Saturday, June 4, 2011

FDA Clinical Summary Review of Pediatric Metabolic Adverse Events 5 Atypical Antipsychotics:Seroquel -48 adverse events, 5 deaths, 36 kids developed/experienced diabetes

      Destiny Hager dead @Age 3                                                            Rebecca Riley dead @Age 4

FDA Clinical Summary Review of Pediatric Metabolic Adverse Events 5 Atypical Antipsychotics:Seroquel -48 adverse events, 5 deaths, 36 kids developed/experienced diabetes

 We are destroying our children in the name of corporate profits & greed...We are burying children in the name of egocentric false medicine concerned more with reputations, money, or status; than with the lives they have sworn an oath to care for.

DO NO HARM

Remember these are just a few of the reported adverse events in 2008-2009. There is little doubt thousands upon thousands of children are suffering the horrible and debilitating side effects of seroquel and like drugs today as these words are being typed.

There are not names next to these statistics listed below; but these are very real children...they could be your neighbors children, a relatives child, a friends child, they could be poor or foster children; and they all have something in common, they have names...they are America's children.

Read what these very young kids & toddlers are being given...it's disturbing and beyond all rational comprehension....

FDA Clinical Summary Review of Pediatric Metabolic Adverse Events 5 Atypical Antipsychotics

Summary Table: Clinical Review of Serious and Non-serious Pediatric Metabolic Adverse Event (AE)
Reports for 5 Atypical Antipsychotic Drugs from FDA AERS Database 1-Year Time period: 9/1/08-8/31/09
Metabolic Adverse Events
Seroquel (quetiapine fumarate)
48
20 Males
28 Females
6-17 years
5 deaths (no causal association reported)
13 reports weight gain with specific mention of weight gain
36 reports stating child developed/experienced or had diabetes
1 underwent gastric bypass surgery
---------------------------------------------------------------

Seroquel (quetiapine) Metabolic Adverse Events (n=48)

11yo F Death
Anxiety and ADHD
Death. BMI 28.3. Seroquel treatment started in 2001. 5/5/03 Patient died of complications of DM & DKA.
methylphenidate, prednisolone, amoxicillin, termazepam, clonidine, burpropion, diphenhydramine, ibuprofen, cyclobenzaprine

16yo M
Death
Seroquel as sleep aid
Death. Patient experienced DM and pancreatitis in 1/1981 (prior to marketing of Seroquel) DKA 4/05 neuropathy and death (no date reported) male with PMH DM 1, hypertension, hepatitis C, iv drug abuse, recurrent pancreatitis, respiratory distress, bilateral strokes, hypercholesterolemia, arthritis, hypothyroid, cerebritis, Took Seroquel for sleep aid 4/4/5. History psych disorder confusion episodes, argumentativeness, combativeness,
lonazepam, pantoprazole, clonidine, simvastatin, citalopram, metoprolol, insulin, senna, hydralzine, lorazepam, ketorolac, tromethamine, lisinopril, ASA

16yo F
Death
Aggression history of autism, obesity & violent outbursts
Death Patient developed DM and diabetes-related conditions. Patient died due to shock, DKA, pancreatitis and tardive dyskinesia. Hospitalized in 9/04 with pain, vomiting, hi blood glucose. Discontinued with DKA. Blood Glucose 990, info died due to pancreatitis, DKA, shock. Autopsy revealed new onset diabetes, DKA, pulmonary congestion & edema, hepatomegaly with metamorphosis, Seizure episode. PMH Landau-Kleffner syndrome, autistic disorder, severe MR, near global aphasia, intermittent constipation probably related to dietary factors, encopresis, chronic sleep difficulties, weight gain, and premenstrual syndrome with rage behaviors.
clonidine, sertraline, diazepam

15yo F
Death
Depression, agitation, somnolence, tremor, dyskinesia
Death Patient began Seroquel 12/05 and within 8 months found dead on bedroom floor. Autopsy revealed death from possible fatal heart arrhythmia. No prior cardiovascular disease. After suicidal gesture, Dr increased dose and Patient became increasingly agitated, gained 50lbs, experienced neck rigidity, tremor in hands, uncontrollable movements & weakness.
NI

15yo M
Death
OCD, behavior concerns, Chiari Malformation, and possible history of PANDAS
Death. For at least several months after lithium started months recently. 3d history of respiratory symptoms, muscle rigidity, dysphasia and confusion. 1/18/09 Patient difficult to arouse. 911 call and taken to ER. Intubated and respiratory failure. Symptoms of hyperglycemia, rash, prolonged QT, hypotension & hyperthermia. Presumed diagnosis of neuroleptic malignant syndrome. Patient suffered severe HIE, brain function deteriorated and Patient died.
quetiapine, fluvoxamine, lithium

6yo M
ADHD, Bipolar & OCD
PMH hyperglycemia treated in 2000, BMI=35.9 AEs considered non-serious; developed DM & hyperglycemia. PMH liver, high cholesterol, thyroid, depression, ADHD, obesity
clonidine cefprozil

7yo M
Bipolar Disorder and Depression Affective Disorder
Alleged that patient developed DM from Seroquel.
Risperidal, Abilify

8yo F
Bipolar Disorder
Grandmother reports that 8yo treated with Seroquel and became lethargic weight gain 4-5 lbs in a month
Trileptal, Seroquel, Benadryl

8yo F
Hosp
Mood disorder
History of depression, bipolar disorder, ADHD. BMI 21.5. history of pulmonic stenosis, ASD, treatment for this age 2 yrs. Started Seroquel treatment 3/30/04 then on 4/27/04 to ER for suicidal ideation. 2/6//06 hosp & DM 1 discharged with blood sugar 304 mg/dl, urine glucose >1000mg/dl
risperidone, topiramate, fluoxetine

9yo M
NI
Patient had significant hallucinations, being touched hearing voices, seeing things, paranoia. Urinating on floor while sleeping. Violent outburst and disruptive behavior. Severe panic attacks. Significant weight gain. Suicide Ideation
NI

11yo M
Depression, Anxiety
Seroquel started 2003 experienced DM and DKA Also Bell’s Palsy.
NI

11yo M
Bipolar Disorder
Seroquel began 4/9/09 Patient experienced hypertension
amphetamine, clonidine

12yo F
Schizophrenia, Depression, Bipolar Disorder
Seroquel began 7/04 and developed DM in ’05 and Patient developed obesity, DM and pancreatitis in ’06.
ziprasidone

12yo F
Bipolar disorder psychosis and mood stability
Seroquel for bipolar Patient treated Seroquel dose 25-1400 mg for psychosis and mood stability. 2003 attempt suicide, DM II started in 2006 and weight gain in 2005. Medical records reveal earliest 10/02 and stop 7/06 confirmed in med records. Multiple hosp 2004-06 for aggression, suicidal risk, psychosis, in 5/06 borderline prolonged QT
risperidone, aripiprazole and ziprasidone, oxcarbazepine, lamotrigine, Adderall, valproate, methylphenidate, clonidine, dexmhethylphenidate, oloanzapine, trazodone, bupropion. lithium, lorazepam

12yo F
Hosp
NI
Stated 4/04 began treatment and developed DM 2/05. Hospitalized for DM and hypothyroid in 2/05. BMI 18.9. In 2005 treated for diabetic coma and DKA. DM I and Hashimoto’s thyroiditis.
sertraline, escitalopram, topiramate.

12yo F
Bipolar Disorder, with psychotic features, ODD Mild MR
Developed DM and related illnesses. BMI 27.4; medical records give history of being on Seroquel 10/97 developed illness ’99. suicidal, etc History of bipolar, paranoia, depression
NI

12yo F
Bipolar Disorder and Depression
BMI is 53.8; DM, obesity and Neuroleptic Malignant Syndrome started in 2001. Treatment then stopped. Medical records indicate DM I and psychosis NOS. morbid obesity
Abilify, clozapine, ziprasidone, haldol, risperidone, chlorpormazine, olanzapine

12yo M
Basal Ganglion Degeneration
Mom sends in report, son gained ~10lbs a month, with high liver count and in 2007 diagnosed with thyroid disorder. Dr discharged him with Basal Ganglia was taking lithium and Seroquel at same time and was overdosed at Strong Memorial Hospital last year.
lithium

12yo M
Bipolar Disorder, ADHD
Patient treated with Seroquel for ~8years takes Seroquel at night. 9/08 high blood glucose and put on diabetic meds. Mom attributes diabetes and hypertension to the drug. Threatened suicide several times.
NI

13yo F
Depression and Affective Disorder
Developed generalized edema, swollen tongue, on increased dose of 10 mg Abilify for depression. Also dysarthria. While taking Seroquel gained 10 lbs in 2 wks.
NI

13yo F
Depression and Bipolar Disorder
Began treatment 4/13/05 Patient experienced DM 2 in 7/06 and severe weight gain and acute metabolic syndrome.
Wellbutrin, Risperidal, Depakote

13yo F
Hosp
Bipolar Disorder, depression, anxiety
Began treatment 04 and diagnosed DM 2005, obesity with BMI 45.4. acute ER visits and hospitalization
NI

13yo M
Suicidal Depression, Bipolar Disorder
Developed insulin-dependent DM 2 yrs after treatment began age 13 1998 and DM diagnosis 2000. Developed DM and DKA 8/2000 Earliest treatment Seroquel noted 12/1999
lithium, paroxetine, valproate. amox, mirtazapine, escitablopram, citalopram, docusate, salbutamol, insulin, isophane, methylphenidate, heparin, fexofenadine, psuedoephedrine

13yo M
Mild to moderate anxiety; discontinued with generalized anxiety disorder. Impulsive, hostile, suicidal
Report alleged that Risperidone caused Patient to deteriorate psychiatrically 11/01-11/02 and also hospitalized for akathisia. Developed signs and symptoms of hyperprolactinemia which caused pt to have bilateral mastectomy; Patient had preadolescent gynecomastia. meds included sertaline and clonidine. High cholesterol 324; testosterone <20 ng/dl (normal range 241-827); Dr’s assessment preadolescent gyenecomastia. Dr noted no other meds that could relate to gyenecomastia except sertraline. Hospitalized ICU for diabetic ketoacidosis. Discharged with new onset diabetes.
risperidone, sertaline clonidine

13yo M
NI
HAND SURGERY, DIABETES His body mass index was 33.4.). Patient experienced diabetes which started during 2004 and hand surgery which started during 2007.
NI

13yo M
Hosp
Asperger's Syndrome
Experienced self-injurious behavior suicidal ideation, impulsive behavior, DM, high blood cholesterol triglyceride, vomiting, sleep disorder, food craving, high blood glucose. Pt hospitalized.
duloxetine, ziprasidone, diphnhydramine, paracetamol, phenylpropanolamine

13yo M
Anxiety and obsession symptoms
Treated with Seroquel for sleep aid 25 mg from 8/05-11/05. DM began 11/05. Other suspect drug was Abilify started 11/05 2.5-5 mg for agoraphobia but discontinued 11/05 due to hyperglycemic ketoacidosis; diabetic DKA glucose=660; blurred vision, urine frequency, etc. Medical history hepatitis B, sinusitis, sexually molested, adjustment disorder, phobia
fluoxetine for mood, anxiety, OCD, paroxetine for anxiety and agoraphobia

14yo F
ADHD, MR, Seizures, developmental delay, seizures on EEG, acid reflux, mood disorder, adjustment disorder, intermittent explosive disorder, oppositional disorder and increased blood glucose
Alleged report of diabetes as a result of Seroquel. Risperdal and Zyp0rexa. All 3 drugs from 3/04 to 6/04 for unspecified indication. 2004 experienced DM. med records 4/02-6/04 and pharmacy records 6/06. 13yo treated Weights: 3/02 128lb; 4/02 136lbs, 3wks later weight gain and discontinued Depakote and Zyprexa. 8/02 144lb 1/04 edema of hands and legs. Placed on Remeron for rest/mood in 2/04 and 7/05 glucose elevated. Seroquel started after olanzapine and valproate discontinued.
oxcarbazeoine clonidine venlafaxine, methylphenidate, valproate, fluoxetine, oxcarbazepine, paroxetine, ranitidine, clonazepam. Risperdal Zyprexa

14yo F
Depression
Patient developed diabetes and DKA. Diabetes onset was reportedly 1999 5yrs pre Seroquel but DKA 2005-6
NI

14yo F
Major depressive disorder, schizoaffective disorder, obesity, alcohol abuse, poly-substance abuse
Alleged report that female received risperidone on company suspect included olanzapine and Seroquel. No risperidone 2000-2007. Glucophage dispensed 12/00 and insulin dispensed beginning 9/04 Patient diagnosed with on insulin dependent DM. later had suicidal attempt, intentional overdose. Medical history Cushing’s syndrome
risperidone, olanzapine

14yo M
Bipolar Disorder, ADHD
Alleged DM after Seroquel. Had high cholesterol obesity, BMI 30.8 DM started 9/03 and chest pain 9/03
halopol, risperidone, chlorpromazine, olanzapine

14yo M
Schizophrenia
Patient experienced DM I starting in 2004. Med records reveal earliest date Seroquel 5/5/02. 14 yrs old at first event hospitalized 10/03 for psych disorders d/c 11/03 Dec 04 increased WBC 21.7 non-serious events, chest congestion, and hypertension. Following serious psych events schizophrenia, paranoid, impulse control disorder. Tourette syndrome, mild MR, pneumonia, obesity, asthma developmental delays, tonsillectomy, tubes in ears adenoidectomy. Psych history Schizophrenia, autism ADHD
methylphenidate, paroxetine, haloperidol, risperidone, phenobarbital, ziprasidone, Metformin, dipropylline, guaifenesin, hydrocortisone Geodon

16yo F
Hosp
NI
15 lb weight gain in 1 month after starting. Serious adverse event as Patient was hospitalized. Seroquel.
Klonopine (clonazepam)

16yo F
Mood instability, irritability
Treated with Seroquel for mood instability irritability and anger. Developed DM 10/02; BMI 304 weight gain and asthma ’05; obesity started in ’02. Med records 10/02 polyuria, polydypsia, PCO
ripseridone

16yo F
Schizophrenia
Borderline DM with 50 lb weight gain in past year after starting Seroquel.
risperidone lithium, topiramate, tranmolol, venlagaxine, hexacholesterolophene

16yo F
Bipolar Disorder
Blood Glucose increased up to 500 Patient taking Seroquel for past 6-8 months. Patient now on insulin. She had been on Zyprexa for a period of time and gained weight so was switched to Seroquel.
lamotrigine, sertraline. Zyprexa, Prozac

16yo F
NI
Increased triglyceride 500mg/ml. treated with Seroquel. After starting treatment unknown date had increased triglycerides starting 4/08. Seroquel was stopped and triglycerides dropped to 199.
lithium, aripiprazole.

16yo M
Hosp
ADHD; Bipolar Disorder anxiety
Hospitalized x 3 days fainted at school. Suicidal thoughts hypertension, suicidal ideation with intermittent depression.
modafinil; lamotrigine; escitalopram

17yo F
Depression PTSD
BMI=40.2 history of obesity. Seroquel 4/04 also 3/05; previous report stated start 3/04-1/05 weight gain 9/05 and 2/06 DM II; glucose intolerance 2/06 dysmetabolic syndrome 5/06 gastric bypass 8/06
risperidone

17yo F
Psychological problems
Seroquel began 2/02 dose not provided. DM insulin dependent began ~7/03 to ~10/04
buspirone, trazodone

17yo F
Bipolar Disorder
Seroquel since 2002 100mg for bipolar; experienced heart and DM problems in 2004. The patient's Body Mass Index was 30.9.
aripiprazole, clozapine and topiramate

17yo F
Hosp
Psychotic Disorder
Seroquel for psychoses and Seroquel XR. These were taken at various times outpatient and inpatient hospitalizations. Patient experienced increased weight, as well as lipid & metabolic profile.
lithium

17yo F
Hosp
Psychiatric history, psychosis NOS, depressed mood and schizoaffective disorder
Increase in schizophrenia and depression from 1/1999 to 12/06. Diabetes began 9/06. Medical records state: sickle cell trait & smoking. 11/05 had thoughts of death, depression, experienced hallucinations, agitation and was hospitalized. medical records reveal psych disorders, thryomegaly, menorrhagia, hallucinations.
aripiprazole, doxycycline, promethazine, metacclopromide, ethinlestradiol, norgestimate, medroxyprogesterone, prednisolone, hyoscyanine, acyclovir, famotidine, phenoxymethyl penicllin.

17yo M
Depression
Schizophrenia Bipolar disorder Diabetic Coma, DKA, Glycosuria, hyperglycemia, High triglyceride high cholesterol, Obesity, pancreatitis, neuroleptic malignant syndrome, tardive dyskinesia, BMI 39.6 developed diabetes 2 yrs
NI

17yo M
History schizophrenia, bipolar, depression, high cholesterol, high triglyceride, obesity, ETOH use
Developed gall stones and pancreatitis in 12/03. developed DM
Seroquel, Zyprexa risperidone

17yo M
Bipolar Disorder
Patient had a history of high triglycerides, obesity and alcohol use. The patient started quetiapine treatment on 10-Nov-2005. Experienced diabetic ketoacidosis, which started on 27-Oct-2002 and diabetes which started on 27-Oct-2002.
olanzapine aripiprazole and ziprasidone hydrochloride.

17yo F
NI
History included depression. Her body mass index was 21.6.The patient experienced diabetes and diabetic
ketoacidosis
insulin human, desonide, promethazine, insulin glargine, metoclopramide, Ortho tricyclen , metformin hydrochloride, Ortho EVRA patch Novolog mix Prenatal vitamin ferrous sulfate

17yo F
Sleep aid
Patient experienced diabetes and diabetic Ketoacidosis.
NI

When do we say enough is enough?





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