"Tylenol Causes Autism During Pregnancy," Trump's Remarks Cause Tension in Pharmaceutical Industry

Industry Fears a Repeat of the COVID-19 Era When Tylenol Was Recommended... "Authorities Need to Provide Explanation"

Ministry of Food and Drug Safety Requests Opinions from Manufacturers and Importers of Preparations Containing Acetaminophen

 Tylenol [Provided by Yonhap News TV]

The domestic pharmaceutical industry is on edge following remarks by then-U.S. President Donald Trump regarding the potential link between the popular fever and pain reliever 'Tylenol' and autism.

Concerns are being raised that if consumers become agitated by Trump's remarks, which lack clear medical evidence, a situation similar to the sharp decline in sales of fever and pain relievers during the COVID-19 pandemic, when domestic health authorities recommended Tylenol, could reoccur.

According to the pharmaceutical and bio-industry on the 24th, President Trump stated at a press conference at the White House on the 22nd (local time) that studies have shown Tylenol use during pregnancy increases the risk of autism, and that the Food and Drug Administration (FDA) would notify doctors accordingly.

Kenvue, the manufacturer of Tylenol, countered in a statement on the same day, "Independent and reliable scientific research clearly shows that acetaminophen does not cause autism. We strongly disagree with any claims to the contrary and are deeply concerned that such assertions could pose serious risks to pregnant women's health."

Kenvue emphasized, "Acetaminophen is the safest pain reliever for pregnant women during pregnancy. Not taking it to treat fever can increase the risk of miscarriage, autism, and birth defects."

British Health Secretary Wes Streeting also refuted on the 23rd President Trump's claim that Tylenol use during pregnancy increases the risk of autism, stating it is untrue. Similarly, Professor Lori Thorp of the London School of Hygiene & Tropical Medicine, whose child has autism, advised focusing on the numerous credible studies showing no link between Tylenol and autism.

However, despite Kenvue's explanation, the domestic pharmaceutical industry is concerned that consumers, swayed by Trump's remarks, may shun fever and pain relievers containing acetaminophen, the active ingredient in Tylenol.

This is because the U.S. FDA's decision to change the acetaminophen label to include "increased risk of giving birth to an autistic child if taken by pregnant women" could impact many domestic fever and pain relievers using the same ingredient.

Some are also concerned that a situation similar to the COVID-19 pandemic could reoccur, when domestic sales of fever and pain relievers plummeted after then-Commissioner of the Korea Disease Control and Prevention Agency (now Minister of Health and Welfare) Jeong Eun-kyeong stated that "simple fever and pain relievers without anti-inflammatory effects, like Tylenol, are appropriate to take if experiencing uncomfortable symptoms after vaccination."

An industry official said, "Since President Trump's remarks, there seem to be more inquiries at pharmacies from pregnant women in Korea about what medication they can take for body aches. We are closely monitoring whether a situation similar to the Tylenol shortage crisis and a sharp decline in domestic acetaminophen fever and pain reliever sales during the COVID-19 pandemic, due to official 'Tylenol' statements, will occur."

Therefore, it is argued that domestic health authorities need to swiftly release a statement that can reassure consumers, including pregnant women.

Another industry official commented, "Even if pharmaceutical companies explain that it is safe, consumers tend not to believe it until an official announcement from the authorities is made. Given that medical studies show no increased risk of autism with acetaminophen use during pregnancy, it would be beneficial for the authorities to provide a clear explanation about acetaminophen to alleviate consumer anxiety."

This points to the need for food and drug administration based on scientific evidence, similar to how the Ministry of Food and Drug Safety, following the detection of the carcinogen 'N-nitrosodimethylamine' (NDMA) in Valsartan, an active pharmaceutical ingredient for high blood pressure medication from China in 2018, announced the results of an impact assessment reflecting actual patient usage, concluding a very low additional risk of cancer.

In response, the Ministry of Food and Drug Safety stated that it will request opinions and data from manufacturers and importers of preparations containing acetaminophen regarding the U.S. government's Tylenol-related announcement, and will carefully review the relevant data and evidence. Yonhap News