Case Narrative Including Clinical Course, Therapeutic Measures, Outcome and Additional Relevant Information Consumer report from the www.abbott.com of bad side effects coincident with ADALIMUMAB (HUMIRA PRE-FILLED SYRINGE) therapy. On an unknown date, the patient started HUMIRA PRE-FILLED SYRINGE therapy for an unknown indication. On an unknown date, the patient experienced bad side effects. Initial information was received from the mother of a 20 month old female child. The parent states she thinks the child may have accidentally ingested one or some amount of Zantac tablets of an unspecified dosage, on an unspecified date. The lot number, expiration date, or treatment for the event was not reported. Concomitant medications and medical history were not reported. It was not reported if Zantac was discontinued or if the patient has recovered Note, this text pastes together info from two separate reports. Sample Autopsy Report SUMMARY OF CLINICAL HISTORY: The patient was a 35 year old African American male with no significant past medical history who called EMS with shortness of breath and chest pain. Upon EMS arrival, patient was tachypneic at 40 breaths per minute with oxygen saturation of 90%. At the scene, EMS administered breathing treatments and checked lung sounds that did not reveal any evidence of fluid in the lung fields. EMS also reports patient was agitated upon their arrival at his residence. Two minutes after arrival at UTMB at 1500, the patient became unresponsive, apneic, and had oxygen saturations from 80-90%. The patient’s heart rate decreased to asystole, was intubated with good breath sounds and air movement. Patient then had wide complex bradycardia and ACLS protocol for pulseless electrical activity was followed for 45 minutes. The patient was administered TPA with no improvement. Bedside echocardiogram showed no pericardial effusion. The patient was administered D5W, Narcan, and multiple rounds of epinephrine and atropine, calcium chloride, and sodium bicarbonate. The patient had three episodes of ventricular trachycardia/fibrillation with cardioversion/defibrillation resulting in asystole. The patient was pronounced dead at 1605 with fixed, dilated pupils, no heart sounds, no pulse and no spontaneous respirations. DESCRIPTION OF GROSS LESIONS: EXTERNAL EXAMINATION: The body is that of a 35 year old well developed, well nourished male. There is no peripheral edema of the extremities. There is an area of congestion/erythema on the upper chest and anterior neck. There are multiple small areas of hemorrhage bilaterally in the conjunctiva. A nasogastric tube and endotracheal tube are in place. There is an intravenous line in the right hand and left femoral region. The patient has multiple lead pads on the thorax. The patient has no other major surgical scars. INTERNAL EXAMINATION (BODY CAVITIES): The right and left pleural cavity contains 10 ml of clear fluid with no adhesions. The pericardial sac is yellow, glistening without adhesions or fibrosis and contains 30 ml of a straw colored fluid. There is minimal fluid in the peritoneal cavity. HEART: The heart is large with a normal shape and a weight of 400 grams. The pericardium is intact. The epicardial fat is diffusely firm. As patient was greater than 48 hours post mortem, no TTC staining was utilized. Upon opening the heart was grossly normal without evidence of infarction. There were slightly raised white plaques in the left ventricle wall lining. The left ventricle measures 2.2 cm, the right ventricle measures 0.2 cm, the tricuspid ring measures 11 cm, the pulmonic right measures 8 cm, the mitral ring measures 10.2 cm, and the aortic ring measures 7 cm. The foramen ovale is closed. The circulation is left dominant. Examination of the great vessels of the heart reveals minimal atherosclerosis with the area of greatest stenosis (20% stenosis) at the bifurcation of the LAD. AORTA: There is minimal atherosclerosis with no measurable plaques along the full length of the ascending and descending aorta. LUNGS: The right lung weighed 630 grams, the left weighed 710 grams. The lung parenchyma is pink without evidence of congestion of hemorrhage. The bronchi are grossly normal. In the right lung, there are two large organizing thrombo-emboli. The first is located at the first branch of the pulmonary artery with an older, organizing area adherent to the vessel wall measuring 1.0 x 1.0 x 2.5 cm. Surrounding this organizing area is a newer area of apparent thrombosis completely occluding the bifurcation. The other large organizing, adherent embolus is located further in out in the vasculature measuring approximately 1.0 x 1.0 x 1.5 cm. There are multiple other emboli located in smaller pulmonary vessels that show evidence of distending the vessels they are located inside. GASTROINTESTINAL SYSTEM: The esophagus and stomach are normal in appearance without evidence of ulcers or varices. The stomach contains approximately 800 ml, without evidence of any pills o other non food stuff material. The pancreas shows a normal lobular cut surface with evidence of autolysis. The duodenum, ileum, jejunum and colon are all grossly normal without evidence of abnormal vasculature or diverticuli. An appendix is present and is unremarkable. The liver weighs 2850 grams and the cut surface reveals a normal liver with no fibrosis present grossly. The gallbladder is in place with a probe patent bile duct through to the ampulla of Vater. RETICULOENDOTHELIAL SYSTEM: The spleen is large weighing 340 grams, the cut surface reveals a normal appearing white and red pulp. No abnormally large lymph nodes were noted. GENITOURINARY SYSTEM: The right kidney weighs 200 grams, the left weighs 210 grams. The left kidney contains a 1.0 x 1.0 x 1.0 simple cyst containing a clear fluid. The cut surface reveals a normal appearing cortex and medulla with intact calyces. The prostate and seminal vessels were cut revealing normal appearing prostate and seminal vesicle tissue without evidence of inflammation or embolus. ENDOCRINE SYSTEM: The adrenal glands are in the normal position and weigh 8.0 grams on the right and 11.6 grams on the left. The cut surface of the adrenal glands reveals a normal appearing cortex and medulla. The thyroid gland weighs 12.4 grams and is grossly normal. EXTREMITIES: Both legs and calves were measured and found to be very similar in circumference. Both legs were also milked and produced no clots in the venous system. CLINICOPATHOLOGIC CORRELATION This patient died shortly after a previous pulmonary embolus completely occluded the right pulmonary artery vasculature. The most significant finding on autopsy was the presence of multiple old and new thromboemboli in the pulmonary vasculature of the right lung. The autopsy revealed evidence of multiple emboli in the right lung that were at least a few days old because the emboli that were organizing were adherent to the vessel wall. In order to be adherent to the vessel wall, the emboli must be in place long enough to evoke a fibroblast response, which takes at least a few days. The fatal event was not the old emboli in the right lung, but rather the thrombosis on top of the large saddle thrombus residing in the pulmonary artery. This created a high pressure situation that the right ventricle could not handle resulting in cardiac dysfunction and ultimately the patient’s demise. Although this case is fairly straight forward in terms of what caused the terminal event, perhaps the more interesting question is why a relatively healthy 35 year old man would develop a fatal pulmonary embolism. Virchow’s triad suggests we should investigate endothelial injury, stasis and a hypercoaguable state as possible etiologies. The age of the patient probably precludes venous stasis as the sole reason for the embolus although it could have certainly contributed. The autopsy revealed no evidence of endothelial damage in the pulmonary vasculature that would have caused the occlusion. The next logical reason would be a hypercoagulable state. Some possibilities include obesity, trauma, surgery, cancer, Factor V Leiden deficiency (as well as other inherited disorders-prothrombin gene mutation, deficiencies in protein C, protein S, or antithrombin III, and disorders of plasminogen), and Lupus anticoagulant. Of these risks factors, obesity was the only risk factor the patient was known to have. The patient had no evidence of trauma, surgery, cancer or the stigmata of SLE, therefore these are unlikely. Perhaps the most fruitful search would be an examination of the genetic possibilities for a hypercoaguable state (Factor V Leiden being the most common). In summary, this patient died of a pulmonary embolism, the underlying cause of which is currently undetermined. A definitive diagnosis may be ascertained with either genetic or other laboratory tests and a more detailed history. SUMMARY AND REFLECTION: What I learned from this autopsy: I learned that although a cause of death may sometimes be obvious, the underlying mechanism for the death may still be elusive. This patient was an otherwise completely healthy 35 year old man with one known risk factor for a hypercoaguable state. Remaining unanswered questions: Basically the cause of the hypercoaguable state is undetermined. Once that question is answered I believe this autopsy will have done a great service for the patient’s family. Medication Information Why is this medication prescribed? . Erythromycin is an antibiotic used to treat certain infections caused by bacteria, such as bronchitis; diphtheria; Legionnaires' disease; pertussis (whooping cough); pneumonia; rheumatic fever; venereal disease (VD); and ear, intestine, lung, urinary tract, and skin infections. It is also used before some surgery or dental work to prevent infection. Antibiotics will not work for colds, flu, or other viral infections. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information. How should this medicine be used? . Erythromycin comes as a capsule, tablet, long-acting capsule, long-acting tablet, chewable tablet, liquid, and pediatric drops to take by mouth. It usually is taken every 6 hours (four times a day) or every 8 hours (three times a day) for 7 to 21 days. Some infections may require a longer time. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take erythromycin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Shake the liquid and pediatric drops well before each use to mix the medication evenly. Use the bottle dropper to measure the dose of pediatric drops. The chewable tablets should be crushed or chewed thoroughly before they are swallowed. The other capsules and tablets should be swallowed whole and taken with a full glass of water. Continue to take erythromycin even if you feel well. Do not stop taking erythromycin without talking to your doctor. What special precautions should I follow? Return to top . Before taking erythromycin, •tell your doctor and pharmacist if you are allergic to erythromycin, azithromycin (Zithromax), clarithromycin (Biaxin), dirithromycin (Dynabac), or any other drugs. •tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially other antibiotics, anticoagulants ('blood thinners'), astemizole (Hismanal), carbamazepine (Tegretol), cisapride (Propulsid), clozapine (clozaril), cyclosporine (Neoral, Sandimmune), digoxin (Lanoxin), disopyramide (Norpace), ergotamine, felodipine (Plendil), lovastatin (Mevacor), phenytoin (Dilantin), pimozide (Orap), terfenadine (Seldane), theophylline (Theo-Dur), triazolam (Halcion), and vitamins. •tell your doctor if you have or have ever had liver disease, yellowing of the skin or eyes, colitis, or stomach problems. •tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking erythromycin, call your doctor. •if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking erythromycin. What special dietary instructions should I follow? Return to top . Take erythromycin at least 1 hour before or 2 hours after meals. Do not take this medication with, or just after, fruit juices or carbonated drinks. Certain brands of erythromycin may be taken with meals; check with your doctor or pharmacist. What should I do if I forget a dose? Return to top . Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one. . The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program co-sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS is a post-marketing safety surveillance program, collecting information about adverse events (possible side effects) that occur after the administration of vaccines licensed for use in the United States. VAERS provides a nationwide mechanism by which adverse events following immunization may be reported, analyzed, and made available to the public. VAERS also provides a vehicle for disseminating vaccine safety-related information to parents and guardians, health care providers, vaccine manufacturers, state vaccine programs, and other constituencies. Author (last name first), "Article Title." Name of newspaper, city, state of publication. (date): edition if available, section, page number(s). Mr. John James Doe 124 Any Street Apt. 4 Center City AL 12345 Ms. Jane S Doe This is what we thought Further relevant comments Systems Review 1.Constitutional: energy level generally good, weight is stable at 160 lbs, height 5’8” 2.HEENT: No headaches Eyes: wears reading glasses but thinks vision getting is worse, no diplopia or eye pain Ears: hearing loss for many years, wears hearing aid now Nose: no epistaxis or obstruction No history of tonsillitis or tonsillectomy Wears full set of dentures for more than 20 years, works well. 3.Respiratory: No history of pleurisy, cough, wheezing, asthma, hemoptysis, pulmonary emboli, pneumonia, TB or TB exposure 4.Cardiac: See HPI 5.Vascular: No history of claudication, gangrene, deep vein thrombosis, aneurysm. Has chronic venous stasis skin changes for many years 6.G.I.: Admitted to CPMC in 1980 after two days of melena and hematemesis. Upper G.I. series was negative but endoscopy showed evidence of gastritis, presumed to be caused by ibuprofen intake. Her hematocrit was 24% on admission and she received four units of packed cells. Colonoscopy revealed multiple diverticuli. Since then her stool has been brown and consistently hematest negative when checked in clinic. Several months after this admission she was noted to be mildly jaundiced and had elevated liver enzymes, at this time it was realized that she contracted hepatitis B from the transfusions. Since then she has not had any evidence of chronic hepatitis. Molds, Rusts and Smuts, Penicillium notatum Penicillium notatum Guaifenesin, Dextromethorphan Generic name Acme Improve Generic name Profound Study Comment The condition was accentuated by poor diet. The patient's medical history does not show anything very out of the ordinary. ACCURETIC Spine and Nerve Balance Core Formula Deseret Homeopathis 123444-AB INFLUENZA A VIRUS A/CALIFORNIA/7/2009(H1N1)-LIKE ANTIGEN (FORMALDEHYDE INACTIVATED) ACME Production Corp. Progressive multifocal leukoencephalopathy Excessive Fibrosis What we learned during the autopsy Metabolic Abnormality consciência alterada Altered Consciousness Memorial Hospital Metropolis Pennsylvania Heart disease 123444-AB BCG vaccine ACME Production Corp. Calcium Level
These results may be skewed Blood work A special test The over all outcome was quite spectacular. exemestane Pharmacia and Upjohn Company Pharmacia and Upjohn Company Generic name Notabenazine Hydrochloride US unstructured dosing information, e.g. take by mouth 2 times a day with food Free text route content 4577BN2 Big, round and colored white Dr. Ralph Alexander Smith 24 Main St. Suite 2304 Metropolis ND012 ND 123245 USA Joseph Rabinowitz 24 Main St. Suite 2304 Metropolis ND 123245 USA 33 Main St. Pleasantville CA3435 CAlifornia 99999 Text to describe the route if needed more information on the next course Somthing seemed strange about the way it went down. Medication was prescribed to address sickness to the stomach. Aspirin Highly related Introspectioin Reporter 80% algorithm Company Likely Bayesean Company The reason Introspection Reporter It appears very likely that the primary drug is responsible for all the reactions. The condition came on suddenly, and was a complete surprise to the responsible clinicians. Estudo de caso Incluindo Curso Clínico, medidas terapêuticas, Resultado e informações adicionais relevantes Relatório do Consumidor do www.abbott.com de efeitos colaterais ruins coincidente com Adalimumabe (Humira SERINGA PRÉ-CHEIA) terapia. Em data desconhecida, o paciente começou HUMIRA terapia seringa pré-cheia para uma indicação desconhecida. Em um desconhecido data, a paciente apresentou efeitos colaterais ruins. A informação inicial foi recebida da mãe de uma criança do sexo feminino 20 meses de idade. Os estados de pais ela pensa a criança pode ter ingerido acidentalmente um ou uma certa quantidade de comprimidos Zantac de uma dose não especificada, em um data não especificada. O número de lote, data de validade, ou tratamento para o evento não foi relatado. concomitante medicamentos e história médica não foram relatados. Não foi referido que Zantac foi interrompido ou se o paciente recuperou Note-se, neste texto cola juntos informações de dois relatórios separados. 123 Main St. Anytown State of Residence 87654 Dr. Jerome James Jacobs Reporting Pharma Company 89 Central Ave Anytown Idaho 01340 Professor Ronald Robert Rhodes Reporting Medium Size Pharma 49 Main St. Anytown CT 23456 Mr Charles Castile Conner Management Big Pharma A text reason for ammending the document