HOME: THE JOHN LAVERTY, JR. CASE-- FALSE SBS CHARGES, WRONGFUL CONVICTION & IMPRISONMENT

THE "SHAKEN BABY SYNDROME" MYTH: Why top scientists say it isn't possible to shake an infant hard enough to cause the symptoms used to diagnose SBS and the probable real causes

Casey Laverty was born on Nov.20th, 2000. Her mother hemorrhaged for 2 days after giving birth, prior to which she lived on a diet of small amounts of junk food, coffee, excessive sugar, no pre-natal vitamins, and she smoked before, during and after giving birth. Casey had abnormally swollen cheeks and a rolly-poly appearance in spite of a 10lb weight gain by her mother during the pregnancy. The mother, Melissa was unable to breast feed and pumped milk in scanty amounts. According to John, the father, someone came in to vaccinate the baby the next day (21st) with Hep B (according to the records) but he heard them say "triple vax". He refused the shot due to known adverse reactions, but was falsely told, "You have no choice, it's the law." No warning on possible reactions was provided, as required by law. Two days later, according to the mother, on Thanksgiving Day ("corrected" pediatric records claim it was on the 24th), Casey had been lethargic and wouldn't take her bottle when she gave a cry. John picked her up and her eyes rolled back in her head and she seemed to stop breathing temporarily. He noted a yellow tint to her skin and bluishing tinge around her mouth. She didn't respond to voice or finger-snapping near her face, so the parents took her to the E.R. at Mary Bridge Hospital.

 

sepsis

Sepsis refers to bacterial infection of the bloodstream. It means that the normal defenses of the body against overwhelming infection are breaking down and bacterial germs are loose and multiplying in the bloodstream. Once this state has arisen, the patient&/39;s chances for recovery begin to dwindle rapidly. Sepsis is a medical emergency requiring swift and decisive intervention. Septic shock and death will follow if this condition is left untreated for long.

For this reason, that the consequences of missing sepsis are so dire, and because the early signs of sepsis may be quite subtle, physicians often perform what is referred to as the "septic workup," which means obtaining culture specimens of blood, urine, and spinal fluid (via lumbar puncture or spinal tap). While awaiting these test results, powerful antibiotics are administered intravenously in high doses until the situation is more clear - whether the patient is truly gravely infected or perhaps suffering from another illness, often viral, which is not serious.

Most septic workups are performed on very young infants, because these children in particular are the most difficult to assess on clinical grounds (physical examination, history or presence of fever, and routine lab tests such as blood count). Most septic workups are false alarms, but they are a small price to pay for saving young lives.

http://www.drhull.com/EncyMaster/G/grunting.html

Sick children

The grunting of sick persons is different from the occasional grunt of the happy, healthy child. Grunting caused by illness is more regular, often with every breath. The child usually appears to be in some distress or to be ill. Grunting respirations in a baby with a fever or who appears to be sick is a very bad sign and demands immediate emergency medical attention. The grunting respirations could represent

* pneumonia
* asthma or in a baby, bronchiolitis with significant oxygen lack - look out for a blue coloration around the lips - cyanosis
* sepsis
* meningitis
* heart failure with flooding of the lungs with fluid, in a child either known to have heart disease or previously undiagnosed

http://www.emedicine.com/PED/topic2033.htm

Caution with hypersensitivity to penicillin; adjust dosage in patients with renal impairment; may cause neutropenia, thrombocytopenia, eosinophilia, positive Coombs test, and elevated BUN, creatinine, and liver enzymes

http://www.druglib.com/druginfo/claforan/side-effects/

Local (4.3%): Injection site inflammation with IV administration. Pain, induration, and tenderness after IM injection.

Hypersensitivity (2.4%): Rash, pruritus, fever, eosinophilia and less frequently urticaria and anaphylaxis.

Gastrointestinal (1.4%): Colitis, diarrhea, nausea, and vomiting.

Symptoms of pseudomembranous colitis can appear during or after antibiotic treatment.

Nausea and vomiting have been reported rarely.

Less frequent adverse reactions (less than 1%) are:

Cardiovascular System: Potentially life-threatening arrhythmias following rapid (less than 60 seconds) bolus administration via central venous catheter have been observed.

Hematologic System: Neutropenia, transient leukopenia, eosinophilia, thrombocytopenia and agranulocytosis have been reported. Some individuals have developed positive direct Coombs Tests during treatment with CLAFORAN and other cephalosporin antibiotics. Rare cases of hemolytic anemia have been reported.

Genitourinary System: Moniliasis, vaginitis.

Central Nervous System: Headache.

Liver: Transient elevations in SGOT, SGPT, serum LDH, and serum alkaline phosphatase levels have been reported.

Kidney: As with some other cephalosporins, interstitial nephritis and transient elevations of BUN and creatinine have been occasionally observed with CLAFORAN.

Cutaneous: As with other cephalosporins, isolated cases of erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported.

In addition to the adverse reactions listed above which have been observed in patients treated with cefotaxime sodium, the following adverse reactions and altered laboratory tests have been reported for cephalosporin class antibiotics: allergic reactions, hepatic dysfunction including cholestasis, aplastic anemia, hemorrhage, and false-positive test for urinary glucose.

Ceftriaxone Adverse Reactions

http://www.bbraunusa.com/images/bbraun_usa/cef_brief_summary.pdf

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including ceftriaxone, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.

Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of "antibiotic-associated colitis". After the diagnosis of pseudomembranous colitis has been established, appropriate therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis.

Ceftriaxone for Injection and Dextrose Injection should not be administered to hyperbilirubinemic neonates, especially prematures.LOCAL REACTIONS—Phlebitis was reported in <1% after IV administration.

HYPERSENSITIVITY—rash (1.7%). Less frequently reported (<1%) were pruritus, fever or chills.

HEMATOLOGIC—eosinophilia (6%), thrombocytosis (5.1%) and leukopenia (2.1%). Less frequently reported (<1%) were anemia, hemolytic
anemia, neutropenia, lymphopenia, thrombocytopenia and prolongation of the prothrombin time.

GASTROINTESTINAL—diarrhea (2.7%). Less frequently reported (<1%) were nausea or vomiting, and dysgeusia. The onset of
pseudomembranous colitis symptoms may occur during or after antibacterial treatment (see WARNINGS).

HEPATIC—elevations of SGOT (3.1%) or SGPT (3.3%). Less frequently reported (<1%) were elevations of alkaline phosphatase and bilirubin.

RENAL—elevations of the BUN (1.2%). Less frequently reported (<1%) were elevations ofcreatinine and the presence of casts in the urine.

CENTRAL NERVOUS SYSTEM—headache or dizziness were reported occasionally (<1%).

GENITOURINARY—moniliasis or vaginitis were reported occasionally (<1%).

MISCELLANEOUS—diaphoresis and flushing were reported occasionally (<1%).

Other rarely observed adverse reactions (<0.1%) include abdominal pain, agranulocytosis, allergic pneumonitis, anaphylaxis, basophilia, biliary lithiasis, bronchospasm, colitis, dyspepsia, epistaxis, flatulence, gallbladder sludge, glycosuria, hematuria, jaundice, leukocytosis, lymphocytosis, monocytosis, nephrolithiasis, palpitations, a decrease in the prothrombin time, renal precipitations, seizures, and serum sickness.

http://www.hc-sc.gc.ca/dhp-mps/medeff/bulletin/carn-bcei_v15n1_e.html#6

Canadian Adverse Reaction Newsletter, Volume 15 . Issue 1 . January 2005
Health Products and Food Branch, Marketed Health Products Directorate

Ceftriaxone (Rocephin) and immune hemolytic anemia in children

Ceftriaxone (Rocephin), marketed in Canada since Dec. 31, 1987, is a third-generation cephalosporin indicated for the treatment of susceptible strains of bacteria, as well as for prophylaxis against infections in patients undergoing hysterectomy, coronary artery bypass surgery or biliary tract surgery.1 Immune hemolytic anemia (IHA) is a hypersensitivity adverse reaction (AR) known to occur in adults and children. The Rocephin product monograph describes autoimmune hemolytic anemia as a rare AR (< 0.1% of cases),1 but does not mention IHA.

Ceftriaxone antibodies appear to be induced by an immune complex mechanism during a sensitization phase after initial exposure to the drug. 2 Intravascular hemolysis may be triggered after subsequent re-exposure. The signs and symptoms of drug-induced IHA include severe hemolytic anemia, hemoglobinuria, hypotension, acute renal failure, fever and back pain.3

From Jan. 1, 1988, to Sept. 15, 2004, Health Canada received 1 report of acute hemolysis suspected of being associated with ceftriaxone. A young child with sickle cell disease had been given a single dose of ceftriaxone (80 mg/kg body weight) intravenously for fever and cough, and within 30 minutes developed a rash, pallor and decreased level of consciousness. Laboratory examination showed a positive direct Coomb's test result, a hemoglobin level of 7 g/L (the pre-infusion level was 110 g/L) and hemolyzed red blood cells. The following day, the patient died despite resuscitation attempts. The only concomitant medication was a single oral dose of erythromycin. The patient had been exposed to ceftriaxone in the past.

Nine pediatric cases of IHA associated with exposure to ceftriaxone were identified in the literature, 6 of which were fatal.4-12One child with sickle cell anemia received ceftriaxone on several occasions and experienced 6 episodes of unexplained transient hemoglobinuria before the onset of the IHA.10

Drug-induced IHA is associated with a high mortality rate.3 Other than supportive care and red blood cell transfusion, there are few effective treatment options. Reintroduction of the drug is contraindicated because of the high risk of recurrence of hemolysis, which is often more severe.3

IHA associated with ceftriaxone is rare and has been reported to occur with repetitive, intermittent use of this drug. Children with underlying conditions such as hemoglobinopathies and immunodeficiencies are likely to require frequent treatment or prophylaxis with ceftriaxone, which may place them at increased risk of IHA. The development of signs and symptoms of IHA, including hemoglobinuria or unexplained anemia, should prompt health care professionals to consider this diagnosis and the discontinuation of the suspect drug.3

Lise Watters, MD, FRCPC; Debra Willcox, BSP, Health Canada

http://www.docguide.com/news/content.nsf/news/852571020057CCF6852573100075672D
Rocephin (Ceftriaxone Sodium) - Contraindications, Warnings, Precautions, Adverse Reactions, Dosage and Administration Sections of Labeling Revised

BETHESDA, MD -- July 6, 2007 -- Roche and FDA informed healthcare professionals of revisions to the Contraindications, Warnings, Precautions, Adverse Reactions and Dosage and Administration sections of the prescribing information for Rocephin for Injection.

The revisions are based on new information that describes the potential risk associated with concomitant use of Rocephin with calcium or calcium containing solutions or products. Cases of fatal reactions with calcium-ceftriaxone precipitates in the lungs and kidneys in both term and premature neonates were reported. Hyperbilirubinemic neonates, especially prematures, should not be treated with Rocephin.

The drug must not be mixed or administered simultaneously with calcium-containing solutions or products, even via different infusion lines. Additionally, calcium-containing solutions or products must not be administered within 48-hours of the last administration of ceftriaxone.

http://www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed&uid=2584749&cmd=showdetailview&indexed=google

1: J Infect Dis. 1989 Dec;160(6):1005-11.Links
Comment in:
J Infect Dis. 1990 Oct;162(4):991-3.
Cerebrospinal fluid endotoxin levels in children with H. influenzae meningitis before and after administration of intravenous ceftriaxone.
Arditi M, Ables L, Yogev R.

Department of Pediatrics, Children's Memorial Hospital, Northwestern University Medical School, Chicago, Illinois 60614.

Total, cell-free, and cell-bound endotoxin and bacterial density were measured in cerebrospinal fluid (CSF) of 22 children with Hemophilus influenzae meningitis. Also the effect of ceftriaxone on CSF endotoxin levels was investigated in eight patients by reexamining their CSF 2-6 h after the initial dose. Initial CSF bacterial density correlated with initial CSF endotoxin levels (P less than .001). Ceftriaxone induced a marked increase of free endotoxin in CSF, from an initial (mean +/- SE) 0.75 +/- 0.21 to 1.29 +/- 0.23 log10 ng/ml (P less than .01). This increase correlated positively with the number of bacteria killed in the CSF (P less than .01). The increase in free endotoxin was associated with an increase in mean CSF lactate levels from 8.5 to 9.7 units/l (P less than .05) and mean lactate dehydrogenase levels from 102 to 180 mmol/l (P less than .02) and a decrease in mean CSF glucose from 1.17 to 0.46 mmol/l (P less than .05). Initial CSF total endotoxin concentrations correlated both with the Herson-Todd clinical severity score (P less than .001) and with the number of febrile hospital days (P less than .001). These findings suggest that highly bactericidal agents initially lead to release of free endotoxin from gram-negative organisms into CSF, with associated enhanced inflammatory response by the host.

http://md1.csa.com/partners/viewrecord.php?requester=gs&collection=ENV&recid=
3962692&q=Ceftriaxone+%2B+endotoxin&uid=791990964&setcookie=yes

Different endotoxin release and IL-6 plasma levels after antibiotic administration in surgical intensive care patients
Holzheimer, RG; Hirte, JF; Reith, B; Engelhardt, W; Horak, KH; Leppert, R; Aasen, A; Capel, P; Urbaschek, R; Karch, H; Thiede, A
Journal of Endotoxin Research [J. ENDOTOXIN RES.]. Vol. 3, no. 3. 1996.

Despite the use of broad-spectrum antibiotics, aggressive fluid resuscitation, vasopressor support, the mortality associated with Gram-negative sepsis and septic shock has not decreased significantly in the last two decades. The consequences of host exposure to endotoxin and the relationship of antibiotic administration to endotoxin release have become important areas of intense interest. In vitro studies have demonstrated that there was a difference in endotoxin release between PBP-3 specific antibiotics ( beta -lactam antibiotics) and PBP-2 specific antibiotics (carbapenems). This is the first clinical report of surgical patients admitted to the surgical and anaesthesiology intensive care unit on the missing endotoxin release after imipenem treatment; however cefotaxime and ceftriaxone showed significantly more positive endotoxin tests in the plasma when compared to imipenem. Ciprofloxacin and vancomycin were intermediate in endotoxin release and tobramycin did not cause endotoxin release. There were also significant differences in endotoxin neutralizing capacity. IL-6 levels were decreased after imipenem faster than after ceftriaxone or cefotaxime; ciprofloxacin seemed to increase IL-6. Endotoxin may be harmful in patients where the immune system has been continuously challenged. Timing, dosage, or combination with other compounds as well as the effect of antibiotics on macrophages need to be tested in larger clinical trials. In this respect a consecutive study was started.