Heparin recall ordered Posted
by Liz at 02/29/08 09:25 AM
Late yesterday, Baxter International ordered a full-scale recall on the blood thinner Heparin. Up to 21 people now may have died and hundreds have suffered adverse reactions from the Baxter made product. A recall was put off until now, due to concerns over a shortage.
FDA officials said at a news conference yesterday that they had inspected the Chinese facility that provided the active ingredient to Baxter, although things are still unclear:
Among the potential problems they found was a failure to properly follow the steps for identifying impurities and deficiencies related to manufacturing equipment. According to a redacted inspection report released by the agency, the SPL plant appeared to have made at least some heparin with “material from an unacceptable workshop vendor.” The vendor was not identified.
And this inspection came a little too late:
The F.D.A. admitted this month that it had violated its own policy by failing to inspect SPL, located west of Shanghai, before the factory began shipping the heparin ingredient to Baxter in 2004. China’s drug agency also did not inspect the plant.
Janet Woodcock, acting director of the FDA's Center for Drug Evaluation and Research admitted to Congresswoman Rosa DeLauro (D-CT) at a hearing Wednesday that the FDA only inspects about 10% of the foreign facilities shipping drugs and ingredients into the US.
comments
(4)
1
Posted by Peter Jones at 02/29/08 07:08 PM
Dear Congressman,
Here are pictures of where Baxter International gets its heparine: http://online.wsj.com/article/SB120352438415380201.html
Oh my GOD! Baxter International is buying drugs made from pig intestines processed in the back yards of Chinese peasants!!!!!! And our vaunted FDA doesn't inspect and Baxter doesn't inspect. What the hell is going on?
These are not just any drugs. Heparin is used in every heart operation and thousands of other operations. It is taken by thousands of stroke victims every day.
Are you concerned? How can I trust the drugs I get at the pharmacy if this is going on? Please help me understand that!
Blood Thinner Might Be Tied to More Deaths
http://www.nytimes.com/2008/02/29/us/29heparin.html?ex=1362027600&en=31e01a204a05796b&ei=5088&partner=rssnyt&emc=rss
2
Posted by J. Oleck at 03/02/08 02:51 PM
My daughter received heparin and suffered from complications
The doctors pressured the use of heparin even though her tests
said she did not need it. My husband used to inspect drug
manufactures for the FDA I cannot believe that when his child
needed help she was given next to garbage.
3
Posted by JIM at 03/14/08 08:59 AM
The FDA is an organization that is not doing its job. People should be outraged and call for those responsible to step down. Why are we importing food and medical supplies from Japan, China and other foreign countries? Do you think any of our politicians would be exposed to this type of treatment? Americans who believe government will protect them are foolish. Americans need to demand change not politely ask for it or else nothing will change.
Our country has been taken over because American refuse to get involved but in the end every American will be effected. Our country is no longer what it was our job base is sliding overseas our industries disappearing. Over 47 million Americans Cannot afford medical and for those who can the waiting rooms are full and a four hour wait to be seen is not uncommon unless of course you are a politician.
Wake up my fellow Americans! Remember what it took to change the Vietnam war. It will take every bit that type of action to change America today.
4
Posted by Ann at 03/14/08 10:38 AM
I think we should concentrate on making our drugs here in the USA where we have better standards to insure the drugs we purchase at very high prices are safe and will not kill us!
