Questions Left on KFDA’s Dilatory Measures on Cold Medicine Containing PPA

In a move related to the banning of cold medicines containing phenylpropanolamine (PPA), a stroke-causing ingredient, the Korea Food and Drug Administration (KFDA) had immediately followed the U.S. Food and Drug Administration’s (FDA) advisory on all the other medicines, but did not follow through with the ban for cough medicines containing PPA.

Also, eight months after the FDA had made its announcement, the KFDA had permitted the sales of cold remedies containing below a specific amount of PPA, neglecting the FDA’s warning. It was found out that the amount of PPA that is applied to the standard all differed.

Accordingly, the course in which it took KFDA four years to ban the sales and use of cold medications containing PPA is raising many suspicions.

KFDA’s Uneven Standards-

The KFDA had banned only the production and sales of appetite depressants, single medications, and medications with a maximum daily dose exceeding 100mg among PPA-containing drugs in July 2001, eight months after the FDA’s advisory. Cold medicines with a maximum daily dose under 100mg could still be continuously produced and sold.

This figure is 25mg higher than FDA’s warning that if PPA is taken in more than 75mg doses per day, the possibility for a stroke goes up 10 times higher.

On the question asking why the permitted standard was fixed on 100mg, a KFDA official said on Thursday, “Countries such as Japan and England are applying the 100mg standard, and so we followed it.”

However, as the KFDA conducted a research project of its own while saying that there is not enough evidence to wholly accept a foreign institute’s judgment and that there may be criticism, the reason they gave for following Europe and Japan’s standard is somewhat doubtful.

Related to this matter, it was found out on Thursday that four days after the FDA had announced their advisory, on November 10, 2000, the Korea Pharmaceutical Manufacturers Association (KPMA) had recommended the KFDA carefully consider banning the sales of PPA-containing drugs sold inside the country since they held under 75mg of PPA.

At that time, the maximum daily dose for Contac 600 (manufactured by Yuhan Corp.) was 80mg, and many of the cold medicines produced domestically held 70 to 100mg of PPA.

Consequently, KFDA’s measures taken on November 2001 meant that they had wholly accepted KPMA’s request.

The Difference in the Measures Taken With Other Medications Following the FDA’s Advisory-

The KDFA has stressed that they had started research to find independent evidence of their own on behalf of their reason to examine the hazards of cold medicine containing PPA and not following the FDA’s measures. However, this is the first time the KFDA has conducted an individual research study and not followed the advisory of an advanced country.

For example, a research study in the U.S. showed that terfenadine, a remedy for rhinitis, caused cardiac arrhythmia. When the FDA recalled medication containing 120mg of terfenadine and complex drugs containing 60mg of terfenadine, it was confirmed that the KFDA took the same measures in January 2000 without conducting research of its own.

According to the report that cisapride, a substance for digestion, caused heart attacks, the FDA limited its prescription in early 2000, and on July 1 of the same year, the KFDA took measures to ban prescriptions of the drug as an optional medication.

On this matter, a KFDA official said, “Terfanadine and cisapride are not used as widely as cold medicines, and we did not judge research to be necessary. The usefulness of the medicine differs by the country, and so there are difficulties in explaining straight measures.”

Chun Moon-ho, president of the Korean Pharmacists for Democratic Society, worriedly said, “[Even if we accept the KFDA’s explanation,] In case that a measure is taken for the safety of a medication in a foreign country, whether to follow this measure or to conduct individual research to decide on medication substance dosage has not been decided on yet, and so there will continuously be confusion.”

Tae-Hoon Lee jefflee@donga.com