[Desk’s View] MFDS should clarify AAP safety message

Should have delivered a clearer safety message on acetaminophen

Unforeseen moves by U.S.

 

President Donald Trump are having a considerable impact in Korea.

 

After sudden tariff hikes rattled the Korean economy, an unexpected drug safety issue has now emerged.

 

The domestic healthcare market, which is reliant on overseas drugs, is reeling from Trump-related risks.

 

The controversy began on the 22nd when President Trump stated at a press conference that acetaminophen is not safe for pregnant women.

 

He said, “Acetaminophen, widely known as Tylenol, may increase the risk of autism in children if taken during pregnancy.

 

The U.S.

 

Food and Drug Administration will notify doctors of this, and if necessary, recommend restricting Tylenol use during pregnancy.” Acetaminophen, widely known under the brand name Tylenol (Kenvue), is one of the most commonly used fever reducers and pain relievers in Korea.

 

It is generally regarded as relatively safe for pregnant women and young children, which is why healthcare professionals frequently recommend it to such patients.

 

Trump's remarks appear to be based on a recently published report by a research team at the Icahn School of Medicine at Mount Sinai in the United States.

 

This report suggests a possible link between Tylenol use and autism.

 

However, academic communities in Korea and abroad are pointing out that Trump's statement is premature, as scientific evidence linking acetaminophen to autism remains insufficient.

 

The Korean Pharmaceutical Association stated, “Major global health authorities and academic organizations have made it clear that there is insufficient scientific evidence to support such claims at this time.” The Korean Medical Association also dismissed the claims, citing insufficient evidence.

 

KMA spokesman Sung-keun Kim said in a regular briefing, “There is no scientifically established evidence to support the claim that taking Tylenol during pregnancy causes autism in the fetus.” The same sentiment is echoed overseas.

 

WHO spokesman Tarik Jasarevic told reporters at a press briefing, “Evidence remains inconsistent.” The European Medicines Agency (EMA) also stated in a release, “Based on the evidence available to date, no association has been found between the use of paracetamol (the active ingredient name for acetaminophen in Europe) during pregnancy and autism.” However, confusion persists as the US Food and Drug Administration (FDA), the regulatory authority for Tylenol’s home country, has yet to issue an official statement.

 

The stance of the Ministry of Food and Drug Safety (MFDS) is also ambiguous.

 

While the MFDS stated it would receive relevant data from manufacturers and discuss the matter, it has not issued a clear message.

 

It did note, however, that under current approval guidelines, if a pregnant woman experiences a persistent fever above 38°C in early pregnancy, it could affect fetal neural development.

 

In such cases, acetaminophen-based fever reducers and pain relievers may be taken, but the dosage should not exceed 4,000 mg per day.

 

It added that since individual medical situations may vary, pregnant women should consult a healthcare professional before taking any medication containing acetaminophen.

 

This reflects a cautious stance regarding the link between acetaminophen use during pregnancy and autism.

 

This is understood to be a comprehensive reflection of the lack of official statements from the U.S.

 

President, a key ally, and the FDA.

 

Nevertheless, compared to the WHO and EMA stating there is still no clear evidence, this stance appears overly passive.

 

Furthermore, the title of the official press release, “Consult a healthcare professional and take as directed,” seems to shift the burden onto private experts rather than the government.

 

Had the government clearly communicated that, at least for now, evidence is insufficient and that the drug should be taken according to current approved guidelines, it would have alleviated public anxiety.

 

The Ministry of Food and Drug Safety (MFDS), despite being a regulatory body like the FDA or EMA, has faced significant criticism in the past for making decisions based on politics rather than scientific evidence.

 

Of course, it is not entirely independent from government influence, and unlike the FDA or EMA, it lacks manpower and expertise; therefore, direct comparisons may not be fair.

 

Nevertheless, if Korea is to be recognized as a member of the advanced nations and if MFDS truly seeks global recognition as a competent regulatory agency—as it often promotes—then in such controversies, it must deliver clearer, science-first messages.

 

That would undoubtedly strengthen public trust in MFDS by showing that science is prioritized over politics.