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Michael Monheit
Michael Monheit
Attorney • (215) 840-6573

Dangers with Unproven Laxative Used for Children

3 comments

An article in the New York Times last year highlighted the widespread use of polyethylene glycol 3350 (sold as brand name MIRALAX), an over-the-counter laxative, in children to help constipation, although it was never approved for pediatric use.

The drug, first approved by the FDA in 1999, has become a staple in American homes to assist bothersome and often distressing bouts of childhood constipation. The concern, however, is that PEG-3350 has not yet been studied in children for periods longer than a year and concerns have been surfacing that question the drug’s long-term safety.

Pediatricians are mainly concerned because the symptom, and not the underlying cause, is treated when prescribing Miralax in young children.

Merck said, in a statement, that it recommends the use of Miralax in patients 17 and older and for only a week. They further said, “It regularly analyzes and reports all adverse event information as part of an ongoing post-marketing surveillance.” When asked if the company is intending to conduct studies to get FDA approval for pediatric use, the company declined to say.

Common Side Effects of Laxatives

If used correctly, most laxatives don’t have side effects. However, they can cause diarrhea, cramping, bloating and gas.

Some people, children included, are at risk for electrolyte imbalances when taking certain laxatives. Electrolytes help your nerves, organs and muscles to properly work. Taking laxatives can cause the elimination of too many electrolytes which can lead to other health concerns including headaches, vomiting, spasms and more. An electrolyte imbalance can be serious so it is imperative to speak to your pediatrician before use.

3 Comments

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  1. rose says:
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    They are very dangerous! My daughter had very scary neurological changes. Why on earth are they even suggested?

  2. Concerned Nurse says:
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    This drug is POISON with DEATHS and over 5,000 reports of adverse reactions submitted to the FDA.

  3. Anne says:
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    MIRALAX SIDE EFFECTS         Call 1-800-FDA-1088

    reported to the FDA by parents of children who were given Miralax

    (limited list-more side effects reported since compiled)

    Anxiety
    Phobias
    Extreme nervousness
    Obsessive-Compulsive behavior
    Scratching, biting (self and others)
    Nightmares
    Hysteria
    Memory loss
    Sleeplessness
    Irritability
    Mood swings
    Bipolar disorder
    Withdrawal
    Communication loss
    Loss of concentration
    Vertigo while lying down
    Anger
    Tantrums
    Metabolic acidosis
    Clawing sister’s eyes
    Sensitivity to sound
    Motor skills affected
    Fearfulness
    Confusion
    Inability to focus
    Mumbled speech
    Gait disturbances
    Obsessive finger licking
    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
    Tics
    Tremors

    Seizures:
    life threatening with 3 fatal cases documented and more suspected

    Violent behavior
    Suicidal thoughts (age 6)
    Paranoia/bizarre hiding
    Anti-social behavior
    Slurred speech, whispering
    Staring
    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

    This is a short list, there are many others have symptoms that have been reported.

    Call 1-800-FDA-1088