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【drug-news】FDA找到肝素问题相关污染物 ？
FDA找到肝素问题相关污染物 ？
March 5, 2008, 2:05 pm
FDA Closes In On Heparin Problems
Posted by Jacob Goldstein
The FDA has taken another step toward figuring out why hundreds of people had serious adverse reactions to the heparin sold by Baxter. A contaminant that’s chemically similar to raw heparin accounts for 5-20% of the active pharmaceutical ingredient in batches of raw heparin that Baxter used to make the blood thinner, the agency said today.
It’s unclear whether the contaminant was introduced as an accidental byproduct of the standard process of making heparin from pig intestines, or whether someone added it intentionally. It’s not even clear exactly what the stuff is. “We do not have a final identification of the compound,” FDA commissioner Andrew C. von Eschenbach said. “We are in the midst of doing very exact analytical work to determine the exact identity is.”
The contaminant was in active pharmaceutical ingredient batches that Baxter buys from a company called Scientific Protein Laboratories. SPL makes raw heparin both at a factory it operates in China as part of a joint venture, and in Wisconsin. The raw material from China goes through the Wisconsin plant before being shipped off to Baxter. It’s unclear whether the contaminant was introduced in Wisconsin or China, FDA said.
Baxter has recalled its heparin, which has been associated with hundreds of serious adverse events and 19 deaths, the FDA said. The heparin being sold by APP Pharmaceuticals, which uses different suppliers than Baxter, does not contain the contaminant, the FDA said.
Update: An SPL statement just landed in our inbox. The company points out that the contaminant hasn’t been definitively proven to be the cause of the adverse reactions. “During the call with the media, FDA speculated that the source of the adverse events may be a contaminant,” the statement says. “It is important to note that this theory is speculation at this point.”
FDA派员现场考查之后: 肝素致命质量问题仍然是迷?
Heparin problems' cause still unknown
Email|Print| Text size – + February 28, 2008
WASHINGTON—U.S. inspectors found some mostly procedural problems at a Chinese factory that supplied the main ingredient for the recalled blood thinner heparin -- but said Thursday they can't yet tell what is to blame for serious side effects.
more stories like this"We're still considering all possibilities," said Food and Drug Administration compliance chief Deborah Autor. "We have not ruled anything out at this point."
Baxter International halted production earlier this month after the blood thinner was linked to four deaths and hundreds of reports of allergic-type reactions, including vomiting, nausea and difficulty breathing.
The FDA has completed an inspection of the Chinese factory, Changzhou SPL, that supplied the active ingredient, and took the unusual step Thursday of posting its draft inspection findings on the agency's Web site. The FDA is under intense scrutiny in the probe, after it acknowledged that an agency mix-up meant the Chinese factory had never been inspected before the heparin began selling.
Inspectors compiled a list of possible problems in how workers ensure they're producing quality drug.
Among the findings:
-- A lack of specific procedures outlining removal of impurities.
-- Workers reprocessed the drug that didn't meet specifications without determining what caused the initial problem.
-- No records showing suppliers' source of the products.
-- Some apparently improperly cleaned and maintained equipment.
Heparin, used to prevent blood clotting, is generally made from pig intestines. In China and other developing countries, tracing the source of animals used to make it can be difficult.
The FDA stressed that inspectors' initial findings are preliminary and must be further investigated. China isn't the probe's only focus; the FDA also is conducting inspections at facilities in the U.S.
The FDA said Thursday that it now has a total of 448 reports of possible problems in patients taking heparin from any manufacturer, but the agency thinks that those associated with the problematic Baxter product number 215.
Baxter hadn't formally recalled all of the problematic heparin vials because the FDA feared doing so would trigger a shortage. Thursday, Baxter took that next step, after the FDA verified that a second U.S. supplier has ramped up to fill the gap.
Of most concern are vials of heparin used in fairly large doses, such as for heart surgery or during dialysis. But also recalled Thursday, in what FDA said was a purely precautionary move, was Hep-Lock, a very diluted product used to prevent blood clots from forming in intravenous medication lines, because it was made with the same ingredient. 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。 Heparin problems' cause still unknown
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作者:admin@医学,生命科学 2010-11-29 17:13
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