You are at the
page, which is devoted to providing information on the known/reported symptoms/conditions caused by and or associated with the administration of PROHEART 6. All of the information was copied directly from the FDA/CVM ADE [adverse drug event] reports and the only things that have been changed are the alphabetizing of the listed symptoms/conditions (in some cases a "grouping" was done for body systems, which is underlined and highlighted) and medical terminology is provided from: MedLinePlus at: http://www.nlm.nih.gov/medlineplus/mplusdictionary.html unless otherwise indicated.
The music for this page is "Aquarius".
NOTE: This product was "recalled" by the FDA/CVM but there is apparently a "controversy" as to getting it placed back on the market and the other "forms" of this product are still being used by veterinarians. FDA/CVM and Fort Dodge information is below the symptoms/conditions listings.
Heartworm or Heartbreak?
PROHEART 6 RECALL
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
Fort Dodge ProHeart 6 (moxidectin) Sustained Release Injectable for Dogs, Sterile Vehicle 17 ml. to be used to constitute moxidectin microspheres, 10% w/w moxidectin microspheres, packed in 5-unit packs of 20-ml. moxidectin microsphere and vehicle vials, RX, NADA 141-189, NDC 0856-3670-20. Recall # V-130-4.
Lot 367158214, Exp. April 05, and Lot 367158215, Exp. June 05.
Fort Dodge Laboratories, Inc., Fort Dodge, IA, by letters on April 27, 2004. Firm initiated recall is ongoing.
Failing dissolution results for the moxidectin microspheres at the 6-month stability time point.
VOLUME OF PRODUCT IN COMMERCE
FDA/CVM reports - NOTE: site address (4/22/05):
PROHEART 6 (moxidectin)
PARENTERAL, DOG (injection)
FDA/CVM REPORT DATED: April 1, 2005
Reviews: 5269 [11.368% reviews/mortality]
Treated: 6042 [90.58% treated/reacted]
Reacted: 5473 [10.94% reacted/mortality]
ABORTION - the termination of a pregnancy after, accompanied by, resulting in, or closely followed by the death of the embryo or fetus
an abnormal condition of reduced alkalinity of the blood and tissues that is marked by sickly sweet breath, headache, nausea and vomiting, and visual disturbances and is usually a result of excessive acid production -- compare ALKALOSIS
, KETOSIS ADIPSIA - loss of thirst ; also : abnormal and especially prolonged abstinence from the intake of fluids
AGGRESSIONANAPHYLAXIS/TOID - 1 :
hypersensitivity (as to foreign proteins or drugs) resulting from sensitization following prior contact with the causative agent2 : 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.
a condition in which the blood is deficient in red blood cells, in hemoglobin, or in total volume -- see APLASTIC ANEMIA
, HYPERCHROMIC ANEMIA
, HYPOCHROMIC ANEMIA
, MEGALOBLASTIC ANEMIA
, MICROCYTIC ANEMIA
, PERNICIOUS ANEMIA
, SICKLE-CELL ANEMIA
; compare OLIGOCYTHEMIAANEMIA, APLASTIC: anemia that is characterized by defective function of the blood-forming organs (as the bone marrow) and is caused by toxic agents (as chemicals or X rays) or is idiopathic in origin -- called also hypoplastic anemia
ANEMIA, AUTOIMMUNE HEM: AUTOIMMUNE: 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 -
anemia caused by excessive destruction (as in chemical poisoning, infection, or sickle-cell anemia) of red blood cells. ANEMIA, REGEN
ANESTH RECOV PROLONGED
ANOREXIA - loss of appetite especially when prolonged
ANURIA - absence of or defective urine excretion
APLASIA, BONE MARROW - No entries found that match 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)
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
ATROPHY, MUSCLE(S) - ATROPHY: decrease in size or wasting away of a body part or tissue ; also : arrested development or loss of a part or organ incidental to the normal development or life of an animal or plant
AZOTEMIA - an excess of nitrogenous bodies in the blood as a result of kidney insufficiency -- compare UREMIA
BEHAVIOR DISORDER (unspecified)
BLD(ECCHYMOSES) - ECCHYMOSES:
the escape of blood into the tissues from ruptured blood vessels marked by a livid black-and-blue or purple spot or area ; also :
the discoloration so caused -- compare PETECHIA BLD, EAR(S)
BLD(HEMATOMA) - HEMATOMA: a mass of usually clotted blood that forms in a tissue, organ, or body space as a result of a broken blood vessel
BLD, INCISION SITE
BLD, LUNG(S)/TRACHEA BLD, MOUTH/LIP(S)
BLD, MULT SITES
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
BLD(PURPURA) - PURPURA: any of several hemorrhagic states characterized by patches of purplish discoloration resulting from extravasation of blood into the skin and mucous membranes. BLD, RECTUM
BLOAT - to make turgid: a : to produce edema in b : to cause or result in accumulation of gas in the digestive tract of <cucumbers sometimes bloat me>
BORBORYGMI - a rumbling sound made by the movement of gas in the intestine
BRAIN, NEOPLASM - NEOPLASM: a new growth of tissue serving no physiological function : TUMOR -- compare CANCER BREATHING ABN
acute or chronic inflammation of the bronchial tubes ; also :
a disease marked by this CACHEXIA - general physical wasting and malnutrition usually associated with chronic disease
CAT SCAN ABN
CHOLECYSTITIS - inflammation of the gallbladder
CNS DISORDER - CNS: abbreviation central nervous system CNS INFARCT - INFARCT: an area of necrosis in a tissue or organ resulting from obstruction of the local circulation by a thrombus or embolus
COLITIS - inflammation of the colon -- see ULCERATIVE COLITIS: a nonspecific inflammatory disease of the colon that is of unknown cause and is characterized by diarrhea with discharge of mucus and blood, cramping abdominal pain, and inflammation and edema of the mucous membrane with patches of ulceration
CONGESTION - an excessive accumulation especially of blood in the blood vessels of an organ or part whether natural or artificially induced (as for therapeutic purpose)
CONGESTION, MUCOUS MEM
CONVULSION(S) - an abnormal violent and involuntary contraction or series of contractions of the muscles -- often used in plural <a patient suffering from convulsions>
CYANOSIS - a bluish or purplish discoloration (as of skin) due to deficient oxygenation of the blood
CYANOSIS, MUCOUS MEMBR - MUCOUS MEMBRANE: a membrane rich in mucous glands ; specifically : one that lines body passages and cavities which communicate directly or indirectly with the exterior (as the alimentary, respiratory, and genitourinary tracts), that functions in protection, support, nutrient absorption, and secretion of mucus, enzymes, and salts, and that consists of a deep vascular connective-tissue stroma which in many parts of the alimentary canal contains a thin but definite layer of nonstriated muscle and a superficial epithelium which has an underlying basement membrane and varies in kind and thickness but is always soft and smooth and kept lubricated by the secretions of the cells and numerous glands embedded in the membrane -- called also mucosa -- compare SEROUS MEMBRANE
DEHYDRATION - the process of dehydrating ; especially : an abnormal depletion of body fluids
DEMENTIA - a condition of deteriorated mentality that is characterized by marked decline from the individual's former intellectual level and often by emotional apathy.
DIABETES - any of various abnormal conditions characterized by the secretion and excretion of excessive amounts of urine ; especially : DIABETES MELLITUS
DIABETES MELLITUS - a variable disorder of carbohydrate metabolism caused by a combination of hereditary and environmental factors and usually characterized by inadequate secretion or utilization of insulin, by excessive urine production, by excessive amounts of sugar in the blood and urine, and by thirst, hunger, and loss of weight -- see INSULIN-DEPENDENT DIABETES MELLITUS, NON-INSULIN-DEPENDENT DIABETES MELLITUS
DIABETES M, POOR REGUL
DIARRHEA, MUCOIDDILITATION, ESOPHAGUS - No entries found that match DILITATION; 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>
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.
2 : DILATION 1 : the state of being dilated : DILATATION 2 : the action of stretching or enlarging an organ or part of the body <dilation of the cervix> <dilation of the pupil with atropine>
DISCOMFORT, MOUTH/LIP(S)DISTENTION, ABDOMEN
DYSPHAGIA - difficulty in swallowing DYSPNEA - difficult or labored respiration
DYSMETRIA - impaired ability to estimate distance in muscular action
DYSURIA - difficult or painful discharge of urine
EAR DISORDER (unspecified)
ECCHYMOSIS, INCISION SITE - ECCHYMOSIS: the escape of blood into the tissues from ruptured blood vessels marked by a livid black-and-blue or purple spot or area ; also : the discoloration so caused -- compare PETECHIA
EDEMA - an abnormal excess accumulation of serous fluid in connective tissue or in a serous cavity -- called also dropsy
EDEMA, MULTIPLE SITES
EFFUSION - 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 -- see PLEURAL EFFUSION
EMBOLUS - an abnormal particle (as an air bubble) circulating in the blood
EMPHYSEMA - a condition characterized by air-filled expansions like blisters in interstitial or subcutaneous tissues ; specifically : a local or generalized condition of the lung marked by distension, progressive loss of elasticity, and eventual rupture of the alveoli and accompanied by labored breathing, a husky cough, and frequently by impairment of heart action
ENCEPHALOPATHY - a disease of the brain ; especially : one involving alterations of brain structure
ENLARGEMENT, LYMPH NOD
ENTERITIS - 1 : inflammation of the intestines and especially of the human ileum 2 : a disease of domestic animals (as panleukopenia of cats) marked by enteritis and diarrhea
EPISTAXIS - NOSEBLEED: an attack of bleeding from the nose -- called also epistaxis
ERG ABN - abbreviation: electroretinogram EYES:
ERYTHEMA, SCROTUM - abnormal redness of the skin due to capillary congestion (as in inflammation)
ESTRUS CYCLE ABNORMAL
ANISOCORIA - inequality in the size of the pupils of the eyes
BLEPHAROSPASM - spasmodic winking from involuntary contraction of the orbicularis oculi muscle of the eyelids
CATARACT(S) - a clouding of the lens of the eye or its surrounding transparent membrane that obstructs the passage of light
CONJUNCTIVITIS - inflammation of the conjunctiva
EPIPHORA - a watering of the eyes due to excessive secretion of tears or to obstruction of the lacrimal passages
EYE DISORDER (unspecified)
GLAUCOMA - a disease of the eye marked by increased pressure within the eyeball that can result in damage to the optic disk and gradual loss of vision
HORNER'S SYNDROME - 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
HYPHEMA -a hemorrhage in the anterior chamber of the eye
HYPOESTHESIA, EYE(S)/L - HYPOESTHESIA: impaired or decreased tactile sensibility
KERATOCONJUNCTIVITIS S - combined inflammation of the cornea and conjunctiva;; especially : EPIDEMIC KERATOCONJUNCTIVITIS -- compare KERATITIS , DRY EYE: a condition associated with inadequate tear production and marked by redness of the conjunctiva, by itching and burning of the eye, and usually by filaments of desquamated epithelial cells adhering to the cornea -- called also keratoconjunctivitis sicca
MIOSIS - excessive smallness or contraction of the pupil of the eye
MYDRIASIS - excessive or prolonged dilation of the pupil of the eye
NEURITIS, OPTIC - inflammation of the optic nerve NYSTAGMUS - 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, ROTARY OPACITY, CORNEA(S)
PARAESTHESIA, EYE(S)/L - a sensation of pricking, tingling, or creeping on the skin having no objective cause and usually associated with injury or irritation of a sensory nerve or nerve root
PROLAPSE, THIRD EYELID
PRURITIS, EYE(S) - No entries found that match PRURITIS; PRURITUS: localized or generalized itching due to irritation of sensory nerve endings from organic or psychogenic causes : ITCH
PUPIL(S), AREFLEXIA - AREFLEXIA: absence of reflexes
STRABISMUS - inability of one eye to attain binocular vision with the other because of imbalance of the muscles of the eyeball -- called also heterotropia, squint
UVEITIS - inflammation of the uvea; UVEA: the middle layer of the eye consisting of the iris and ciliary body together with the choroid coat -- called also vascular tunic
VISION DISORDER (unspecified)
FLY BITING - from Merck Veterinary Manual online: A specific type of seizure known as temporal lobe epilepsy appears to be familial in Cavalier King Charles Spaniels and is characterized by behavioral manifestations such as fly biting
GALL BLADDER, ABN
GASTRITIS - inflammation especially of the mucous membrane of the stomach
GASTROENTERITIS - inflammation of the lining membrane of the stomach and the intestines
GINGIVA, ABN - GUM
GINGIVITIS - inflammation of the gums
GRANULOMA (unspecified location) - a mass or nodule of chronically inflamed tissue with granulations that is usually associated with an infective process
ARREST, HEART - to bring to a standstill or state of inactivity <arrested tuberculosis> <arrested labor> intransitive verb : to undergo cardiac arrest <the ... patient has arrested while being transported to surgery -- CARDIAC ARREST: temporary or permanent cessation of the heartbeat
ARRHYTHMIA - an alteration in rhythm of the heartbeat either in time or force
BRADYCARDIA - relatively slow heart action whether physiological or pathological -- compare TACHYCARDIA
enlargement of the heart
ECG ABN - abbreviation: electrocardiogram
EFFUSION, PERICARDIAL - 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 -- see PLEURAL EFFUSION
: 1 :
an exudation of fluid from the blood or lymph into a pleural cavity 2 :
an exudate in a pleural cavity FIBRILLATION, ATRIAL - very rapid uncoordinated contractions of the atria of the heart resulting in a lack of synchronism between heartbeat and pulse beat -- called also auricular fibrillation
HEART DISORDER (unspecified)
MURMUR, HEART - an atypical sound of the heart indicating a functional or structural abnormality -- called also heart murmur
NEOPLASM, HEART - a new growth of tissue serving no physiological function : TUMOR -- compare CANCER
PRESSURE HI, BLD
PRESSURE LO, BLD
PULSE THREADY TACHYCARDIA - relatively rapid heart action whether physiological (as after exercise) or pathological -- see JUNCTIONAL TACHYCARDIA, PAROXYSMAL TACHYCARDIA, SINUS TACHYCARDIA, VENTRICULAR TACHYCARDIA
; compare BRADYCARDIA
HEMATOCHEZIA -the passage of blood in the feces -- compare MELENA
HEPATITIS - 1 : inflammation of the liver 2 : a disease or condition (as hepatitis A or hepatitis B) marked by inflammation of the liver
HYPERESTHESIA (location unspecified) - unusual or pathological sensitivity of the skin or of a particular sense to stimulation <tactile hyperesthesia of the leg>
HYPERPNEA - abnormally rapid or deep breathing
HYPERSALIVATION - excessive salivation (drooling, slobbering)
HYPERTONIA - One entry found for hypertonia: HYPERTONICITY the quality or state of being hypertonic HYPERTONIC: 1 : exhibiting excessive tone or tension <a hypertonic baby> <a hypertonic bladder> 2 : having a higher osmotic pressure than a surrounding medium or a fluid under comparison <animals that produce urine which is hypertonic to their blood>
HYPOADRENOCORTICISM - abnormally decreased activity of the adrenal cortex (as in Addison's disease)
HYPOMOTILITY - abnormal deficiency of movement ; specifically : decreased motility of all or part of the gastrointestinal tract <esophageal hypomotility>
HYPOPNEA - abnormally slow or especially shallow respiration
HYPOTHERMIA - subnormal temperature of the body <hypothermia, defined as temperature under 36.6°C -- Emergency Medicine>
ICTERUS - JAUNDICE 1 : a yellowish pigmentation of the skin, tissues, and certain body fluids caused by the deposition of bile pigments that follows interference with normal production and discharge of bile (as in certain liver diseases) or excessive breakdown of red blood cells (as after internal hemorrhage or in various hemolytic states) -- called also icterus 2 : any disease or abnormal condition (as hepatitis A or leptospirosis) that is characterized by jaundice -- called also icterus
INCISION SITE ABN
INCISION SITE, ECCHYMOSIS - ECCHYMOSIS: the escape of blood into the tissues from ruptured blood vessels marked by a livid black-and-blue or purple spot or area ; also : the discoloration so caused -- compare PETECHIA
INCONTINENCE - inability of the body to control the evacuative functions
INFARCT - an area of necrosis in a tissue or organ resulting from obstruction of the local circulation by a thrombus or embolus
INEFFECT, HOOKS PREVEN
INEFFECT, HW ADULTS
INEFFECT, HW ANTIGEN
INEFFECT, HW LARVAE
INFLAM - (unspecified)
INJ SITE ABN
INJ SITE ABSCESS
INJ SITE ALOPECIA - ALOPECIA:
loss of hair, wool, or feathers : BALDNESS INJ SITE BLD
INJ SITE EDEMA - EDEMA: an abnormal excess accumulation of serous fluid in connective tissue or in a serous cavity -- called also dropsy
INJ SITE EFFUSION - EFFUSION: 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 -- see PLEURAL EFFUSION
INJ SITE FIBROSIS - a condition marked by increase of interstitial fibrous tissue : fibrous degeneration
INJ SITE HAIR, ABN
INJ SITE INDURATION - 1 : an increase in the fibrous elements in tissue commonly associated with inflammation and marked by loss of elasticity and pliability : SCLEROSIS 2 : a hardened mass or formation
INJ SITE INFECTINJ SITE INFLAM
INJ SITE MASS
INJ SITE NECROSIS - 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)
INJ SITE NEOPLASM - NEOPLASM: a new growth of tissue serving no physiological function : TUMOR
-- compare CANCER INJ SITE PAIN
INJ SITE PRURITIS - PRURITIS: No entries found that match PRURITIS; PRURITUS: localized or generalized itching due to irritation of sensory nerve endings from organic or psychogenic causes : ITCH
INJ SITE SEPSIS - a toxic condition resulting from the spread of bacteria or their products from a focus of infection ; especially : SEPTICEMIA
INJ SITE SEROMA - No entries found that match SEROMA; SARCOMA: a malignant neoplasm arising in tissue of mesodermal origin (as connective tissue, bone, cartilage, or striated muscle) that spreads by extension into neighboring tissue or by way of the bloodstream -- compare CANCER 1, CARCINOMA; TUMOR
INJ SITE STERILE ABSCEINJ SITE STIFFNESS
INJ SITE SLOUGH - SLOUGH: dead tissue separating from living tissue ; especially : a mass of dead tissue separating from an ulcer
INJ SITE SWELLING
INJ SITE ULCER(S)INJURY
INTUSSUSCEPTION - INTUSSUSCEPTION: 1 : INVAGINATION ; especially : the slipping of a length of intestine into an adjacent portion usually producing obstruction 2 : the deposition of new particles of formative material among those already embodied in a tissue or structure (as in the growth of living organisms)
KETOSIS - 1 : an abnormal increase of ketone bodies in the body in conditions of reduced or disturbed carbohydrate metabolism (as in uncontrolled diabetes mellitu
A/G RATIO HI, BLD
ALBUMIN HI, BLD
ALBUMIN LO, BLD
ALK PHOS HI, BLD
AMYLASE HI, BLD
BANDS HI, BLD
BASOS HI, BLD
BILE ACIDS HI, BLD
BILIRUBIN(DIR) HI, BLD
BILIRUBIN(IND) HI, BLD
BILIRUBIN(TOT) HI, BLD
BUN HI, BLD
BUN LO, BLD
CA HI, BLD
CA LO, BLD
CAPILLARY REFILL PROLO
CHOLESTEROL HI, BLD
CHOLESTEROL LO, BLD
CHLORIDE HI, BLD
CHLORIDE LO, BLD
CPK HI, BLD
CO2 HI, BLD
COOMBS TEST POS
CREATININE HI, BLD
CREATININE LO, BLD
CSF ABN: abbreviation: COLONY-STIMULATING FACTOR : any of several glycoproteins that promote the differentiation of stem cells especially into blood granulocytes and macrophages and that stimulate their proliferation into colonies in culture -- see GRANULOCYTE COLONY-STIMULATING FACTOR: granulocyte colony-stimulating factor: a colony-stimulating factor produced by macrophages, endothelial cells, and fibroblasts that acts to promote the maturation of precursor cells into granulocytes (as neutrophils) -- abbreviation G-CSF, GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR: a colony-stimulating factor produced by T cells, macrophages, endothelial cells, and fibroblasts that promotes the differentiation of bone marrow stem cells, stimulates the maturation of precursor cells into granulocytes and macrophages, and activates mature macrophages -- abbreviation GM-CSF; INTERLEUKIN-3: an interleukin that is a colony-stimulating factor produced especially by T cells stimulated by mitogen or antigen and that promotes the proliferation and differentiation of various stem cells (as hematopoietic stem cells); , MACROPHAGE COLONY-STIMULATING FACTOR a colony-stimulating factor produced by macrophages, endothelial cells, and fibroblasts that stimulates production and maturation of macrophages -- abbreviation M-CSF ;
EOSINOS HI, BLD
EOSINOS LO, BLD
FE HI, BLD
FIBRINOGEN LO, BLD
GGT HI, BLD
GLOBULIN HI, BLD
GLOBULIN LO, BLD
GLUCOSE HI, BLD
GLUCOSE LO, BLD
HCO3 LO, BLD
K HI, BLD
K LO, BLD
KIDNEY VALUES HI, BLD
LDH HI, BLD
LIPASE HI, BLD
LIPIDS HI, BLD
LIVER ENZYMES HI, BLD
LIVER PROFILE HI
LYMPHS HI, BLD
LYMPHS LO, BLD
MG HI, BLD
MG LO, BLD
MONOS HI, BLD
MONOS LO, BLD
NA HI, BLD
NA LO, BLD
P HI, BLD
P LO, BLD
PANCREAS ENZYMES HI, B
PLATELETS HI, BLD
PLATELETS LO, BLD
PROTEIN(TOT) HI, BLD
PROTEIN(TOT) LO, BLD
PT PROLONGED, BLD
PTT PROLONGED, BLD
RETICULOCYTES HI, BLD
SEGS HI, BLD
SEGS LO, BLD
SGOT/AST HI, BLD
SGPT/ALT HI, BLD
THYROID HORMONE(S) LO
TRIGLYCERIDES HI, BLD
WBC HI, BLD
WBC LO, BLD
ABN COLOR, URINE
ALBUMIN HI, URINE
CORT/CREAT HI, URINE
INFECTION, URINARY TRA
K HI, URINE
SPEC GRAVITY HI, URINE
SPEC GRAVITY LO, URINE
LESION(S) (location unspecified)
LIVER DISORDER, OBSTRU
LOSS OF CONDITION
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 -- compare HEMATOCHEZIA
- being in the state of dying : approaching death <in the moribund patient deepening stupor and coma are the usual preludes to deat
h MRI SCAN ABN
MUCOUS MEMBR, ABN COLO
MUCOUS MEMBR, MUDDY
MUCOUS MEMBR, REDMYOSITIS - muscular discomfort or pain from infection or an unknown cause
NEOPLASM (unspecified) NEOPLASM: a new growth of tissue serving no physiological function : TUMOR -- compare CANCER
NEOPLASM, BONENEOPLASM, LIVER
NEOPLASM, LYMPH NODE(S
NEOPLASM, MULT SITES
NEPHRITIS - 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
NERVOUSNESSNEURITIS - an inflammatory or degenerative lesion of a nerve marked especially by pain, sensory disturbances, and impaired or lost reflexes
NEUROPATHY - an abnormal and usually degenerative state of the nervous system or nerves ; also : a systemic condition (as muscular atrophy) that stems from a neuropathy
NOSE ABNOBSTRUCTION, ESOPHAGUS
OLIGURIA - reduced excretion of urine
OPISTHOTONOS - a condition of spasm of the muscles of the back, causing the head and lower limbs to bend backward and the trunk to arch forward
inflammation of the ear
PAIN, HIND LIMB(S)
PALLOR, MUCOUS MEMBRAN
PANCREATITIS - inflammation of the pancreas
PANCYTOPENIA - an abnormal reduction in the number of red blood cells, white blood cells, and blood platelets in the blood ; also : a disorder (as aplastic anemia) characterized by such a reduction
PARALYSIS - complete or partial loss of function especially when involving the power of motion or of sensation in any part of the body -- see HEMIPLEGIA, PARAPLEGIA, PARESIS
PARALYSIS, ALL LIMBS
PARALYSIS, FACIAL NERV
PARALYSIS, HIND LIMB(S
PARESIS - slight or partial paralysis
PARESIS, FORE LIMB(S)
PARESIS, FORELIMB(S) (although this appears to be a duplicate on the FDA/CVM ADE report, it has been left on this list for "accuracy")
PARESIS, HIND LIMB(S)
PARESTHESIA, MOUTH/LIP - PARESTHESIA: a sensation of pricking, tingling, or creeping on the skin having no objective cause and usually associated with injury or irritation of a sensory nerve or nerve root
PERFORATION, GI - the act or process of perforating ; specifically : the penetration of a body part through accident or disease <spontaneous perforation of the sigmoid colon in the presence of diverticulosis
PHARYNGITIS - inflammation of the pharynx
PHOTOPHOBIA - 1 : intolerance to light ; especially : painful sensitiveness to strong light 2 : an abnormal fear of light
PICA - an abnormal craving for and eating of substances (as chalk, ashes, or bones) not normally eaten that occurs in nutritional deficiency states (as aphosphorosis) in humans or animals or in some forms of mental illness
POLYCYTHEMIA - a condition marked by an abnormal increase in the number of circulating red blood cells
POLYDIPSIA - excessive or abnormal thirst
POLYPHAGIA - excessive appetite or eating
POLYPNEA - rapid or panting respiration
POLYURIA - excessive secretion of urine
PROPRIOCEPTIVE DISORDE - PROPRIOCEPTIVE: activated by, relating to, or being stimuli arising within the organism <proprioceptive reflexes> <proprioceptive feedback
PR-BLD VESSEL(S), LESI
PR-BONE MARROW, LESION
PR-GALL BLADDER, LESION(S)
PR-INJ SITE, LESION(S)
PR-LYMPH NODE(S), LESI
PR-MULT SITES, BLD
PR-MULT SITES, CONGEST
PR-MULT SITES, ICTERUS
PR-MULT SITES, LESION(S)
PR-SM INTEST, LESION(S
PR-SPINAL CORD, LESION
PROLAPSE, DISC - PROLAPSE: the falling down or slipping of a body part from its usual position or relations <prolapse of the uterus> <prolapse of an intervertebral disk>
PROSTRATION - complete physical or mental exhaustion
PROSTATOMEGALY - No entries found that match PROSTATOMEGALY
PRURITIS - No entries found that match PRURITIS: PRURITUS: localized or generalized itching due to irritation of sensory nerve endings from organic or psychogenic causes : ITCH
RECUMBENCY - the state of leaning, resting, or reclining ; also : a recumbent position <emphasized that recumbency may ... be harmful to the patient who is acutely ill with cardiac disease --
REGURGITATIONRELUCTANT TO CLIMB
RELUCTANT TO MOVE
SEDATION - 1 : the inducing of a relaxed easy state especially by the use of sedatives 2 : a state resulting from sedation
- a toxic condition resulting from the spread of bacteria or their products from a focus of infection ; especially : SEPTICEMIA SEPTICEMIA - invasion of the bloodstream by virulent microorganisms from a focus of infection that is accompanied by chills, fever, and prostration and often by the formation of secondary abscesses in various organs -- called also blood poisoning
SHAKING, HEAD/FACESHOCK - 1 : a sudden or violent disturbance in the mental or emotional faculties 2 : a state of profound depression of the vital processes of the body that is characterized by pallor, rapid but weak pulse, rapid and shallow respiration, reduced total blood volume, and low blood pressure and that is caused usually by severe especially crushing injuries, hemorrhage, burns, or major surgery <the patient was admitted to the hospital in shock> 3 : sudden stimulation of the nerves or convulsive contraction of the muscles accompanied by a feeling of concussion that is caused by the discharge through the animal body of electricity from a charged source; 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
ALOPECIA - loss of hair, wool, or feathers : BALDNESS
APPLICATION SITE ALOPECIA
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 ; also : the discoloration so caused -- compare PETECHIA
CELLULITIS - diffuse and especially subcutaneous inflammation of connective tissue
DERMATITIS, MOIST - DERMATITIS: inflammation of the skin -- called also dermitis
ERUPTION(S) ERYTHEMA MULTIFORME - a skin disease characterized by papular or vesicular lesions and reddening or discoloration of the skin often in concentric zones about the lesions
EXFOLIATION, SKIN - EXFOLIATION: the action or process of exfoliating: as a : the peeling of the horny layer of the skin (as in some skin diseases) b : the shedding of surface components (as cells from internal body surfaces when diseased) c : the shedding of a superficial layer of bone or of a tooth or part of a tooth
HAIR, ABN COLOR
HYPERKERATOSIS - 1 : hypertrophy of the stratum corneum layer of the skin 2 a : any of various conditions marked by hyperkeratosis b : a disease of cattle that is marked by thickening and wrinkling of the hide, by formation of papillary outgrowths on the buccal mucous membranes, and often by a watery discharge from eyes and nose, diarrhea, loss of weight, and abortion of pregnant animals and that is caused especially by ingestion of the chlorinated naphthalene of various lubricating oils, by arsenic poisoning, or by inherited congenital ichthyosis -- called also X-disease, XX disease
HYPERPIGMENTATION, SKI - HYPERPIGMENTATION: excess pigmentation in a bodily part or tissue (as the skin) <brown hyperpigmentation with accentuation in sun-exposed areas
INJ SITE HAIR, ABN COLOR
INJ SITE, ALOPECIA
LEUKODERMA - a skin abnormality that is characterized by a usually congenital lack of pigment in spots or bands and produces a patchy whiteness
MACULE(S) - a patch of skin that is altered in color but usually not elevated and that is a characteristic feature of various diseases (as smallpox)
NEOPLASM, SKIN - see NEOPLASM
PAPULE(S) - a small solid usually conical elevation of the skin caused by inflammation, accumulated secretion, or hypertrophy of tissue elements
PUSTULE(S) - 1 : a small circumscribed elevation of the skin containing pus and having an inflamed base 2 : a small often distinctively colored elevation or spot resembling a blister or pimple
SEBORRHEA - abnormally increased secretion and discharge of sebum producing an oily appearance of the skin and the formation of greasy scales
SKIN, NECROSIS - 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)
SLOUGH, SKIN - SLOUGH: dead tissue separating from living tissue ; especially : a mass of dead tissue separating from an ulcer
URTICARIA - HIVES
VESICLE(S)/BULLAE, SKI - VESICLE: 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; BULLAE
: 1 :
a hollow thin-walled rounded bony prominence2 :
a large vesicle or blister SLEEP ABN
SLOUGH, FEET/DIGIT(S) - SLOUGH: dead tissue separating from living tissue ; especially : a mass of dead tissue separating from an ulcer
SOMNOLENCE - the quality or state of being drowsy
SORE(S) (unspecified type/location)
SOUND ABN, RESPIRATORY
SOUND ABN, VOICE
SPLENOMEGALY - abnormal enlargement of the spleen
SPINAL CORD, NEOPLASM - NEOPLASM: a new growth of tissue serving no physiological function : TUMOR -- compare CANCER STAGGERING
STIFFNESS, FRONT LIMB(
STIFFNESS, HIND LIMB(S
STRANGURIA - No entries found that match STRANGURIA. strangury: a slow and painful discharge of urine drop by drop produced by spasmodic muscular contraction of the urethra and bladder
SWELLING, MULT SITES
TENESMUS - a distressing but ineffectual urge to evacuate the rectum or urinary bladder
TETANY - a condition of physiological calcium imbalance that is marked by intermittent tonic spasm of the voluntary muscles and is associated with deficiencies of parathyroid secretion or other disturbances (as vitamin D deficiency)
THROMBUS - a clot of blood formed within a blood vessel and remaining attached to its place of origin -- compare EMBOLUS
TORTICOLLIS - a twisting of the neck to one side that results in abnormal carriage of the head and is usually caused by muscle spasms -- called also wryneck TRANSUDATE - a transuded substance ; to pass through a membrane or permeable substance transitive verb : to permit passage of
VASCULITIS - inflammation of a blood or lymph vessel -- called also angiitis
VESTIBULAR DISORDER - 1 : of or relating to the vestibule of the inner ear, the vestibular apparatus, the vestibular nerve, or the labyrinthine sense <vestibular impulses> 2 : lying within or facing the vestibule of the mouth <the vestibular surface of a tooth>
VOLVULUS (site unspecified) - a twisting of the intestine upon itself that causes obstruction
PROHEART 6 (MOXIDECTIN) ORAL/DOG
Report Date: 4/01/05
Reviews: 251 [24.70% Reviews/Mortality]
Treated: 391 [90.28% treated/reacted]
Reacted: 353 [17.56% reacted/mortality]
ANEMIA, AUTOIMMUNE HEM
INEFFECT, HW ADULTS
INEFFECT, HW LARVAE
INJ SITE PAIN
INJ SITE SEROMA
ALK PHOS HI, BLD
BILIRUBIN(TOT) HI, BLD
WBC HI, BLD
MUCOUS MEMBR, MUDDY
MUCOUS MEMBR, RED
PALLOR, MUCOUS MEMBRAN
PARESIS, HIND LIMB(S)
PROHEART 6 (moxidectin) TOPICAL, DOG
FDA/CVM Report Date: 4/01/05
Reviews: 5 [20% Reviews/Mortality]
Treated: 14 [42.85% Treated/Reacted]
Reacted: 6 [16.66% Reacted/Mortality]
APPLICATION SITE PAIN
INJ SITE SWELLING
PALLOR, MUCOUS MEMBRAN
PROHEART 5 (moxidectin) UNKNOWN, DOG
FDA/CVM Report Date: 4/01/05
Reviews: 41 [4.87% Reviews/Mortality]
Treated: 58 [3.44% Treated/Reacted]
Reacted: 55 [3.64% Reacted/Mortality]
CREATININE HI, BLD
INEFFECT, HW LARVAE
INJ SITE ABN
INJ SITE ABSCESS
INJ SITE BLD
INJ SITE EDEMA
INJ SITE MASS
BUN HI, BLD
K HI, BLD
PANCREAS ENZYMES HI, B
PLATELETS LO, BLD
PR-INJ SITE, LESION(S)
RELUCTANT TO MOVE
SWELLING, MULT SITES
Questions and Answers regarding the FDA Recall of ProHeart®6
From a Pet Owners Perspective:
Q: Why did CVM ask Fort Dodge Animal Health to recall ProHeart®6?
A: Since the product was approved in June 2001, we have received reports of nearly 5,500 serious adverse drug reactions attributed to ProHeart® 6. After evaluating these reports, the Center for Veterinary Medicine (CVM) determined that at least 1,900 of those were unrelated to the concurrent administration of other drugs or vaccines. The clinical signs contained in those reports were possibly or probably associated with the ProHeart®6 injection. Many of the adverse events were severe, including more than 600 reports of death.
The actual incidence of adverse events is likely to be even higher than reported, because studies show that only a fraction of actual adverse reactions are reported. Based on its experience with adverse drug reactions attributed to animal drugs over the years, CVM considers the number and severity of those attributed to ProHeart®6 to be unacceptable, even when considering the number of doses of the drug that have been administered.
FDA's concern is based on voluntary self-reporting to FDA by veterinarians and owners whose dogs have suffered adverse drug experiences (ADEs) to ProHeart®6 (which contains the drug moxidectin) as well as the mandatory reporting of adverse events by the product’s sponsor, Fort Dodge Animal Health (FDAH).
CVM has worked with Fort Dodge to investigate numerous adverse event reports to try to determine the cause of the problem. At FDA’s request, the product sponsor has also made three revisions to the label to include post approval safety information including rare reports of death and a caution to practitioners that dogs should have a negative test for heartworm before administration of ProHeart®6. The firm has also added a Client Information Sheet and issued two “Dear Doctor” letters to advise veterinarians and pet owners of the risks associated with use of the product. Despite these label changes and educational efforts, FDA is still receiving an unacceptable number of reports of unexplained and severe adverse events.
Because the cause of the problems associated with ProHeart®6 have not been identified or remedied, and because veterinarians and dog owners have effective alternative heartworm products available to them, CVM believes that removing the product from the market is in the best interest of the dogs and their owners.
As of September 10, 2004, Fort Dodge submitted the more than 5,500 adverse event reports in compliance with federal regulations (21 CFR §514.80) that require sponsors to submit serious and unexpected adverse drug events within 15 working days of first receiving the information.
Q: Had CVM made Fort Dodge aware of the problem before asking for the product recall?
A: CVM has been working with Fort Dodge Animal Health to investigate the numerous adverse event reports to determine the cause of the problem. At FDA’s request, the product sponsor has also made three revisions to the label to include post approval safety information including rare reports of death and a caution to practitioners that dogs should test negative for heartworms before administration of ProHeart®6. The firm has also added a Client Information Sheet, and issued two “Dear Doctor” letters to advise veterinarians and pet owners of the risks associated with use of the product. Discussions with Fort Dodge have been ongoing. CVM has requested that the firm continue to conduct research to determine the cause of related adverse reactions and develop a strategy to help prevent such problems in the future before the product is marketed again.
Q: What are Adverse Drug Experience reports? How does the system work?
A: Adverse Drug Experience (ADE) reports are voluntary descriptions of side effects that appear to be caused by a drug. Approximately 99% of the ADE reports are filed by veterinarians with the remaining 1% or so coming from consumers. Typically, the reports are filed with the drug sponsor, who is required to send them all to CVM for review and analysis.
Q: How are ADE reports analyzed?
A: CVM adverse drug experience reviewers, who are experienced veterinarians, use a standardized method to determine whether the side effects are caused by the drug. The multi-part system used by reviewers evaluates the following criteria: previous experience with the drug (the reviewers determine if the side effects have already been predicted), the timing of the reaction, whether the dog was overdosed, whether other disease factors are present, and what happened if the drug was withdrawn or reintroduced. The reports are given a causality score, and only the reports that show the possibility that side effects are associated with the use of the drug are considered when CVM is determining the safety of a product. Those reports that indicate only a remote likelihood that the drug caused the reaction are not considered when determining whether a drug is safe.
Q: Do you get ADE reports on other animal drugs?
A: Yes, in fact we typically receive many ADE reports following a drug’s approval, and the Center’s experts are constantly reviewing them to identify specific problems and determine the severity or frequency of problems. When problems are detected through this analysis, CVM begins working with the company to determine the cause and potential remedies. The remedies can include label or even dosage changes. In the case of ProHeart®6, the root cause of the severe side effects has not been found, and none of the steps the company has taken, including label changes, has reduced the problem. Therefore, CVM requested that Fort Dodge Animal Health remove the product from the market to protect the health of the dogs.
Q: When will the product be allowed back on the market?
A: There is no way to predict that. FDA is requesting that the firm continue to conduct research to determine the cause of related adverse reactions and develop a strategy to help prevent such problems in the future before the product is marketed again. The FDA will convene an independent scientific advisory committee to thoroughly evaluate all available data.
Q: Has Fort Dodge cooperated with CVM in the review of this product?
A: Yes. As of September 10, 2004, Fort Dodge submitted the more than 5,500 adverse event reports in compliance with federal regulations (21 CFR §514.80) that require sponsors to submit serious and unexpected adverse drug events within 15 working days of first receiving the information. Fort Dodge has worked with CVM to make label revisions to include post approval safety information including rare reports of death and a caution to practitioners that dogs should have a negative test for heartworm before administration. The firm has also added a Client Information Sheet, and issued two “Dear Doctor” letters to advise veterinarians and pet owners of the risks associated with use of the product. Also, after consultations with CVM, the company agreed to recall the product.
Q: ProHeart®6 is used in other countries. Are they experiencing problems?
A: We have only sketchy data from other countries, so we cannot answer that with any certainty. We want to point out, though, that ProHeart®6 adverse reactions, while many times severe, occur in only a small percentage of treated animals. Whether other countries see reactions may depend on the number of doses given.
Q: What more can you tell us about the advisory committee that will review the product?
A: The Veterinary Medicine Advisory Committee is made up of various independent scientists who will be asked to evaluate data about the product. No other details about the committee or the meeting dates are available.
Q: My veterinarian just gave my dog a shot of ProHeart®6 before the recall. Why didn’t he know that the product was dangerous?
A: Although we have had concerns about ProHeart®6 for several months, it remains an approved product. Therefore, your veterinarian was acting in a completely legal manner when he treated your dog. And neither CVM nor ProHeart®6’s sponsor, Fort Dodge Animal Health, issued any statement saying that the drug was not safe prior to the voluntary recall.
The product has produced severe side effects in a limited number of dogs. So most dogs treated with it will not demonstrate any adverse reaction. Nonetheless, because the cause of the problems associated with ProHeart® 6 have not been identified or remedied, and because veterinarians and dog owners have effective alternative heartworm products available to them, CVM believes that removing the product from the market is in the best interest of the dogs and their owners.
The drug manufacturer, Fort Dodge Animal Health, has agreed to voluntarily recall the product.
Q: My dog seems to be having or has had a reaction to ProHeart®6. Should I file a report with you about that?
A: First, return to your veterinarian and ask him or her to file a report for you. If he or she won’t, you can file a report by going to CVM’s website (<A href="[ioID]1FB93986303A443E810AF23E7CBE7C4A) and go to the Adverse Drug Experience page where you will find a form to use in reporting to FDA. Or you can call 1-888-FDA-VETS to file your report.
Q: When will I hear back from CVM about my report?
A: You will not hear back from CVM. The reports are analyzed by experts at the Center, and the results are entered into a database. You can view data generated from the database on CVM’s Website.
Q: My dog has received an injection. What side effects might occur from ProHeart®6, how soon will I see them and how long should I monitor my dog?
A: The side effects that are observable to dog owners that have been reported in association with ProHeart® 6 are anorexia (loss of appetite); lethargy; vomiting; neurologic signs, such as seizures, difficulty walking and reports of blindness; jaundice (a yellowish appearance); and bleeding disorders. Most of these observable clinical signs have occurred within one month of receiving the drug.
Q: If my dog does have an abnormality (adverse reaction), how should he be treated?
A: A thorough veterinary examination including a routine complete blood count and serum chemistry should reveal most problems. There is no specific antidote for the adverse effects of ProHeart®6. Supportive care according to the system and abnormality detected is indicated. Your veterinarian is the best source of treatment advice. Treatment will depend upon the organ system affected and the severity of the abnormality.
Q: My dog got sick or died after an injection. What should I do?
A: Have your veterinarian file an adverse drug experience report with the company or directly with the FDA.
From a Veterinarian’s Perspective:
Q: I have had more problems with vaccines. I do not understand why ProHeart®6 is being singled out?
A: CVM does not regulate vaccines. The UDSA monitors adverse drug reactions in vaccines and it is a voluntary, not a mandatory manufacturer reporting process. Vaccines do not receive the same scrutiny as drugs. The testing requirements are different. A more appropriate comparison would be ProHeart®6 and other heartworm preventatives that go through a pre-approval process at FDA.
Q: Every drug has some side effect or reactions. Why is ProHeart®6 any different?
A: It is true that all drugs have some side effects. Many of the adverse drug experiences associated with ProHeart®6 involve serious, life-threatening adverse events, such as anaphylaxis, convulsions, hematopoetic disorders and heptopathies followed, in some instances, by death. CVM has also evaluated reports that include neurologic problems and, unusual cardiac signs. If the adverse drug events ended at transient anaphylaxis or other mild sign, CVM would not have requested FDAH to initiate a recall. Second, ProHeart®6 is a sustained release product which, if dosed according to the label, is never withdrawn from the system.
Q: Was the recall of ProHeart®6 the result of media hype and done at the spur of the moment?
A: No, CVM has evaluated the adverse drug events over the past several years, worked very hard at obtaining accurate follow up information, and all of this information has originated in veterinary hospitals and been reported through the manufacturer to FDA. CVM was concerned about this product before the media became aware of the concerns and had already required three label changes and informed the company that they were concerned about the liver and autoimmune signs and were watching those reports carefully. All of this occurred before March of 2003 when the media became aware them.
Q: I have not had any more problems with ProHeart®6 than other heartworm preventatives in my clinic. How do you explain this fact?
A: There are over 5000 reports of veterinarians who have had a problem with ProHeart®6.
Q: Why were veterinarians not consulted in the decision to remove this product from the market?
A: The decision to remove a product from the market is between FDA and the manufacturer. FDA made the recommendation based on veterinary reporting to the manufacturer in at least 5000 instances.
For Immediate Release
VETERINARY MEDICINE ADVISORY COMMITTEE
REVIEWS DATA ON PROHEART 6
OVERLAND PARK, Kan. (January 31, 2005) – Fort Dodge Animal Health, a division of Wyeth
(NYSE: WYE), announced today that the Veterinary Medicine Advisory Committee (VMAC) did not reach a consensus regarding its review of safety data for ProHeart® 6. The committee commented on the breadth and complexity of the data presented today and difficulty in drawing firm conclusions. The VMAC is the advisory committee to the Food and Drug Administration’s Center for Veterinary Medicine (CVM).
“Fort Dodge Animal Health will continue to work closely with the CVM to resolve any remaining concerns with the product,” said Rami Cobb, Vice President of Pharmaceutical Research and Development for Fort Dodge Animal Health. “We feel strongly the thorough testing, comprehensive analysis of the related data and findings of independent scientific experts have demonstrated ProHeart 6 is safe and effective.”
During today’s advisory committee meeting, the panel heard and deliberated on product data presented by Fort Dodge Animal Health, an expert veterinary epidemiologist and representatives from the CVM. Fort Dodge’s presentation focused on the results of an extensive and rigorous review of ProHeart 6, and included the evaluations and conclusions of independent scientific experts.
Lawrence Glickman, VMD, DrPh, FACE, Professor of Epidemiology and Public Health, and Head of the Clinical Epidemiology Section, School of Veterinary Medicine, Purdue University, analyzed data from nearly seven million canine visits at more than 400 hospitals in the Banfield, The Pet Hospital® practice. Dr. Glickman’s presentation to VMAC, which was based on thorough evaluation of these data, concluded the safety profile of ProHeart 6 appeared similar to two commonly used monthly oral heartworm preventatives, and the results of this study provided no support for the recall of ProHeart 6 from the veterinary market.
“Based on thorough testing of the product and comprehensive analysis of the related data, we are confident in the safety and efficacy of ProHeart 6 and believe it has proven to be of significant benefit to both veterinarians and pet owners in the prevention of potentially deadly heartworm disease,” said Cobb.
Fort Dodge Animal Health, a division of Wyeth (NYSE: WYE), is a leading manufacturer and distributor of prescription and over-the-counter animal health care products for the livestock, companion animal, equine, swine and poultry industries in North America and international markets. Key products include West Nile-Innovator®, CYDECTIN® Pour-On, Duramune® Adult,
QUEST® Gel and EtoGesic® Tablets. The company is headquartered in Overland Park, Kan.
May my beloved partner ROMI rest in peace - no matter wherever her bits and pieces/frozen carcass may be held hostage.