This medication was not recommended for children

Many medications are developed for children; many are developed for adults; MiraLAX (a product of Bayer Healthcare LLC) was NOT developed for children per its dosage instructions. Parents have reported serious neurological harm to children given MiraLAX. Please consider and speak with your child’s pediatrician before giving your child this product.

Dosage Instructions

A certain amount of information about who should and should not take MiraLAX is available on the bottle. A section of the label, identified as “Drug Facts” contains the following use and dosage instructions:

• Do not take more than directed unless advised by your doctor.
• Adults and children 17 years of age and older: fill to top of white section in cap which is marked to indicate the correct dose (17g); stir and dissolve in any 4 to 8 ounces of a beverage (cold, hot or room temperature) , then drink. Use once a day. Use no more than 7 days.
• Children 16 years of age or under: ask a doctor.

MiraLAX was originally approved by the Food and Drug Administration (FDA) as a prescription drug. It is now an over-the-counter medication readily available in many stores. Despite the fact that this drug was not developed for children, a number of doctors, including pediatricians, have prescribed or recommended this laxative for children for a number of years. (When a drug is prescribed or recommended contrary to information on the label it is called “off label” use.)

Harms to Children

Over a period of 15 years reports were submitted to the FDA about the harms to children who were given this medication. A study of the use of the drug in children was ordered, which is currently under way at Children’s Hospital of Philadelphia.

A reporter with WPVI-TV (an ABC affiliate) published in February of 2017 an article about this study. It includes several reports about harms done to children who were given this drug. A number of neuro-psychiatric effects of the drug in children were reported, including:

• Anger, rage, and aggression
• Paranoia
• Mood swings
• Phobias
• Fears and anxieties
• Manic behaviors

What to Do

Clearly the safest course of action for parents is to be wary of MiraLAX as a medication for children. If you are giving your child MiraLAX, you might want to consider stopping until more is known about the harm done to children given the medication, and certainly after speaking with your child’s pediatrician.

If your child has been harmed by taking MiraLAX, you should report the matter to the FDA Drug Safety Oversight Group.

If your child has been harmed, retain all documentation regarding administration of the drug and the emergence of harmful effects. You might also keep other notes relevant to the matter.

The attorneys of Altizer Law, P.C., have been representing Virginians who were hurt by medical malpractice or by ingesting a bad or an incorrectly prescribed drug for more than 20 years. We share the heartbreak of the parents. We represent the interests of those children with great determination and fight to obtain the maximum financial compensation decision or settlement possible under Virginia law. Call us. We’re here for you.