAT - from Merck Veterinary Manual: Bloat is an over distention of the rumenoreticulum with the gases of fermentation, either in the form of a persistent foam mixed with the ruminal contents—called primary or frothy bloat, or in the form of free-gas separated from the ingesta—called secondary or free-gas bloat. BORBORYGMI - from MedLine: a rumbling sound made by the movement of gas in the intestine BREATHING ABN CIRCLING CNS/CENTRAL NERVOUS SYSTEM:
CNS INFARCT - from MedLine: CNS:abbreviation central nervous system; Infarct: an area of necrosis in a tissue or organ resulting from obstruction of the local circulation by a thrombus or embolus NEUROLOGICAL DISORDER COLITIS COLLAPSE CONFUSION CONSTIPATION CONVULSION(S)
COUGHING CYANOSIS, MUCOUS MEMBR DEAFNESS DEAFNESS, PARTIAL DEFECATION DEFECATION ABN DEHYDRATION DEMENTIA - from MedLine: a condition of deteriorated mentality that is characterized by marked decline from the individual's former intellectual level and often by emotional apathy DEPRESSION/LETHARGY DESTRUCTIVENESS DIABETES MELLITUS - from MedLine: any of various abnormal conditions characterized by the secretion and excretion of excessive amounts of urine DIABETES M, POOR REGUL DIARRHEA
DIARRHEA, BLOODY
DIARRHEA, MILD DIARRHEA, MUCOID DIARRHEA, SEVERE DIARRHEA, WATERY DIC - per the Merck Veterinary Manual online at: http://www.merckvetmanual.com, I was not able to find "DIC", but the search engine provided 14 "articles" for that search, the first of which is: "Acquired Coagulation Protein Disorders" and states: "Most coagulation proteins are produced primarily in the liver. Therefore, liver disease characterized by necrosis, inflammation, neoplasia, or cirrhosis often is associated with decreased production of coagulation proteins, particularly Factors VII, IX, X, and XI." and refers on to: "(see rodenticide poisoning)". A search of : http://www.medterms.com using "DIC" provided:"3 articles" for search keyword or phrase "DIC", the titles of which are: "Leukemia in the Family", "Acute promyelocytic leukemia" and "APL" which provides a potential definition of "DIC" as "APL is consistently associated with a disorder that resembles (but is not identical to) disseminated intravascular coagulation (DIC). "There is in APL a pronounced tendency to hemorrhage (bleeding). The bleeding can manifest itself as petechiae (little bleeding spots in the skin or elsewhere), small ecchymosis (bruises), epistaxis (nose bleeds), bleeding in the mouth, hematuria (blood in the urine), bleeding from venipuncture and bone marrow sites. . . " so apparently the "translation" of "DIC" is disseminated intravascular coagulation. DIFFICULTY RISING DILITATION, STOMACH - from MedLine: [no such word]: dilatation: 1 : the condition of being stretched beyond normal dimensions especially as a result of overwork or disease or of abnormal relaxation <dilatation of the heart> <dilatation of the stomach> DISCHARGE, INCISION SITE DISCHARGE, NOSE DISCOMFORT DISSOCIATION -from MedLine: the act or process of dissociating : the state of being dissociated:the separation of whole segments of the personality (as in multiple personality) or of discrete mental processes (as in the schizophrenias) from the mainstream of consciousness or of behavior with loss of integrated awareness and autonomous functioning of the separated segments or parts DISTENTION, ABDOMEN DISTRESS DISTRESS, RESP DYSPHAGIA - from MedLine: loss of or deficiency in the power to use or understand language as a result of injury to or disease of the brain DYSPNEA - Respiratory diseases are common in dogs and cats. Although clinical signs such as coughing and dyspnea are commonly referable to primary problems of the respiratory tract, they may also occur secondary to disorders of other organ systems (eg, congestive heart failure). Fever is usually absent. The degree of dyspnea and coughing is related to the severity of inflammation within the airways and alveoli. DYSURIA - from MedicineNet: Dysuria: Painful or difficult urination. This includes burning on urination. Dysuria is most commonly due to bacterial infection of the urinary tract causing inflammation of the bladder (cystitis) or kidney (pyelonephritis). There are many other causes of dysuria including irritation from chemicals. EAR DISORDER EDEMA (location not specified) - from MedLine: an abnormal excess accumulation of serous fluid in connective tissue or in a serous cavity -- called also dropsy EDEMA, BRISKET/CHEST EDEMA, LIMB(S) EDEMA, VENTRAL EFFUSION (location not specified) - from MedLine: 1 a : the escape of a fluid from anatomical vessels by rupture or exudation b : the flow of a gas through an aperture whose diameter is small as compared with the distance between the molecules of the gas 2 : the fluid that escapes by extravasation EFFUSION, PERICARDIAL EFFUSION, PERITONEAL EFFUSION, PLEURAL ENLARGEMENT(S), HEAD/F ENLARGEMENT, LYMPH NOD ENLARGEMENT(S), SKIN EPISTAXIS - from MedLine: epistaxis, melena, gingival bleeding, retinal hemorrhage, hematoma formation, and prolonged bleeding after venipuncture or surgery. Immunologic and inflammatory mechanisms cause increased platelet consumption and decreased platelet survival. EYES:
BLINDNESS CATARACT(S) CONGESTION, EYE(S)/LID EPIPHORA - from MedLine: a watering of the eyes due to excessive secretion of tears or to obstruction of the lacrimal passages EYE DISORDER HORNER'S SYNDROME - from MedLine: a syndrome marked by sinking in of the eyeball, contraction of the pupil, drooping of the upper eyelid, and vasodilation and anhidrosis of the face, and caused by injury to the cervical sympathetic nerve fibers on the affected side MYDRIASIS - from MedLine: excessive or prolonged dilation of the pupil of the eye NYSTAGMUS - from MedLine: a rapid involuntary oscillation of the eyeballs occurring normally with dizziness during and after bodily rotation or abnormally after injuries (as to the cerebellum or the vestibule of the ear)
NYSTAGMUS, HORIZONTAL - back and forth/horitontal SQUINTING FEVER, BODY
FEVER, JOINT(S) FROTH, MOUTH/LIP(S) GAGGING GASTRITIS GLOSSITIS - from MedLine: inflammation of the tongue HAIR, ABN HAIR, SHEDDING HEAD TILT HEART:
CARDIOMEGALY - from MedLine: enlargement of the heart PRESSURE HI, BLD TACHYCARDIA - From MedLine: Rapid heart beat
THROMBUS HEMATOCHEZIA - from MedLine: Decreased red blood cell production HEPATITIS - from MedLine: 1: inflammation of the liver 2 : a disease or condition (as hepatitis A or hepatitis B) marked by inflammation of the liver HEPATOMEGALY - from MedLine: Liver enlargement HYPERACTIVITY HYPERPNEA - Differentiation from other causes of a chronic cough or nasal discharge (eg, parasitic bronchiolitis) is based on the history and other diagnostic procedures such as endoscopy, evaluation of a tracheobronchial exudate, and chest radiography. In its most subtle form, the only clinical sign may be hyperpnea at rest. Cytologic examination of fluid obtained from a tracheal wash or bronchoalveolar lavage usually shows a preponderance of neutrophils with generally normal morphology. HYPERSALIVATION - Slobbering, excessive drooling HYPERSENSITIVE, SOUND HYPOTHERMIA, BODY - From MedLine: Hypothermia is dangerously low body temperature [most suseptible are: Very old or very young, chronically ill, especially with heart or circulation problems, malnourished, overly tired, under the influence of alcohol or drugs ICTERUS, BODY - from MedLine: Icterus: Jaundice. At least one medical dictionary defines icterus as the presence of jaundice seen in the sclera of the eye. This is incorrect. Icterus is synonymous with jaundice. They are one and the same thing. IMMUNE DISORDER - from MedLine: not susceptible or responsive ; especially : not having a high degree of resistance to a disease; not protected by either specific or non-specificmechanisms against infectiousdisease. INCISION SITE ABN INCISION SITE, ECCHYMOSIS INCONTINENCE, FECAL INCONTINENCE, URINARY INEFFECT, ANALGESIA INEFFECT, LOSS OF EFFE INFECTION, URINARY TRA INFLAM (location not specified) INSOMNIA INTERACTION, DRUG(S) IRRITATION, MOUTH/LIP( IRRITATION, PHARYNX/TH KIDNEY DISORDER KIDNEY FAILURE
LAB TESTS/BLOOD:
ALBUMIN LO, BLD ALK PHOS HI, BLD AMYLASE HI, BLD BANDS HI, BLD BILIRUBIN(TOT) HI, BLD BUN HI, BLD BUN LO, BLD CA HI, BLD CA LO, BLD CHEMISTRY ABN CHOLESTEROL HI, BLD CHLORIDE LO, BLD COAGULATION DISORDER CPK HI, BLD CREATININE HI, BLD
URINE ABN WBC, URINE LAMENESS LESION(S), MOUTH/LIP(S LESION(S), SKIN LICKING LICKING, FEET/DIGIT(S) LIVER DISORDER LIVER DISORDER, OBSTRU LIVER FAILURE LOCOMOTION DISORDER MASS (location not specified) MELENA - the passage of dark tarry stools containing decomposing blood that is usually an indication of bleeding in the upper part of the alimentary canal and especially the esophagus, stomach, and duodenum -- compareHEMATOCHEZIA
NAIL DISORDER NAUSEA NEOPLASM (location not specified) - from MedicineNet: Neoplasm: A tumor. An abnormal growth of tissue. The word neoplasm is not synonymous with cancer. A neoplasm may be benign or malignant. NEOPLASM, LIVER NEPHRITIS - from MedLine: acute or chronic inflammation of the kidney affecting the structure (as of the glomerulus or parenchyma) and caused by infection, a degenerative process, or vascular disease NERVOUSNESS NOCTURIA - from MedLine: urination at night especially when excessive -- called also nycturia NOSE ABN OBSTRUCTION, INTESTINE OLIGURIA - from MedLine: reduced excretion of urine PACING PAIN (not specified) PAIN, ABDOMEN PAIN, JOINT(S) PAIN, LIMB(S) PALLOR, MUCOUS MEMBRAN PANCREATITIS PARALYSIS, FACIAL NERV PARALYSIS, HIND LIMB(S PARESIS (location not specified) - from MedLine: Paresis: slight or partial paralysis PARESIS, FORELIMB(S) PARESIS, HIND LIMB(S) PERFORATION, GI PERFORATION, STOMACH PERITONITIS PICA - from MedLine: Pica: A craving for something not normally regarded as nutritive. For example, dirt. PNEUMONIA POLLAKIURIA - from MedLine: abnormally frequent urination POLYCYTHEMIA - from MedLine: a condition marked by an abnormal increase in the number of circulating red blood cells POLYDIPSIA - excessive or abnormal thirst
POLYPNEA - rapid or panting respiration
POLYURIA - excessive secretion of urine POSTURE ABN PR-ADRENAL(S), LESION(S) PR-CEREBELLUM, LESION(S) PR-COLON, LESION(S) PR-HEART, LESION(S) PR-INTEST, LESION(S) PR-KIDNEY(S), LESION(S PR-LIVER, LESION(S) PR-MESENTERY, LESION(S) PR-PERITONEUM, LESION( PR-PLEURAL EFFUSION PR-SM INTEST, LESION(S) PR-SPLEEN, LESION(S) PR-STOMACH, LESION(S) PR-TONGUE, LESION(S) PR-SM INTEST, LESION(S PROPRIOCEPTIVE DISORDE PRURITIS (location not specified) - from MedLine: Pruritus see Itching : Itching is a peculiar tingling or uneasy irritation of the skin that causes a desire to scratch the affected area. Itching may be over the whole body (generalized), or only in a particular location (localized).
PRURITIS, EAR(S) PRURITIS, FEET/DIGIT(S PUSTULE(S) (location not specified) RADIOGRAPH(S) ABN RECUMBENCY - [downer cow] Lifting usually reveals that the hindlimbs are unable to support weight REFLEX(ES) ABN REGURGITATION RELUCTANT TO MOVE SEDATION - 1:the inducing of a relaxed easy state especially by the use of sedatives 2 : a state resulting from sedation SHAKING SHAKING, HEAD/FACE SHOCK - From MedLine: Cardiac function; intravascular volume; and vascular tone, integrity, and patency are each critical to normal circulation. An abnormality in one or more of these components of circulation leads to compensatory changes in the others in an effort to maintain perfusion. The hemodynamic and cellular changes that develop as a result of these abnormalities are called shock. As shock progresses, oxygen and substrate delivery to the tissues becomes insufficient to meet energy requirements for cellular maintenance and repair. If shock progresses to the point when cellular energy demands cannot be met, the hemodynamic and cellular responses become similar for all types of shock. Organ failure ensues, and when progressive, the end result is death. Early recognition of the type of shock and an understanding of the pathophysiologic processes initiated allow aggressive treatment and optimal chances for recovery. SLEEP ABN SKIN:
ALOPECIA -Alopecia is the partial or complete lack of hairs in areas where they are normally BLD(PETECHIAE) - a minute reddish or purplish spot containing blood that appears in skin or mucous membrane especially in some infectious diseases (as typhoid fever) -- compare ECCHYMOSIS CONGESTION, SKIN DERMATITIS, MOIST ERUPTION(S) HYPERPIGMENTATION, SKI INFECTION, SKIN INFLAM, SKIN
LESION(S), SKIN PAPULE(S) - from MedLine: a small solid usually conical elevation of the skin caused by inflammation, accumulated secretion, or hypertrophy of tissue elements RASH SEBORRHEA - abnormally increased secretion and discharge of sebum producing an oily appearance of the skin and the formation of greasy scales SKIN, CRUST(S) SKIN, DRY SKIN, NECROSIS - death of living tissue ; specifically : death of a portion of tissue differentially affected by local injury (as loss of blood supply, corrosion, burning, or the local lesion of a disease) SKIN, SCAB(S)
SLOUGH, SKIN - dead tissue separating from living tissue ; especially : a mass of dead tissue separating from an ulcer URTICARIA - (Hives, Nettle rash) Urticaria is characterized by multiple plaque-like eruptions that are formed by localized edema in the dermis and that often develop and disappear suddenly. VESICLE(S)/BULLAE, SKI - from MedLine: Vesicle(s) 1 a : a membranous and usually fluid-filled pouch (as a cyst, vacuole, or cell) in a plant or animal b : SYNAPTIC VESICLE 2 : a small abnormal elevation of the outer layer of skin enclosing a watery liquid : BLISTER 3 : a pocket of embryonic tissue that is the beginning of an organ -- see BRAIN VESICLE,OPTIC VESICLE - Bullae: 1 : a hollow thin-walled rounded bony prominence 2 : a large vesicle or blister SOMNOLENCE - from MedLine: the quality or state of being drowsy; sleepiness SORE(S)(location not specified) SOUND ABN, RESPIRATORY SOUND ABN, VOICE SPASM STAGGERING STARING STOMATITIS STOOL ABN STRANGURIA - from MedLine: [no such word] One entry found for strangury Main Entry: stran·gu·ry: Inflected Form(s): plural -ries : a slow and painful discharge of urine drop by drop produced by spasmodic muscular contraction of the urethra and bladder STUMBLING STUPOR - From MedLine: Stuporous see Consciousness - decreased: Decreased consciousness refers to diminished alertness or awareness. Decrease in consciousness, unconsciousness, and coma almost always require medical evaluation (with the possible exception of alcohol intoxication, simple fainting, or a previously recognized seizure disorder). SWELLING (location not specified) SWELLING, EAR(S) SWELLING, HEAD/FACE SWELLING, JOINT(S) SWELLING, LIMB(S) SYNCOPE - loss of consciousness resulting from insufficient blood flow to the brain : FAINT SYNOVIAL FLUID ABN - a transparent viscid lubricating fluid secreted by a membrane of an articulation, bursa, or tendon sheath -- called also joint fluid,synovia TENESMUS, RECTAL - from MedLine: a distressing but ineffectual urge to evacuate the rectum or urinary bladder TENESMUS, URINARY (see above) TREMBLING TWITCH ULCER(S), FEET/DIGIT(S ULCER(S), GI ULCER(S), MOUTH/LIP(S) ULCER(S), PYLORUS ULCER(S), SKIN ULCER(S), STOMACH ULCER(S), TONGUE UNCONSCIOUS UNPALATABLE, WON'T EAT URINATION URINATION ABN US ABN US-LIVER ABN VESTIBULAR DISORDER - from MedLine: of or relating to the vestibule of the inner ear, the vestibular apparatus, the vestibular nerve, or the labyrinthine sense (see dizziness, balance disorder) VOCALIZATION VOICE DISORDER VOLVULUS - from MedLine: a twisting of the intestine upon itself that causes obstruction VOLVULUS, STOMACH VOMITING VOMITING, BLOODY VOMITING, SEVERE WEAKNESS WEIGHT LOSS
WHEEZING
SYMPTOMS/CONDITIONS LISTING for other FDA/CVM "approved" NSAIDS for veterinarians:
This information is being provided as a free public service to pet owners so that you can become aware of the known risks/dangers and symptoms/conditions caused by and associated with these NSAIDs [non steroid anti inflammatory drugs] per the FDA/CVM, because chances are that your "trusted" veterinarian will NOT be providing ANY of this information to you.
May my beloved partner ROMI rest in peace - no matter wherever her bits and pieces/frozen carcass may be held hostage.
bravenet.com
site address (4/22/05):