The Ocular Surface with Marguerite McDonald

Serious adverse events possible if children accidentally ingest OTC eye drops, nasal sprays

We tend to think of over-the-counter products such as eye drops and nasal sprays as safe, without any potential for harm. This is not the case; the FDA has warned the public that accidental ingestion by children of OTC redness-reducing eye drops and nasal decongestant sprays can result in serious harm.

The nasal sprays and eye drops that have been implicated in the cases of accidental ingestion contain the active ingredients tetrahydrozoline, oxymetazoline or naphazoline. These products are sold under various brand names, as store brands and as generics.

The cases of accidental ingestion reviewed by the FDA occurred in children 5 years of age and younger. Although no deaths were reported, serious events such as coma, decreased heart rate, decreased respirations and sedation have occurred.

Ingestion of only a small amount (1 mL to 2 mL; for reference, there are 5 mL in a teaspoon) of the nasal spray or eye drops can lead to serious adverse events in young children. Not all redness-reducing eye drops and nasal decongestant sprays come packaged with child-resistant closures, so children can easily access the contents if such bottles are within easy reach.

Between 1985 and October 2012, the FDA identified 96 cases of accidental ingestion of products containing tetrahydrozoline, oxymetazoline or naphazoline by young children. These cases were reported to the FDA’s Adverse Event Reporting System and the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance database. The children ranged in age from 1 month to 5 years. Fifty-three cases resulted in hospitalization due to symptoms including nausea, vomiting, lethargy, tachycardia, decreased respiration, bradycardia, hypotension, hypertension, sedation, somnolence, mydriasis, stupor, hypothermia, drooling and coma.

The cases reported that the children were either sucking or chewing on the bottles, or were found with an empty bottle next to them. In five cases, the children were found playing with the bottle; the case reports did not state if the children had ingested the drugs; however, they exhibited symptoms associated with the ingestion of the products. In four cases, the child gained access to the product by finding it in various places around his or her home.

Sixty-two cases reported the name of the product that had been ingested; these cases included various tetrahydrozoline, oxymetazoline and naphazoline products. Thirty-one of the 62 cases also reported an amount of the product that was ingested. The amounts ranged from 0.6 mL to one and one-half bottles (these products are packaged in 15-mL and 30-mL bottles). An article in the medical literature by Spiller and colleagues states that 2 mL to 5 mL of tetrahydrozoline 0.05% solution is capable of producing coma in a child. Additionally, two literature reports indicate that a 1.5 mL to 3 mL volume produced severe adverse events such as central nervous system and respiratory depression, and bradycardia in a 25-day-old infant and a 2-year-old child.

In 2012, the U.S. Consumer Product Safety Commission (CPSC) published a proposed rule requiring child-resistant packaging for redness-relief eye drops and nasal decongestant sprays. The proposed rule also covered products that contain xylometazoline, although such products are not currently marketed in the U.S. Having said that, American consumers are ordering significant numbers of products online, manufactured in other countries; it is difficult for the CPSC to monitor and control the packaging of these products.

A little history: At 57 years, the CPSC has the nation’s longest-running public health campaign, National Poison Prevention Week (NPPW). It is always the third week of March, as proclaimed by President John F. Kennedy in 1962; this year, it took place from March 17 to 23. As a longtime supporter of NPPW, one of the CPSC’s greatest contributions to the effort has been the requirement of child-resistant closures on certain medicines and household chemicals.

When NPPW was launched 57 years ago, about 400 children died each year from unintentional poisoning. The most common culprit was aspirin. Today, about 40 children die each year of unintentional poisoning. Although this represents significant progress, CPSC believes that it is still too many, which is why the agency continues to identify and address new and recurring poison dangers.

The agency encourages consumers to take the following safety steps to prevent unintentional poisonings:

  1. Keep medicines and household chemicals in their original child-resistant containers.
  2. Store potentially hazardous substances up and out of a child’s sight and reach.
  3. Keep the national Poison Help Line number, 800-222-1222, handy in case of a poison emergency.
  4. When hazardous products are in use, never let young children out of your sight, even if it means you must take them along when answering the phone or doorbell.
  5. Leave the original labels on all products, and read the labels before using the products.
  6. Always leave the light on when giving or taking medicine so you can see that you are administering the proper medicine, and be sure to check the dosage every time.
  7. Avoid taking medicine in front of children. Refer to medicine as “medicine,” not “candy.”
  8. Clean out the medicine cabinet periodically and safely dispose of unneeded and outdated medicines.
  9. Do not put decorative lamps and candles that contain lamp oil where children can reach them. Lamp oil can be toxic if ingested by children.

Consumers should store these products out of reach of children at all times. If a child accidentally swallows eye drops or nasal decongestant spray, or another medicine or toxic material, call the toll-free Poison Help Line and seek emergency medical care immediately.

Disclosure: McDonald reports no relevant financial disclosures.

We tend to think of over-the-counter products such as eye drops and nasal sprays as safe, without any potential for harm. This is not the case; the FDA has warned the public that accidental ingestion by children of OTC redness-reducing eye drops and nasal decongestant sprays can result in serious harm.

The nasal sprays and eye drops that have been implicated in the cases of accidental ingestion contain the active ingredients tetrahydrozoline, oxymetazoline or naphazoline. These products are sold under various brand names, as store brands and as generics.

The cases of accidental ingestion reviewed by the FDA occurred in children 5 years of age and younger. Although no deaths were reported, serious events such as coma, decreased heart rate, decreased respirations and sedation have occurred.

Ingestion of only a small amount (1 mL to 2 mL; for reference, there are 5 mL in a teaspoon) of the nasal spray or eye drops can lead to serious adverse events in young children. Not all redness-reducing eye drops and nasal decongestant sprays come packaged with child-resistant closures, so children can easily access the contents if such bottles are within easy reach.

Between 1985 and October 2012, the FDA identified 96 cases of accidental ingestion of products containing tetrahydrozoline, oxymetazoline or naphazoline by young children. These cases were reported to the FDA’s Adverse Event Reporting System and the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance database. The children ranged in age from 1 month to 5 years. Fifty-three cases resulted in hospitalization due to symptoms including nausea, vomiting, lethargy, tachycardia, decreased respiration, bradycardia, hypotension, hypertension, sedation, somnolence, mydriasis, stupor, hypothermia, drooling and coma.

The cases reported that the children were either sucking or chewing on the bottles, or were found with an empty bottle next to them. In five cases, the children were found playing with the bottle; the case reports did not state if the children had ingested the drugs; however, they exhibited symptoms associated with the ingestion of the products. In four cases, the child gained access to the product by finding it in various places around his or her home.

Sixty-two cases reported the name of the product that had been ingested; these cases included various tetrahydrozoline, oxymetazoline and naphazoline products. Thirty-one of the 62 cases also reported an amount of the product that was ingested. The amounts ranged from 0.6 mL to one and one-half bottles (these products are packaged in 15-mL and 30-mL bottles). An article in the medical literature by Spiller and colleagues states that 2 mL to 5 mL of tetrahydrozoline 0.05% solution is capable of producing coma in a child. Additionally, two literature reports indicate that a 1.5 mL to 3 mL volume produced severe adverse events such as central nervous system and respiratory depression, and bradycardia in a 25-day-old infant and a 2-year-old child.

In 2012, the U.S. Consumer Product Safety Commission (CPSC) published a proposed rule requiring child-resistant packaging for redness-relief eye drops and nasal decongestant sprays. The proposed rule also covered products that contain xylometazoline, although such products are not currently marketed in the U.S. Having said that, American consumers are ordering significant numbers of products online, manufactured in other countries; it is difficult for the CPSC to monitor and control the packaging of these products.

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A little history: At 57 years, the CPSC has the nation’s longest-running public health campaign, National Poison Prevention Week (NPPW). It is always the third week of March, as proclaimed by President John F. Kennedy in 1962; this year, it took place from March 17 to 23. As a longtime supporter of NPPW, one of the CPSC’s greatest contributions to the effort has been the requirement of child-resistant closures on certain medicines and household chemicals.

When NPPW was launched 57 years ago, about 400 children died each year from unintentional poisoning. The most common culprit was aspirin. Today, about 40 children die each year of unintentional poisoning. Although this represents significant progress, CPSC believes that it is still too many, which is why the agency continues to identify and address new and recurring poison dangers.

The agency encourages consumers to take the following safety steps to prevent unintentional poisonings:

  1. Keep medicines and household chemicals in their original child-resistant containers.
  2. Store potentially hazardous substances up and out of a child’s sight and reach.
  3. Keep the national Poison Help Line number, 800-222-1222, handy in case of a poison emergency.
  4. When hazardous products are in use, never let young children out of your sight, even if it means you must take them along when answering the phone or doorbell.
  5. Leave the original labels on all products, and read the labels before using the products.
  6. Always leave the light on when giving or taking medicine so you can see that you are administering the proper medicine, and be sure to check the dosage every time.
  7. Avoid taking medicine in front of children. Refer to medicine as “medicine,” not “candy.”
  8. Clean out the medicine cabinet periodically and safely dispose of unneeded and outdated medicines.
  9. Do not put decorative lamps and candles that contain lamp oil where children can reach them. Lamp oil can be toxic if ingested by children.

Consumers should store these products out of reach of children at all times. If a child accidentally swallows eye drops or nasal decongestant spray, or another medicine or toxic material, call the toll-free Poison Help Line and seek emergency medical care immediately.

Disclosure: McDonald reports no relevant financial disclosures.