8 Medications Not Approved for Children

When your child is feeling unwell, your first instinct is to head to the drug store and bring them medicine to make them feel better. However, all medicines the Food and Drug Administration (FDA) approved for adults are not necessarily safe for children. It’s important to remember that children are not simply small adults. Whether a medication is safe and effective in children depends on several factors such as the child’s age and development, body weight, dosage, and drug side effects, which can be significantly different in children than adults.

Please continue reading to learn more about some medications that are not approved for children or should be used with caution.

What is the FDA approval process?

Before looking at some medications that may not be safe for children, let’s take a look at the FDA approval process. The Food and Drug Administration (FDA) is responsible for approving medications and ensuring medication safety and efficacy in the United States. When drug companies develop a new drug, they are required to do a series of clinical trials to make sure the medicine is safe and effective before it becomes available to the public. Based on the results of these clinical trials, the Food and Drug Administration (FDA) approves the medication for use in specific groups of patients for specific symptoms or health conditions.

Once drugs companies have received FDA approval, doctors may prescribe the medicine for something other than what it was approved for when they judge that it is medically appropriate for their patient. This is often called “off-label” use, meaning the medicine is used for something other than what is described on FDA labeling and FDA approval.

Prescribing medication off-label is quite common. For example, if a doctor determines that a medication is safe and effective for your child based on scientific evidence and medical expertise, they may prescribe it off-label even though it is not FDA- approved for children and does not have pediatric labeling. This is because it is an expensive process for drug companies to get FDA approval and can take up to 12 to 16 years. Also, pediatric drug development can be particularly challenging because it requires clinical trials in children. However, the FDA uses the Pediatric Research Equity Act to provide incentives to drug companies by adding six months of marketing exclusivity to drugs tested in pediatric populations.

Why is it important to know potentially inappropriate medications in children?

Simply assuming that children are small adults and adjusting the dose according to body weight can be dangerous. For example, in the 1950s, the antibiotic chloramphenicol was used to treat penicillin-resistant bacterial infections. However, when newborns or premature babies were given chloramphenicol, their livers were not mature enough to break down the drug, putting them at high risk of gray baby syndrome that can result in death.

Therefore, doctors don’t just prescribe lower doses of FDA-approved medications for adults to pediatric patients. Instead, they rely on research published in pediatric pharmacology journals that demonstrate how a medicine works in children and what adverse drug reactions can occur. They make decisions based on these scientific findings.

What medications are contraindicated in children?

1. Aspirin

Not recommended for: Children younger than 18 years old.

Aspirin has been linked to Reye’s Syndrome in children. This is a rare but serious condition in which there is swelling in the brain and liver. It most often affects children recovering from a viral infection such as the flu or chickenpox. Therefore, although aspirin is approved for use in children over the age of 3, it should be used only in rare cases with extreme caution and under close monitoring by a doctor. If your child needs something for pain relief, acetaminophen (Tylenol) is a safer option.

2. Ibuprofen

Not recommended for: Babies younger than 6 months old.

There are ibuprofen products (Advil, Motrin) for infants available on the market. However, doctors recommend acetaminophen (Tylenol) for babies under 6 months of age to treat ailments like fever and teething pain because ibuprofen can lead to kidney problems. Pediatric pharmacists and doctors recommend using acetaminophen because it is safer and less likely to cause adverse drug reactions.

3. Prescription Codeine Cough Medicines

Not recommended for: Children younger than 12 years old.

Codeine is FDA approved to treat cough and pain. However, medicines that contain codeine as the only ingredient should not be used in children under 12 years old because they can cause slowed or difficult breathing and death.

4. Diphenhydramine

Not recommended for: Children younger than 2 years old.

Diphenhydramine (Benadryl) is an antihistamine used to treat symptoms of allergies, hay fever, and the common cold. It is a first-generation antihistamine and may be a potentially inappropriate medication in children. Diphenhydramine is not a cure; it simply provides allergy symptom relief. And while this medicine has sedating effects, it should never be used to help children sleep.

5. Loperamide

Not recommended for: Children younger than 3 years old.

Loperamide (Imodium) is a medication prescribed to treat diarrhea. It is also available in some over-the-counter antidiarrheal products. However, pediatric studies have shown that in children younger than 3 years old, the risk of adverse events outweighs the benefits, even at low doses.

6. Xylometazoline Nasal Drops

Not recommended for: Babies and young children.

Xylometazoline (Otrivin) nasal drops are FDA approved for use in infants, children, and adults. However, doctors advise against using this medication, especially in babies less than 2 weeks old, because it can cause drying of the nasal passages. Using a cool-mist humidifier and aspirator (snot sucker) is the safest way to relieve a stuffy nose in young children.

7. Benzocaine Teething Gels

Not recommended for: Children younger than 2 years old.

Benzocaine is a local anesthetic. Teething gels containing benzocaine (Baby Orajel, Anbesol, Chloraseptic, Cepacol, Hurricaine, Orabase, and Topex) are available over the counter on the market. However, the FDA warns against the potentially inappropriate medication use of these topical agents to treat teething pain in children (age group less than 2 years). These products offer little to no benefit and can be dangerous. They are not useful because they get washed away within minutes. Benzocaine gels, ointments, sprays, solutions, and lozenges for mouth and gum pain have been linked to a potentially fatal condition called methemoglobinemia, in which the red blood cells lose their ability to carry oxygen.

8. Senna glycosides

Not recommended for: Children younger than 2 years old.

Senna glycosides (Senokot, Ex-Lax) are used to treat constipation and are available over the counter. However, doctors do not recommend using these medications in children because safer alternatives are available. In babies and children, laxatives that contain lactulose or PEG 3350 (Lax-A-Day or MiraLax) can be safely used for 3-4 weeks while adjusting the child’s diet to include more fiber. If your baby is younger than 6 months old and is constipated, please consult their pediatrician to make sure there is nothing more serious going on.

This list of off-label drugs and children’s medications is a guideline to help you in determining inappropriate medication for your child. However, to ensure medication safety, it is best to obtain medical advice from your child’s doctor before giving your child any over-the-counter or prescription drugs.

The Takeaway

The FDA ensures drug safety and efficacy in the United States. Sometimes, medications approved for use only in adults might be prescribed to kids. This does not mean your child’s doctor is irresponsible. Prescription drugs are frequently prescribed “off-label” after there is sufficient evidence that they are safe and effective in children. This happens because a drug company may not want to go through the costly and lengthy process of getting more than one FDA approval.

If your child’s doctor is prescribing medication off-label (giving your child drugs approved for adults), ask them how long the medication has been on the market and what’s their experience with prescribing it to children. You should also ask about the side effects of an off-label medication in the pediatric population.

Lastly, it is important that you do not give your child an unapproved medication (one that does not have FDA approval at all). This means the drug has not been tested for safety and efficacy and could be dangerous.

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