汚染ヘパリンは11ヶ国で見つかり 米国での死者は81人に

 中国原料の汚染ヘパリン製剤は11ヶ国の薬剤から検出され、米国での関連死者は81人に上ると発表された。しかし中国当局は最終的に製造された米国の工場の査察を強く主張した。問題を起こしたのがヘパリンまたはその汚染物であるという強固な証拠を持っていないとも言っている。
 FDAは、汚染されたヘパリンを11か国(オーストラリア、カナダ、中国、デンマーク、フランス、ドイツ、イタリア、日本、オランダ、ニュージーランド、および米国)に供給した12の中国の会社を同定した。汚染ヘパリンによる発症は11月に始まり2月まで続いたが、安価なヘパリン類似作用物質である過硫酸化コンドロイチン硫酸塩を含んだヘパリン・ロットは2006年初頭に製造されたものだという。
 FDAが外国のプラントの完全な検査を開始するには少なくとも5600万ドルの追加費用が来年必要である。2年ごとに中国の薬剤プラントを検査するには毎年少なくとも1500万ドルが必要である。ブッシュ政権はFDAに資金提供する予定はない。現在の検査ペースでは外国の医療機器プラントの検査に少なくとも27年、薬剤プラントの検査に13年、全ての外国の食物プラントの調査に1,900年が必要である。
 連邦議会での提案として内外のメーカーに検査代金を課してFDA資金とする案がある。FDAは、中国の3つの都市で検査事務所を開く計画を発表したが中国政府の許可が必要であり、中国政府が認めるかどうかわからない。
 米国で死者が集中した理由として、米国の医師は大量に急速に薬剤を使用することが関係している可能性がある。
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ヘパリン製剤関連死亡は62人と発表
http://kurie.at.webry.info/200804/article_12.html
世界を危険にさらす薬剤の恐怖
http://kurie.at.webry.info/200804/article_3.html
ヘパリン混入異物判明、コンドロイチン硫酸加工物
http://kurie.at.webry.info/200803/article_31.html
汚染ヘパリン製剤問題の核心はFDAにある/米国
http://kurie.at.webry.info/200803/article_28.html
全ての輸入ヘパリン製剤の汚染検査を
http://kurie.at.webry.info/200803/article_26.html
中国産原料ヘパリン製剤 国内でも自主回収
http://kurie.at.webry.info/200803/article_17.html
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ヘパリン剤の副作用問題、輸入製剤の原薬から不純物検出
http://www.yomiuri.co.jp/national/news/20080422-OYT1T00739.htm
 人工透析などの際に血液凝固を防ぐために使われる「ヘパリンナトリウム製剤」の副作用問題で、国内2社が輸入した製剤の原薬から不純物が検出されていたことが22日、厚生労働省などの調べでわかった。
 この問題は、米バクスター社などの製品を使った米国の患者81人が先月末までに、アレルギー反応で死亡して発覚した。検出された不純物は、製剤の主成分であるヘパリンと似た「過硫酸化型コンドロイチン硫酸」。副作用との因果関係は不明だが、米食品医薬品局(FDA)が原薬を供給していた中国企業を調査したところ、提出された試料から、本来は含まれていない過硫酸化型コンドロイチン硫酸を検出。その後、他国の複数の企業の原薬からも見つかった。
 副作用発生を受け、厚労省が国内の各企業に製剤や原薬の検査を指示した結果、2社が輸入した原薬に含まれていることが判明した。製剤からは検出されなかったものの、2社はそれぞれドイツと中国の企業から不純物を含んだ原薬を輸入・保管しており、このうち中国企業は米バクスター社にも出荷していた。
 国内では先月、製剤を製造・販売していた別の3社が、米バクスター社と同じ供給元(米国)の原薬を使っていたため、製品を自主回収している。しかし、この不純物は、国内のヘパリン製剤会社が22日に導入を決めた厳格な検査方法で確認できるとして、厚労省は、問題のない製剤については出荷を認めることを決めた。
(2008年4月22日22時46分 読売新聞)
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F.D.A. Identifies Tainted Heparin in 11 Countries
http://www.nytimes.com/2008/04/22/health/policy/22fda.html?_r=1&ref=health&oref=slogin

By GARDINER HARRIS
Published: April 22, 2008

WASHINGTON ― A contaminated blood thinner from China has been found in drug supplies in 11 countries, and federal officials said Monday they had discovered a clear link between the contaminant and severe reactions now associated with 81 deaths in the United States.

But a Chinese official disputed the assertion that the contaminant found in the drug, heparin, caused any deaths and insisted that his country’s inspectors be allowed to inspect the American plant where the finished heparin vials were made. He said any future agreement to allow American inspections of Chinese firms should be reciprocal.

“We don’t have a strong evidence to show that it is heparin or its contaminant that caused the problem,” said the official, Ning Chen, second secretary at the Chinese Embassy.

Mr. Chen said that illnesses associated with contaminated heparin had occurred only in the United States, which he said suggested that the problem arose in this country.

Dr. Janet Woodcock, director of the Food and Drug Administration’s drug center, said that German regulators uncovered a cluster of illnesses among dialysis patients who took contaminated heparin. She said Chinese officials had conceded that heparin produced in their country contained a contaminant, though they say it was not connected to the illnesses.

“Heparin should not be contaminated, regardless of whether or not that contamination caused acute adverse events,” Dr. Woodcock said. “We are fairly confident based on the biological information that we have had that this contaminant is capable of triggering these adverse reactions.”

The dispute is a sign of growing tensions between China and the United States over the safety of Chinese imports. China has in recent years exported poisonous toothpaste, lead-painted toys, toxic pet food, tainted fish and now, contaminated medicine.

Bills to require far more aggressive inspections of Chinese products and companies are being proposed by members of Congress. Hearings are scheduled for Tuesday in the House and Thursday in the Senate.

China has lurched between defensiveness and cooperation on issues of product safety. Last year, it initially blocked the F.D.A. from investigating tainted pet food and accused foreign forces of exaggerating the issue. Then in July, China said that it had executed its former top food and drug regulator for taking bribes and promised reforms.

The F.D.A. sent a warning letter on Monday to Changzhou SPL, the Chinese plant identified as the source of contaminated heparin made by Baxter International in the United States. It warned that the plant used unclean tanks to make heparin, that it accepted raw materials from an unacceptable vendor and that it had no adequate way to remove impurities.

Heparin is made from the mucous membranes of the intestines of slaughtered pigs that, in China, are often cooked in unregulated family workshops. The contaminant, identified as oversulfated chondroitin sulfate, a cheaper substance, slipped through the usual testing and was recognized only after more sophisticated tests were used.

The F.D.A. has identified 12 Chinese companies that have supplied contaminated heparin to 11 countries ― Australia, Canada, China, Denmark, France, Germany, Italy, Japan, the Netherlands, New Zealand and the United States. Deborah Autor, director of compliance at the F.D.A.’s drug center, said the agency did not know the original source of all the contamination or the points in the supply chain at which it was added.

Officials have discovered heparin lots that included the cheap fake additive manufactured as early as early as 2006, although a spike in illnesses associated with contaminated heparin began in November and persisted through February, officials said.

Separately, the Government Accountability Office will release a report on Tuesday showing that the F.D.A. would need to spend at least $56 million more next year to begin full inspections of foreign plants. It would need to spend at least $15 million annually to inspect China’s drug plants every two years, which is the domestic standard.

Bush administration officials have acknowledged problems associated with poor inspection of overseas plants and have plans to improve the situation. But President Bush’s budget does not provide the F.D.A. with funds to hire more inspectors.

At its present inspection pace, the F.D.A. would need at least 27 years to inspect every foreign medical device plant that exports to the United States, 13 years to check every foreign drug plant and 1,900 years to examine every foreign food plant.
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Proposals circulating on Capitol Hill would increase the agency’s financing and charge domestic and foreign manufacturers fees to pay for inspections.

“Even the Bush administration seems to understand the potential peril that these foreign firms pose, but they offer only vague plans to address the problems and they refuse to spend more than a fraction of the money needed to protect the public,” said Representative John D. Dingell, a Michigan Democrat who leads the House Committee on Energy and Commerce.

The F.D.A. has announced plans to open inspection offices in three Chinese cities, but the agency has yet to get permission from the Chinese government. Mr. Chen said any inspection agreement should be reciprocal. “Will the U.S. government accept the Chinese F.D.A. to set up in the United States?” he said.

Dr. Woodcock said the Chinese had agreed to test heparin lots before allowing them to be exported. But Dr. Moheb Nasr, director of the drug agency’s office of new drug quality assessment, said that the Chinese test might not be sensitive enough to identify the contaminant.

Dr. Woodcock assured patients, however, that all heparin supplies in the United States had been tested with the most sensitive assays and had been found to be uncontaminated.

Scientific Protein Laboratories and Changzhou SPL said the company regretted the agency’s decision to send a warning letter that, it said, did not reflect the company’s current safety practices. The company said it had no way of detecting a contaminant present in heparin supplies throughout China.

Baxter International, which bought heparin ingredients from SPL and sold the finished drug in the United States, said that its tests confirmed that the contaminant could cause illness. It disputed the F.D.A.’s analysis that its product was linked with 81 deaths, saying it had identified only 5 in which its product “may have contributed to the adverse outcome, though there is not yet enough medical data available to draw a firm conclusion that the reaction caused the death.”

Deaths linked to the drug may have been concentrated in the United States because American doctors may be more likely to use large, quickly infused amounts of the drug, said drug officials. Also, the F.D.A. may track serious side effects better than its counterparts abroad.

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