Drug Agency Bans 167 Cold Medicines Over Stroke RiskAug 2, 2004 | The Korean Herald
The government ordered a ban on the prescription and manufacturing of cold medicines containing Phenylpropanolamine yesterday, citing risk of brain stroke, especially among women.
Nearly 170 medicines manufactured or imported by 75 companies are subject to the government interdiction, the Korea Food & Drug Administration said. The major companies included Yuhan Corporation, Choongwae Pharma Corp., Daewoong Co. and Hyundai Pharm.
PPA is an ingredient that was used in many over-the-counter and prescription cough and cold medications as a decongestant and in weight loss products.
At issue is hemorrhagic stroke, which causes bleeding into the brain or into tissue surrounding the brain.
The alleged relation of PPA and increased risk of hemorrhagic stroke is based on a recent government-commissioned examination of more than 900 local patients suffering from the disease, officials said.
In November 2000, after warnings by U.S. Food & Drug Administration, the government asked drug companies to voluntarily reformulate their products to exclude PPA. Some of drugmakers and import companies complied with the government recommendation but many of them did not.
Some local pharmaceutical companies reformulated their medicine exported to the United States but continued to manufacture PPA-containing medicine for the local market, a government official said.
Seventy-five drug import companies or manufacturers are banned from manufacturing, importing and shipping the cough medicines and required to take them off shelves and dispose them.
According to the U.S. FDA, taking PPA increases the risk of hemorrhagic stroke in women and men may also be at risk. Although the risk of hemorrhagic stroke is very low, KFDA recommended that consumers not use any products that contain PPA.
The drug companies may face a series of lawsuits by patients, consumer rights groups say.
"Those who took medicines containing PPA were twice more likely to suffer from hemorrhagic stroke than those who did not," said a Seoul National Univeristy professor who participated in the investigation.
A controversy over the ban is expected as some of the companies plan to raise objections to the KFDA study.
Crititcism of the KFDA also came from the general public. Many citizens criticized the KFDA for making the announcement on a weekend when people were less likelly to be paying attention to news developments.
They also said the government should have imposed a formal ban four years ago rather than request voluntary compliance that failed to adequately protect public health.