Drugs With PPA Can Cause Strokes: KFDA


By Na Jeong-ju
Staff Reporter
The Korea Food and Drug Administration (KFDA) on Saturday banned production and sales of 167 cough and cold medications containing phenylpropanolamine (PPA), an ingredient that can cause hemorrhagic strokes.

Following the total ban of PPA, 75 pharmaceutical manufacturers are required to remove PPA-containing pills, syrups and tablets off shelves nationwide.

Consumers are also advised to stop using over-the-counter (OTC) and prescription medicines having the harmful substance. The regulator asked doctors and pharmacists to stop prescribing or selling the products immediately.

The measure is based on the result of a years’ research by the KFDA that has concluded PPA could cause hemorrhagic stroke for medicine-takers.

The KFDA said it has ordered the drug manufacturers to recall their PPA-containing products completely within the next month for disposal.

The measure came four years after the U.S. Food and Drug Administration issued a public health advisory in November 2000 concerning the use of PPA hydrochloride, which was being widely used for diet and cold pills, and requested all drug companies discontinue marketing products containing PPA.

Immediately after the FDA advisory, the Korean regulator took similar measures to ask pharmaceutical firms to voluntarily stop producing and selling the listed cold relievers.

Drugs with the PPA have almost disappeared in the U.S. following the warning, but drug companies in South Korea have continued to make and sell drugs using the PPA, and the KFDA had done little to ban the harmful substance.

Public anger grew Monday over the belated ban for the substance. Critics argued the KFDA released the list of products containing PPA on the weekend to avoid media attention on the issue and a possible backlash from pharmaceutical firms.

The 167 banned products include some popular OTC and prescription medicines such as Contac 600 and 400 manufactured by Yuhan Corp., Facol-F by Choongwae Pharma, Suspen Cold and Cospen by Hanmi Pharm., and Colmin by Yungjin Pharm.

Wyeth Korea, BMS Korea, Kolon Pharmaceuticals, Hyundai Pharm., Kwangdong Pharmaceutical and Daewoong Pharmaceutical are also among the 75 manufacturers to face mass recalls.

PPA is an ingredient used in many over-the-counter and prescription cough and cold medications as a decongestant. Some Korean manufactures have been arrested for illegally using PPA to make OTC diet products.

In 2001, the KFDA banned the use of PPA as a substance to contain appetite, following in the footsteps of the U.S. and Japan, as more medical evidence proving the danger of PPA was discovered.

In early 2000, scientists at Yale University’s School of Medicine released a report entitled ``Phenylpropanolamine & Risk of Hemorrhagic Stroke: Final Report of the Hemorrhagic Stroke Project.’’ The study showed taking PPA increases the risk of hemorrhagic stroke for individual patients.

jj@koreatimes.co.kr