National Medical Products Administration: This Drug is Forbidden for Children! How Dangerous Is It?  

National Medical Products Administration: This Drug is Forbidden for Children! How Dangerous Is It?  

Source: Sunflower Children  

Author: Guo Yanru  

Editor: Gao ZX  

Date: August 3, 2023  

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This Cold Medicine is on the "Blacklist"

On September 6, 2018, the National Medical Products Administration issued a notice requiring revisions to the instructions for cold medicines containing codeine. The notice stated that medications containing codeine must clearly indicate in the "Contraindications" or "Pediatric Use" sections that they are prohibited for individuals under 18 years of age.

Moreover, authoritative organizations such as the World Health Organization and the U.S. Food and Drug Administration have also issued warnings regarding the use of codeine by children, banning its use in pediatric medicine.

Why Does Codeine Keep Making the "Blacklist"?

What Is Codeine?

Codeine phosphate, also known as methyl morphine, is a central nervous system opioid analgesic that can lead to addiction. It is used for severe, frequent dry coughs and moderate to severe pain.

Repeated administration of codeine can lead to tolerance, and long-term use can result in addiction. As children are a vulnerable population, the use of such drugs is strictly prohibited. Parents should only administer medication under the guidance of a specialist and avoid purchasing codeine-containing drugs without a prescription.

According to the National Medical Products Administration website, there are several medications that contain codeine. It is crucial for everyone to be vigilant when purchasing and using these medications.

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"Invisible Drug," Potentially Life-Threatening

So why can’t children use codeine? Firstly, medications containing codeine have addictive properties. Improper use can result in hallucinations and can damage children's liver and kidneys. Additionally, incorrect usage can lead to respiratory depression, which can be severe and even fatal. In a sense, codeine has become an "invisible drug." This is why the National Medical Products Administration has explicitly banned the use of such medications for children and adolescents under 18 years of age due to safety concerns.

Furthermore, administering codeine to children may lead to morphine toxicity!

After codeine is absorbed in the body, about 10% is metabolized into morphine by a liver enzyme called CYP2D6. In most of the population in our country, only a small amount of codeine is converted to morphine after taking the recommended dosage. However, there are certain individuals (approximately 0.9% to 1.3%) who express high levels of the CYP2D6 enzyme, and even taking the recommended safe dose can lead to a significant metabolism into morphine, causing rapid accumulation in the body and potentially leading to morphine toxicity.

Clinical Use Precautions

According to the revised instructions for medications containing codeine (see end of article), when administering such medications to children with late-stage cancer, the following points must be noted:

- Children under 12 years old are prohibited from using these medications, and those known to be ultra-rapid metabolizers of CYP2D6 should also not use them (this can be determined through genetic testing).

- Children and adolescents aged 12 to 18 with chronic respiratory diseases are not recommended to use codeine.

- For patients aged 12 to 18, codeine should only be used temporarily for the acute treatment of moderate cancer pain when morphine-type analgesics cannot be obtained, and only when pain cannot be alleviated by other non-steroidal anti-inflammatory drugs.

What Medications Are on the "Whitelist"?

For children experiencing cancer-related pain, the recommended approach is the stepwise analgesic ladder. For short-term mild to moderate pain, acetaminophen and ibuprofen are generally the first choices, while strong opioids are recommended for persistent moderate to severe pain. Codeine is classified as a weak opioid and is not recommended for long-term use in children.

Both codeine and tramadol are effective for moderate pain, but due to the progression of late-stage hematologic cancers, pain can intensify. These weak opioids share similarities with non-steroidal medications, and the potential risks associated with long-term use have not been adequately recognized by healthcare professionals, leading to significant misuse among children. In fact, both medications are especially not recommended for children.

Recent guidelines recommend the use of low-dose strong opioids (such as morphine or oxycodone) for managing cancer pain, defining low doses of oxycodone (≤20mg/24 hours), morphine (≤30mg/24 hours), and hydromorphone (≤4mg/24 hours) as equivalent to second-step opioids. This approach offers effective analgesic results and convenient dose conversions. In other words, if non-steroidal medications do not provide sufficient relief, healthcare professionals may consider the direct use of morphine-type medications under their guidance.

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Book Introduction: 

As human life expectancy increases, the issues surrounding pain have also become more prevalent. To help people better understand pain, several experts have compiled their years of clinical experience into an accessible guide that systematically covers the basics of pain understanding, diagnosis, treatment, and care, making it suitable for patients in pain or their families to read.

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Column Author: Guo Yanru  

Deputy Chief Physician, Palliative Care Department, Cangzhou People's Hospital, Hebei Province  

Editor: Zuo Jia, Xia Yu  

Typesetting: Xia Yu  

Proofreading: Xiu Xiu