Government Bans 167 Cold Medicines

Yesterday the Korean Food and Drug Administration (KFDA) banned distribution of 167 cold medicines containing phenylpropanolamine (PPA), an ingredient mainly used for nasal decongestants.

The KFDA explained that it took the measure following a recent survey reporting that “When cold patients take medicines with PPA, the possibility of cerebral damage is feared to increase, and the risk for high-blood pressure patients goes up.”

The KFDA ordered the destruction of the banned medications, which are manufactured by 75 different pharmaceutical firms.

The banned products include Koritusal syrum (Bukwang Pharmaceutical Co.), Whacol A capsule (Joong-woi Pharmaceutical Co.), Jimikojeong (Daewoong Pharmaceutical Co.) and Koddu syrup (Kolong Pharmaceutical Co.).

The KFDA also banned the importation of PPA and ordered pharmaceutical companies to report the results of the recall and destruction of the products by late September to the administration.

Cold patients who have prescription or purchase cold medicines over the counter should inquire whether PPA is contained in the medicines, added the KFDA.

Studies have shown PPA slightly increases the risk of hemorrhagic strokes.

“People who took cold medicines with PPA and did not suffer hemorrhagic strokes don’t need to worry about it, since the ingredient does not accumulate within the human body. However, from now on patients should always check whether the ingredient is contained or not,” said Yoon Byung-woo of Seoul National University, who led the survey of PPA hazard.

The KFDA said, “The United States and Japan have substituted PPA with pseudoephedrine, which has the same ingredients as PPA, and we are going to consider using the substitute for cold medicines.”

Upon the banning of cold medicines with PPA, some pharmaceutical companies were critical, saying, “We have already substituted PPA with different ingredients for several years.”

Some pharmaceutical companies asked the KFDA to acknowledge their investment in their established brand marketing, and allow them to use the same product names when they put new cold medicines devoid of PPA on the market.

The KFDA is considering their request, but as the measure takes effect in late September when the recall of PPA cold medicines is completed, and the revision of related regulations is to be done through discussion with pharmaceutical companies, the majority of well-known cold medicines is expected to disappear temporarily.

Tae-Hoon Lee jefflee@donga.com