Painkillers Restricted to People Over 15
The government is to order that some of the nation's best-selling painkillers, Samjin Pharm's Geworin, Bayer Korea's Saridon-A and others be prescribed or sold to people over 15 years of age only.
Based on some experts and civic groups' claims that main substance of the drugs, isopropylantipyrine (IPA), could cause cardiovascular disorders and loss of consciousness, the Central Pharmaceutical Affairs Council said last week that the painkillers should be banned from sale to people under 15. The council is to report the decision to the Korea Food and Drug Administration (KFDA), which is highly likely to accept it and deliver it to local hospitals and chemists.
Previously, the Korean Society for Pharmacoepidemiology and Risk Management said at least six cases were reported in 2002 of side effects from the drug IPA, and the KFDA has identified another three. The group said patients complained of rashes and other hypersensitive conditions and the KFDA reported that the complaints were about hypertension, a common symptom of nephritic syndrome, which causes a heavy leakage of protein into the urine.
It claimed that doctors must inform patients of any possible side effects when prescribing such medicines.
Whether the substance is harmful is debated. It is banned in six countries including the U.S., Canada, New Zealand and Turkey but is used in 21 others, including Germany and Japan.
Pharmaceuticals declined official announcements. ``The KFDA has not made an official announcement of the regulation and we are still waiting for the decision,'' a spokeswoman for Samjin said.
However, the company has already released Junior Geworin, which contains no IPA, and the spokeswoman said the decision won't likely affect sales greatly.
Last year, Chong Kun Dang Pharm recalled its top-selling painkiller Penzal following the dispute over IPA. It instead released Penzal Q, in which ethenzamide replaces IPA.