The secret to a popular cold medicine. Request for suspension of sales by U.S. FDA

▲ Theraflu

ⓒ Hailion Korea

As the weather suddenly got colder, the number of people looking for cold medicine at pharmacies increased significantly. Among them, many people are looking for Theraflu, a cold medicine that is taken in the form of tea and dissolved in warm water. However, Theraflu has been experiencing severe out-of-stock problems for the past two years. Popular cold medicine suddenly became difficult to obtain at pharmacies. Why?

On November 7, the U.S. Food and Drug Administration (FDA) officially announced that the nasal medication phenylephrine was ineffective and sent an official letter requesting that companies selling phenylephrine stop selling it. The effectiveness of phenylephrine has been a subject of debate for a long time. Although researchers and civic groups have called for the withdrawal of the ineffective drug phenylephrine, cold medicine companies that use phenylephrine, such as Theraflu, have been pushing for the withdrawal of phenylephrine for nearly 20 years for reasons such as patients’ right to access the drug.

Last September, an FDA advisory committee unanimously concluded that phenylephrine was ineffective. The government withdrew the widely used nasal medication that was approved as an over-the-counter drug in 1976. However, it took a year and two months from the advisory committee decision to the FDA decision. In addition, the action was not immediate expulsion, but a proposal to stop sales. Considering that phenylephrine is not only ineffective for nasal colds but also causes side effects if used incorrectly, immediate withdrawal would have been appropriate. This is for patients who take ineffective medications and experience problems such as dizziness or increased blood pressure.

The fact that Theraflu has been out of stock since last year was not actually a problem caused by a sudden increase in the number of people trying to purchase it. This is an intentional supply shortage that occurred because the company reduced production to manage inventory for fear of being kicked out of the United States.

PPA, a nose cold medicine, causes cerebral hemorrhage

This is not the first time that commonly used nasal medication such as phenylephrine has been problematic due to its effectiveness or side effects. In the past, medicines that were widely used for runny nose, such as Contact 600 and Havenef, suddenly disappeared. This is because phenylpropanolamine (PPA), which was widely used in nasal cold medicine at the time, caused side effects related to cerebrovascular diseases, such as hemorrhagic stroke.

The United States had already recognized the problem and decided to withdraw it in 2000, but the Korean Ministry of Food and Drug Safety (MFDS, then the Food and Drug Safety Administration) took its time by not immediately imposing a complete ban. Civic groups such as the Pharmaceutical Society for a Healthy Society criticized the Ministry of Food and Drug Safety for not expelling the drug even though its risks were verified, and demanded its immediate expulsion to prevent damage to the public’s health. The Ministry of Food and Drug Safety dragged on for nearly four years, saying it would conduct additional verification, and it was not until 2004 that it finally decided to withdraw the product.

There is also a nose cold medicine that was controversial because it was used to manufacture philopon. It is pseudoephedrine. Since 2006, the U.S. FDA has converted pseudoephedrine from an over-the-counter drug that can be purchased at pharmacies to a prescription drug that requires a doctor’s prescription.

In Korea, there was social controversy in 2013 when two men in their 30s were caught manufacturing Philopon using nasal cold medicine in a studio apartment. Korean health authorities have converted high-dose pseudoephedrine nose cold medicine to a prescription drug. However, low-dose nose cold medicine was kept as an over-the-counter medicine, and even afterward, articles about the manufacture of drugs using pseudoephedrine appeared intermittently.

Dangerous nasal medicine, why is it popular in Korea?

Earlier this year, the European Medicines Agency (EMA) and the UK’s Medicines Regulatory Agency (MHRA) recommended safety measures to avoid the use of pseudoephedrine in people with high blood pressure and kidney disease. This is because they accepted reports that pseudoephedrine can cause life-threatening diseases by reducing blood supply to the brain.

It’s not just this. In the United States, there have been many accidents in the past where infants under the age of 2 died from overdosing on nasal medications containing pseudoephedrine, so the use of nasal medications for infants and young children is still restricted. Last October, the director of France’s National Agency for the Safety of Medical Products (ANSM) appeared on national television and strongly recommended against using pseudoephedrine as a nasal cold medicine due to concerns about side effects.

As such, there are many voices raising caution about the use of nasal medication in foreign countries. This is because there are concerns that not only is it not very effective in treating colds, but it can also cause serious side effects. However, in Korea, a strange phenomenon is happening on the contrary.

As the number of people seeking nasal cold medicine increased due to the influenza and coronavirus epidemics, pharmacies experienced a shortage of nasal cold medicine for a while. In order to respond to the increased demand, the government raised the price of nasal cold medicines such as pseudoephedrine by about 30%, which increased supply and enabled us to use nasal cold medicines more often.

Other countries restrict the use of nasal cold medicine due to safety concerns, but Korea is worried that they will run out of nasal cold medicine. Why should we do that? Even if you catch a nose cold this winter, try to solve it with methods other than medicine if possible. Children and those with high blood pressure or kidney disease should be especially careful.

Lee Dong-geun

https://n.news.naver.com/article/047/0002457013?sid=102