|
|
 |
 |
 |
|
|
|||
|
||||
|
||||
Chinese Factory Linked to Drug Under Inquiry in U.S. (Heparin)From: Dean Huffman . (dean@thehuffpeople.net)Thu Feb 14 12:47:03 2008
.. Chinese Factory Linked to Drug Under Inquiry in U.S. By GARDINER HARRIS, NY Times 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. http://www.nytimes.com/2008/02/14/business/worldbusiness/14heparin.html?ref=health
|
|
Return to
|
Mail a New Message to the Forum: ob-gyn-l@obgyn.net Forum Administrator: geffrey.klein@obgyn.net Report Technical Problems: webmaster@obgyn.net Last Updated: Wed Jul 2 04:48:49 2008 |
The American Medical Association is no longer designating CME hours for AMA Category II CME credit. However, physicians themselves may self designate learning activities as Category II CME credit hours if they feel it is of sufficient educational merit and meets the formal definitions of continuing medical education. OBGYN.net believes these interaction in this forum meets these criteria. For further information see the AMA web site.