FDA adverse reports READ IT and WEEP...Pages19&20

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B. Statement of Grounds, Continued Adverse Events, ContinuedNeuropsychiatric Symptoms Parents have reported a myriad of neurological symptoms experienced by their children while on polyethylene glycol products, some residual and some permanent. A visit to the Miralax Yahoo Group http://health.groups.yahoo.com/group/miralax/ provides insight into the heart wrenching stories of parents in despair over the changes in their children while on these products. Children and families are suffering the extreme stress associated with the ‘loss’ of the children they once knew. ​​​Anxiety​Mumbled speech​Phobias​Gait disturbance​Extreme nervousness​ Obsessive finger licking​Obsessive-Compulsive behavior​Feelings of something dripping down face​Scratching, biting (self and others)​Compulsive bad thoughts​Nightmares​‘Meltdowns’ over homework​Hysteria​‘Meltdowns’ over trivial things​Memory loss​‘Panic’ behavior​Sleeplessness​‘Dr. Jeckyll & Mr. Hyde’ behaviors​Irritability​‘Wave pool feeling’ when trying to go to sleep​Mood swings​Tics​Bipolar disorder​Tremors​Withdrawal​Seizures​Communication loss​Violent behavior​Loss of concentration​Suicidal thoughts (age 6)​Vertigo while lying down​Aggression​Anger​Depression​Tantrums​Suspected encephalopathy​Metabolic acidosis​‘Wild behavior’​Clawing sister’s eyes​Death threats (age 7)​Sensitivity to sound​​Paranoia / bizarre hiding​​Motor skills affected​​Anti-social behaviorFearfulness​Slurred speech, whisperingConfusion​Staring Inability to focus * Death *The attached FDA Adverse Event Reporting System reportsinclude deaths in children while being administered polyethylene glycol products. Suicide and attempted suicide are also reported in the FDA Adverse Events Reporting System.http://xa.yimg.com/kq/groups/12842967/1400876968/name/children.pdfB. Statement of Grounds, ContinuedAdverse Events, ContinuedOther Events Reported with Polyethylene Glycol UseIncreased anion gap – excessive acids in the bloodBlood amylase increases - pancreas, liver function Blood urea increased, urinary failureLipase increased - pancreas not working well Urinary retentionIntestinal perforation Cardiac failurePetechiae - red dots on skin Dysphonia - hoarseness in voiceDyspnea - shortness of breathPharyngolaryngeal painTongue odema - swellingBrain odema - swellingNeuropathy, retching Chills Eosinophil count - allergic reaction Pruritus, itchy skin disorderNervous system disorderSudden deathBlood albumin decreased - not enough protein in blood Renal tubular necrosis, renal failureBlood Potassium decreasedHypocalcemiaBlood sodium abnormal ConvulsionsComaGait disturbanceUrticaria - hivesShockErythema – skin reactionBlood Pressure decreasedHypercalcemia - high potassiumBlood electrolyte abnormal​Blood potassium decreased Abdominal distention Flushing Peritonitis - lining of bowel inflamed Enuresis - night wetting Anaphylactoid reaction – immune responseMouth ulceration Tetnay, rigors – muscle contractionsSudden deathPeeling of skin NauseaGasExtreme bloatingAbdominal painB. Statement of Grounds, ContinuedAdverse Events, ContinuedEncropresis, involuntary fecal soiling (due to loss of muscle control)Ileus - paralysis of bowelsBowel ecology imbalance, loss of probioticsRashesEczema More ReportsDruglib.com reports 95 adverse events among Miralax users between April 2009 and March 2010.http://www.druglib.com/adverse-reactions_side-effects/miralax/ Clinical TrialsResults BuriedPharmaceutical industry funded clinical trials are on trial themselves. A study published in the ls of Internal Medicine found that drug companies are not reporting results of all clinical trials and, in fact, are reporting positive outcomes in 85 percent of publications versus 50 percent for government funded studies.