Local pharmaceutical experts said the health authorities did not have to switch extended-release (ER) acetaminophen products to prescription drugs in the wake of the European Medicines Agency’s suspension of marketing such treatments.

Popular modified-release acetaminophen (paracetamol) medicines include Tylenol and Panadol.

According to the minutes of the Ministry of Food and Drug Safety’s central pharmaceutical affairs advisory committee, experts agreed that it is not necessary to change suspended-release acetaminophen products to prescription treatments or discontinue sales.

Members of the panel said acetaminophen did not have a high occurrence rate of abnormal events and the usefulness of modified-release acetaminophen was greater than its risk.

Korea does not have to follow Europe’s move, as the nation has a different healthcare environment, they said.

“Considering the supply volume and abnormal events, acetaminophen is the most commonly used antipyretic analgesic in Korea. The drug’s incidence of abnormal cases is not higher than nonsteroidal anti-inflammatory drugs (NSAIDs)-related pain relievers,” one of the committee members said. “

Another member said, “Although acetaminophen is the most prescribed and used in Korea, it has a low rate of occurrence of abnormal cases. Its side effect on the liver is already well known, so we can fully prepare for it. We cannot conclude that the modified-release tablet’s concentration in the blood is higher than that of the general tablet.”

The member went on to say that suspending acetaminophen was not reasonable because it was the cheapest and safest medicine that doctors could use for rheumatoid arthritis.

“Switching it to a prescription drug is unnecessary, but we need measures such as reducing the unit of packaging to prevent overdose,” the member added.

Yet another member noted that it was undesirable to make the public worry excessively.

“Instead of over-emphasizing the risks, we should gather enough data on overdosing. We need to enhance the drug utilization review (DUR) on acetaminophen-containing therapies including combination drugs, and limit excessive purchases,” the member added.

A consumer representative expressed similar opinions.

“From the viewpoint of consumers, I don’t think we should change it to prescription medicine. But we should reinforce medication guidance at pharmacies. Also, we should collect more abnormal cases, strengthen the warning phrase in the drug manual, and promote more about the warnings to patients,” the member said.

The ministry has recently announced follow-up measures such as packaging and name change of suspended-release acetaminophen as a monotherapy, provision of the DUR information, revision of the drug manual and strengthening of education, and intensive monitoring of side effects in the domestic market.

lhs@docdocdoc.co.kr

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