[e-drug] Phenylpropanolamine (PPA) Banned in Korea and FDA Chief Resigns

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E-drug: Phenylpropanolamine (PPA) Banned in Korea and FDA Chief Resigns
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[Copied as fair use. KM]

Phenylpropanolamine (PPA) Banned in Korea and FDA Chief Resigns 

The Ministry of Health and Welfare recently concluded that the Korean
Food and Drug Administration (KFDA) have taken belated measures to ban
PPA-containing cold and cough medicines. 

"The negligence of duty and lukewarm attitude of the KFDA officials in
handling the case put the public health in serious danger," the ministry
said in a report. "The KFDA failed to report the case to the ministry
and consult with related agencies, without recognizing the importance of
the case." The report, an outcome of the ministry's week-long
investigation into the KFDA's handling of cold medications containing
PPA, that is associated with hemorrhagic strokes, signified the KFDA had
made serious mistakes and failed to fulfill its duty to protect public
health. 

On August 1, 2004, the KFDA banned production and sale of about 170
prescription and over-the-counter cold remedies containing PPA which
were manufactured by 75 pharmaceutical firms. 

On August 9, Shim Chang-koo, the KFDA Commissioner stepped down, took
responsibility for the scandal surrounding a delayed ban on the
PPA-containing medications. 

"I decided to tender my resignation to take responsibility for the
scandal," Shim told a news conference in his office in Seoul. 

Shim's resignation is seen as the beginning of a shake-up of the KFDA
and its monitoring system for drug safety. The ministry said it will
install an independent committee comprising medical experts and consumer
groups to strengthen monitoring of drugs and for research of the
possible side effects of drugs on sale. 

Despite the ministry's action, many questions still remain. Suspicions
have emerged that the KFDA attempted to protect pharmaceutical firms and
downplay the risk of the PPA-containing drugs. 

Nine medical professors undertook research from March 2002 to June 25,
2004. Their research was financed by the pharmaceutical firms producing
the PPA products. The KFDA was criticized for delaying the findings of
the study, which concluded that PPA-containing drugs may be associated
with strokes. 

Yuhan Corp, Choongwae Pharma, Hanmi Pharm, Yungjin Pharm, Wyeth Korea
and BMS Korea are some of the 75 manufacturers. 

The KFDA has been under fire for downplaying the risk of the
PPA-containing drugs. The drug agency did not mention the level of risk
in its press release on July 31, although it was aware of the fact that
use of the PPA increases the likelihood of hemorrhagic strokes among
people over the age of 30, especially women. 

Regulators last week found one of the nearly 170 banned medicines
received a sales permit on July 20, days after the KFDA received the
research results on June 15. Another 13 cold medicines containing PPA
obtained sales permits after July 2001, after the government requested
pharmaceutical firms to refrain from manufacturing PPA-containing drugs.


The Board of Audit and Inspection in Korea said that it will investigate
the handling of the PPA drugs by the health ministry and the KFDA and
the relationship between the KFDA and pharmaceutical firms involved. 

Source: Korean newsmedia August 2004 

[Editor's Note: In November 2000, the U.S. FDA took steps to remove PPA
from all drug products and requested that all drug companies discontinue
marketing products containing PPA following the release of the Yale
study. Kernan WN, Viscoli CM, Brass LM, et al. Phenylpropanolamine and
the risk of hemorrhagic stroke. N Engl J Med. 2000;343:1826-32.] 

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