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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

  1. Gravatar for rose

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

  2. Gravatar for Concerned Nurse
    Concerned Nurse

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

  3. Gravatar for Anne

    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

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