Cold Medicine Warning for Toddlers: The Risks of Pseudoephedrine to Young Children

If you�re a mother of a toddler, taking care of your toddler�s health is a key priority. Toddlers can become prone to a variety of infections, such as ear infections and Croup cough. But sometimes the very treatments designed to help improve childrens health, such as cough syrup, can lead to serious health problems. In fact, over 1500 toddlers and infants were sent to the emergency room over the past two years because of a negative reaction to cough medicine containing the decongestant pseudoephedrine, three of whom died due to fever. Why did these children have such reactions to the cough remedy? What are some common pseudoephedrine side effects and is there a safe dosage of cough medicine containing pseudoephedrine for your child?

What is Pseudoephedrine?

Pseudoephedrine is a decongestant found in many common cough remedies and cold syrups. It is used in a variety of cough syrups for both children and adults to relieve nasal and sinus congestion caused by common colds, sinus problems, hay fever and other allergies, as well as to treat ear inflammations and ear infections.

It works by shrinking the blood vessels in the nose, lungs and other mucus membranes found in the body by restricting blood flow to these areas.

In addition, pseudoephedrine is only available by prescription, in capsule, syrup, tablet and oral solution form.

What is a Safe Pseudoephedrine Dosage for Children?

Generally, a regular (short accounting) oral dosage of pseudoephedrine in the form of capsules, syrup, tablets, and oral solution is safe for young children, including infants and toddlers. However, a doctor should determine the exact dosage for infants and toddlers up to the age of two.

Alternatively, long-acting oral dosages of pseudoephedrine, such as extended-release tablets or extended-release capsules, are not recommended for children up to the age of 12.

The U.S. Centers for Disease Control and Prevention recommends that parents not administer over-the-counter cough remedies to children under the age of 2 without first consulting a doctor.

This recommendation was based on a 2005 investigation of the deaths of 3 infants who were 6 months old and younger, who died of a fever after consuming cough syrup containing pseudoephedrine. The investigation found that the infants had levels of the decongestant that was up to 14 times the recommended pseudoephedrine dosage for children between 2 and 12 years of age.

However, it is unknown how much cold medicine the children who died had consumed.

Currently, there is no specific pseudoephedrine laws approved by the Food and Drug Administration that regulate an approved dosage of cough remedies containing pseudoephedrine

It is important to remember to keep cough medicines out of the reach of children at all times.

Pseudoephedrine Overdose

The following are symptoms of a pseudoephedrine overdose:

  • trouble breathing and/or shortness of breath
  • irregular heartbeat
  • unusual restlessness, excitement or nervousness
  • increased blood pressure
  • convulsions
  • hallucinations

Other side effects of abuse of pseudoephedrine can include:

  • trouble sleeping
  • head ache
  • nausea or vomiting
  • paleness
  • weakness

Pseudoephedrine and Breastfeeding Mothers

In addition to affecting a child�s health, the decongestant can have a negative impact on the health of moms.

Because pseudoephedrine passes through breast milk, it is advised that breastfeeding moms do not take cough remedies containing pseudoephedrine, as it can lead to negative side effects in infants, particularly in newborns and premature infants.

Pseudoephedrine and Pregnancy

There have not been any studies conducted on the effects of pseudoephedrine on human fetuses.

However, animal studies have not shown any link between the decongestant and birth defects. Nevertheless, animal studies did show that the use of the decongestant led to a decreased average birth weight or length, as well as decreased bone formation in the animal fetuses.

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