Bayer’s Saridon-A Among 28 Painkillers Banned To Those Under 15 In Korea

SEOUL - Amid rising claims that it isn't moving fast enough to counter public concern over the safety of OTC painkillers, Korea FDA has banned Bayer Korea's painkiller Saridon-A , Samjin Pharm's Geworin and 26 other products from being prescribed or sold over the counter to those under 15 years of age.

Under the new guidelines, everyone - except those under 15 - who do not see improvements in their condition after five to six doses will also be prevented from taking the medicine further, KFDA said.

KFDA made the measure effective March 3 -one day after the Central Pharmaceutical Affairs Council reported to KFDA that the painkillers should be restricted -first to those under 15. The report was based on months-long claims raised in October 2008 by a pharmacists group that the main substance of the drugs, isopropylantipyrine (IPA), could cause cardiovascular disorders and loss of consciousness.

The Korean Society for Pharmacoepidemiology and Risk Management reported in December that South Korea should take greater steps to ensure the safety of IPA-containing painkillers. The group said the drugs caused at least six cases of adverse events as far back as 2002, and it counted six more recent cases that should have highlighted the risks. Korea FDA identified three more cases in early December. IPA-containing painkillers are made in South Korea by Chong Kun Dang, Samjin Pharm, Dong-A Pharmaceutical and Bayer Korea (PharmAsia News, Dec. 29, 2008).

"We got the council's report on March 2, and put that into effect the next day by telling hospitals and pharmacists not to sell the painkillers to those under 15," said a KFDA official, requesting anonymity. "We immediately put that result of the council's study into action."

Another KFDA official said Bayer's Saridon-A is the only multinational pharma company painkiller restricted by the KFDA action.

Saying that drugs containing IPA are banned in six countries including the U.S., Canada, New Zealand and Turkey, Korean doctors and pharmacists said patients complained of rashes and other hypersensitive conditions. KFDA, however, said the complaints were related to hypertension, a common symptom of nephritic syndrome, which causes a heavy leakage of protein into the urine.

"Considering the scope of the council's recent study, we just don't understand why it took nearly five months to complete the study," Kang A-Ra, a spokeswoman for Korean Pharmacists for Democratic Society, which raised the worries in October, said. "To more efficiently deal with these issues in the future, KFDA has to enhance its infrastructure of reporting systems for side effects, collection of statistics and others needed for drug safety management."

Korea Pharmaceutical Manufacturers Association Spokesman Jung Cheol-Won told PharmAsia News that products such as Janssen Korea's Tylenol and Hanmi Pharm's Suspen ER , which contain acetaminophen, are expected to replace IPA products.

Since its global launch in 1934, Saridon-A, has been one of three leading painkillers in South Korea. Samjin's Geworin has been marketed in South Korea for 20 years.

Last year, Chong Kun Dang Pharm recalled its top-selling painkiller Penzal amid rising concerns about IPA, and released Penzal Q , which replaces IPA with ethenzamide.

China's Supreme Court recently accepted Southwest Pharmaceutical's appeal to have a retrial of its trademark violation case with Roche over the Saridon (sanlietong) trademark. The lawsuit between Southwest Pharmaceutical and Roche has dragged on for more than a decade; and Roche recently transferred Saridon's production and trademark to Bayer (PharmAsia News, June 16, 2008).

- Peter Chang ([email protected])