包装が似ていて用量を間違えたデニス・クエイドの子どもの件とは違うようだ。 ----------- 　ＦＤＡ(米国食品医薬局)による検査のされていない中国の工場で製造された原料によるヘパリンで350人に被害が生じ、少なくとも４人が死亡した。早期に中国の工場を検査するという。ヘパリンは豚の腸から作られる。バクスターはヘパリンの米国使用量の半分を製造しており、製造中止で供給不足に陥る可能性がある。 　ＦＤＡの現在の検査スピードからすると、米国に製品輸出している全ての国の製薬工場を検査するには13年かかるという。 　昨年末ミズーリ病院で透析を受けている子供が激しいアレルギー反応にみまわれ、公衆衛生当局はヘパリン供給品についての問題に気づき、調査で数百の同様なケースが見つかった。バクスターは最初製品のいくらかを回収したが、問題は持続した。 　ＦＤＡは医師に、可能な限りバクスターの製剤使わないように、非常にゆっくりと患者に注入するように警告した。また、バクスター製ヘパリン使用時にはステロイド類または抗ヒスタミン剤の使用で、起こりうる厳しいアレルギー反応を防止することに役立つと提案した。 ----------------------------------- Chinese Factory Linked to Drug Under Inquiry in U.S. http://www.nytimes.com/2008/02/14/business/worldbusiness/14heparin.html By GARDINER HARRIS Published: February 14, 2008 WASHINGTON ― A Chinese factory that has not been inspected by the Food and Drug Administration is the source for the active ingredient of a critical blood-thinning drug whose production was suspended this week after 350 patients reported ill effects from it. At least four people died after being given the drug, heparin. An F.D.A. spokeswoman, Heidi Robello, said Wednesday that the agency was making plans to inspect the Chinese factory as well as a finishing plant in New Jersey “as soon as possible.” She said that “it was yet to be determined” if the Chinese plant was the source of the problem that led to the spike in reports of problems with the drug’s use. Heparin is made from pig intestines. Ms. Robello said that she did not know whether the pigs used to produce the suspended product, made by Baxter International, came from China. Heparin is used widely in dialysis, heart surgery and chronic care hospitals. Baxter manufactures half of the nation’s supply of the drug, and the company’s suspension of its production of multiuse heparin vials is expected to lead to shortages. A Baxter spokeswoman, Erin Gardiner, said her company bought the active ingredient for the drug from another concern, which she would not identify. She said that company had plants in the United States and China. The Government Accountability Office recently reported that at its current inspection pace, the F.D.A. would need at least 13 years to inspect every foreign drug plant that exports products to the United States. The office, an independent arm of Congress, also found that the F.D.A.’s computer systems were deficient and it had little idea how many plants had been approved for exports to the United States. The quality of Chinese products became a source of concern last year after federal officials discovered that a pet food ingredient shipped from China contained toxic levels of melamine, which was added to make it appear higher in protein. Many pets became ill, and some died. Officials also issued alerts about Chinese seafood, some of it found to be contaminated. A scandal involving Chinese-made toothpaste that proved poisonous in Panama led to another alert. Chinese officials have promised to strengthen oversight of the production and export of foods, drugs and medical devices. Public health officials noticed a problem with heparin supplies late last year when children undergoing dialysis at a Missouri hospital had severe allergic reactions. As officials investigated, they discovered hundreds of similar cases. Baxter initially recalled some of the product, but the problems persisted. The F.D.A. decided to allow Baxter to deliver heparin that it was in the midst of shipping for fear that a total recall would lead to an immediate and severe shortage of the drug. The F.D.A. cautioned doctors to use as little of the Baxter drug as possible and to infuse it into patients very slowly. The agency also suggested that doctors consider giving steroids or antihistamines along with the Baxter heparin to help prevent possible severe allergic reactions. ------------------------------ Baxter Issues Urgent Nationwide Voluntary Recall of Heparin 1,000 Units/ml 10 and 30ml Multi-Dose Vials NDC NUMBERS 0641-2440-45, 0641-2440-41, 0641-2450-45 and 0641-2450-41; LOTS: 107054, 117085, 047056, 097081, 107024, 107064, 107066, 107074, 107111 http://www.fda.gov/oc/po/firmrecalls/baxter01_08.html Media Contacts: Erin Gardiner, (847) 948-4210 Christopher King, (847) 948-4274 FOR IMMEDIATE RELEASE -- DEERFIELD, Ill., January 25, 2008 – Baxter Healthcare Corporation has announced the voluntary recall of nine lots of heparin sodium injection 1000 units/mL 10mL and 30mL multi-dose vials. The company began recalling the lots on January 17, 2008 as a precautionary measure due to an increase in the number of reports of adverse patient reactions that may be associated with the product. Baxter is conducting a thorough investigation of these reports to identify the cause of the increase in allergic-type reactions. Adverse patient reactions have included: stomach pain or discomfort, nausea, vomiting, diarrhea, decreased or low blood pressure, chest pain, fast heart rate, dizziness, fainting, unresponsiveness, shortness of breath, feeling your heart beat strong or fast, drug ineffectiveness, burning sensation, redness or paleness of skin, abnormal sensation of the skin, mouth or lips, flushing, increased sweating, decreased skin sensitivity, headache, feeling unwell, restlessness, watery eyes, throat swelling, thirst and difficulty opening the mouth. Some of these reactions may be severe or life threatening. Heparin is a prescription, injectable blood anticoagulant (also called a blood thinner). The 1,000 units/mL multi-dose vials are primarily used for hemodialysis and cardiac invasive procedures. To date, the company has not observed a significant increase in adverse event reports occurring with any other of its heparin presentations. Customers have been instructed to discontinue use and segregate the recalled product from the rest of their inventory. Customers should then contact Baxter to arrange for return and replacement product. Customers with recalled product purchased indirectly should contact their wholesaler or distributor for return and replacement product. Customers with questions may contact Baxter at 1-800-667-0959. Representatives are available Monday through Friday from 7 a.m. to 6 p.m. CT. Baxter International Inc. through its subsidiaries, assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives. For more information about Baxter, visit www.baxter.com.

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