Anne Williams RN BSN


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    Anne Williams RN BSN
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    Apr 24 '16

    January 2015: brief article about Miralax written by a lawyer:

    Facebook site October 2015
    "Parents against Miralax" with almost 2000 members.
    Many parents would like a letter of intent to sue submitted to expose issues with Miralax.

    Miralax@yahoogroups on-line with over 2000 members.

    Almost 14,000 adverse events reported to the FDA as of March 2016.

    In 2009 the FDA held an oversight board meeting in response to increasing complaints.
    The FDA took NO ACTION, but several concerns were highlighted:

    “In 2009 the Drug Safety Oversight Board discussed reports of metabolic acidosis, metabolic acidosis with increased anion gap, and neuropsychiatric adverse events in children using polyethylene glycol (PEG) products. Metabolic acidosis is a disturbance in the body’s acid base balance and causes too much acid in the blood. In some situations, metabolic acidosis can be a mild, chronic condition; however, it may lead to shock or death in severe cases. Neuropsychiatric adverse events may include seizures, tremors, tics, headache, anxiety, lethargy, sedation, aggression, rages, obsessive-compulsive behaviors including repetitive chewing and sucking, paranoia and mood swings.”

    In 2011 the FDA warned against "POSSIBLE NEUROPSYCHIATRIC EVENTS" from Miralax.

    Two New York Times articles have spotlighted Miralax and concerning issues with side effects:

    Interview with Carol Chittenden with the EMPIRE STATE CONSUMER PROJECT discussing overwhelming reports against Miralax with minimal action being taken by the FDA.
    50,500+ views on-line.

    After two years a $325,000.00 grant from NIH in collaboration with the FDA awarded to study to investigate possible absorption issues. Several institutions applied for grant, but Children’s Hospital of Philadelphia, a few miles from Merck was awarded the grant. Considering 40-50% of FDA funds come from the pharmaceutical industry this raises ethical questions.

    In 2008 the FDA detected the two poisons di-ethylene glycol and ethylene glycol in all eight lots of Miralax tested, yet this was not disclosed to the public. Ethylene glycol poisoning and polyethylene glycol poisoning present with almost identical symptoms. This information was disclosed in grant award information released by the FDA.

    Per article below: “Those tests were conducted in 2008, but the results were not disclosed. Jeff Ventura, an FDA spokesman, said batches were tested because “many of the reported adverse events were classic symptoms of ethylene glycol ingestion.”

    Apr 24 '16
    April 24, 2016 News FDA reports are now at 14,974!
    Apr 24 '16
    by parents of children who were given Miralax
    over 13,000 reports to FDA as of January 2016

    FDA petition link:

    (limited list-more side effects reported since compiled)

    Phobias, fear
    Extreme nervousness
    Obsessive-Compulsive behavior
    Scratching, biting (self and others)
    Memory loss
    Mood swings
    Bipolar disorder
    Communication loss
    Loss of concentration
    Vertigo while lying down
    Anger, often unexplainable
    Metabolic acidosis
    Clawing sister's eyes
    Sensitivity to sound
    Motor skills affected
    Inability to focus
    Mumbled speech
    Gait disturbances
    Constant throat clearing
    Obsessive finger licking
    Sucking on fingers
    Sucking on objects
    Obsessive chewing on objects
    Feelings of something dripping down face
    Compulsive bad thoughts
    'Meltdowns' over homework
    'Meltdowns' over trivial things
    'Panic' behavior
    'Dr. Jekyll & Mr. Hyde behaviors
    'Wave pool feeling' when trying to go sleep
    Hepatic enzyme increased
    Incorrect drug administration
    Memory impairment
    Middle insomnia
    Nervous system disorder
    Personality change
    Thumb sucking
    Swollen tongue
    Oral pain
    hair loss
    low iron and zinc levels
    Lipodystrophy acquired
    Weight increased
    Balance disorder
    Incorrect drug administration duration
    Oropharyngeal pain
    Off label use
    Vocal chord disorder
    Robot like speech
    Autism, Autistic Spectrum Disorder
    Akathisia unexplained restlessness
    Burning of skin externally with persistent redness
    (looked like scalding from hot water)
    Stunted growth, delayed weight gain several months to a year after Miralax/PEG stopped

    Scoring below age level on test after Miralax started, before all test within normal range
    After Miralax daughter no longer met expected developmental milestones
    Scratching others
    Difficulty falling asleep every night (4-5 hours to fall asleep)
    Wakeful during night
    "falling to pieces" within first four days on Miralax
    Unrelieved constipation
    Worsening behavior as days of Miralax progressed
    Irritable fussy
    Frequent hysterical crying
    Unable to appease, no matter what
    Unable to calm down once upset
    Unable to listen
    Frequent unexplainable loss of temper
    "possessed by the devil"
    Refused to get dressed
    Would fight constantly with mother
    Constantly pulling clothes off once mother got them on
    Constantly wanting to be naked, appeared miserable, 'wanted to get out of her skin'
    Atypical behavior
    Frequent kicking and screaming
    Frequent 'acting up'
    Communication loss. With robotic like talking (mother states this has not resolved years later and daughter will talk like this 1-2 X week)

    Emesis would 'bleach' stains on the carpeting months after Miralax given
    Throat burn
    Esophageal irritation

    Brain swelling confirmed by lab work and pediatric neurologist and treated with Prednisone

    Any doctor suggesting Miralax is safe is uninformed!

    Off label prescribing can be reported to your state medical board. The only way we can get doctors to stop recommending this to children is to hold them accountable.

    life threatening with a minimum of 3 fatal cases documented and several more suspected

    Violent behavior
    Suicidal thoughts (age 6)
    Paranoia/bizarre hiding
    Anti-social behavior
    Slurred speech, whispering
    Skin disorders
    Keratosis pilaris - chicken skin, what appears to be Miralax particles trying to exit the body through the skin, primarily on the arms and legs

    Homicidal ideation

    Homicide (14 year old boy shot and killed his father, stating he did not know why. He reported feeling like he was in a shell and was paranoid. The prepubescent brain in a male is the same size it will be at age 25, however the skull is much smaller. Brain swelling can cause Central Nervous System Irritability. A hyponatremia (low sodium) can cause a metabolic acidosis. In other words Polyethylene glycol, like all other drugs can cause a "substance induced toxic psychosis".

    Reports of porous teeth
    Accelerated tooth decay

    Is this effecting bone marrow production and bone development?

    Polyethylene glycol is used as a humectant to moisten dog food.
    Many dogs suffer from seizures and must be medicated, often diagnosed with epilepsy...?

    There are other symptoms that have been reported to the FDA...

    Please Call 1-800-FDA-1088 if you have not filed a report.

    For busy mothers you can insist on completing a report of an adverse reaction over the phone and request a copy.

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