important warnings and instructions for Heparin Sodium Injection use

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Ross

Ross

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FDA informed healthcare professionals of important warnings and instructions for Heparin Sodium Injection use. There have been reports of serious adverse events including allergic or hypersensitivity-type reactions, with symptoms of oral swelling, nausea, vomiting, sweating, shortness of breath, and cases of severe hypotension. Most events developed within minutes of heparin initiation although the possibility for a delayed response has not been excluded. The reports have largely involved use of multiple-dose vials. However, there have been several cases in which product from multiple, single-dose vials have been combined to administer a bolus dose. Heparin sodium is an anticoagulant (blood thinner) that is used in patients undergoing kidney dialysis, certain types of cardiac surgery, and treatment or prevention of other serious medical conditions, including deep venous thrombosis and pulmonary emboli. Heparin treatment is initiated using high doses (5000-50,000 units) given directly into the blood stream (intravenously) as a bolus. Serious adverse events have recently been reported in patients who received these higher bolus doses.

The manufacture of multiple-dose vials of heparin sodium has been suspended pending the completion of an extensive ongoing investigation to determine the root cause of the problem. Because heparin sodium is a medically necessary product and serious public health consequences would result if there were a sudden shortage of the drug, the multiple-dose vials of heparin sodium manufactured by Baxter that are currently in distribution will not be recalled. See the FDA Public Health Advisory for Agency recommendations to healthcare professionals on the use of heparin sodium for injection.

Read the complete 2008 MedWatch Safety Summary including a link to the FDA Public Health Advisory, Q & A Document, and News Release regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#HeparinInj2
 
Manufacturer Halts Production of Blood Thinner Heparin
02.11.08, 12:00 AM ET


MONDAY, Feb. 11 (HealthDay News) -- Baxter HealthCare Corp., which produces half of the blood thinner heparin sold in the United States, said Monday that it was temporarily suspending production of its multi-dose injectable form of the drug following reports of serious allergic reactions and possibly four patient deaths. http://www.forbes.com/forbeslife/health/feeds/hscout/2008/02/11/hscout612578.html
 
This thread has application to several Forums, especially the Pre-Surgery Forum and Anti-Coagulation Forum.

It's not clear to me which single Forum would be most appropriate.

Since Heparin is used in almost all surgeries, all patients need to be aware of the dangers.

'AL Capshaw'
 
Is anyone really surprised

Is anyone really surprised

Our pets have died by the tens of thousands, our children made ill (lead paint on toys) all from Chinese imports.

It seems they're working their way up the food chain. Quite frankly I'm not at all surprised. Is anyone?

On a recent Canadian TV program "Marketplace" a manufacturer of vitamins and supplements (I think it was Jamieson) visited a Chinese lab and stated on camera that conditions were appalling.

An acquaintence of mine, a university professor, an American, returned home from his Chinese business trip said he was worried about getting sick because the place was filthy. He was there on university business, he had a private escort/security officer and was housed in the best hotels. VIP all the way.

I shudder to think of consequences when mechanical valves are manufactured there.
 
Important warnings and instructions for Heparin Sodium Injection

Important warnings and instructions for Heparin Sodium Injection

Todays news said the FDA is sending inspectors to China this week to investigate the manufacture of this drug. Hope they check out who is making the bad warfarin that myself and someone I know got recently. Just know thats where it came from.
 
heparin recall

heparin recall

Back in January there was a recall of a certain batch of heparin that was causing blood infections I think it had bacteria of some sort from what I remember, not really sure. Do they make our medications in Japan really?

alpha 1
 
lance said:
Our pets have died by the tens of thousands, our children made ill (lead paint on toys) all from Chinese imports.

It seems they're working their way up the food chain. Quite frankly I'm not at all surprised. Is anyone?
Click to expand...

No one wants to face the fact that everybody wants to pay the lowest price for everything, and due to the huge demand for lots of products, manufacturing has been driven to places like China. I think for the most part, companies are just trying to keep up with our insatiable demand for all kinds of stuff - toys to drugs.

Patty
 
US election--splendid opportunity

US election--splendid opportunity

Were I an American I would be questioning the presidential candidates on their views about how they plan to secure the safety of its citizens from all substandard imports. "Country of origin" should be mandatory on every packaging label. Prepared for .......... doesn't tell a consumer anything. I have raised the issue with local politicians here but don't expect a solution any time soon.

Unfortunately it is a case of cheap, cheaper, cheapest without thought to anything else especially quality. I refuse to buy Special K Redberry because the dehydrated strawberries are imported from China. When I contacted Kellogg's they assured me their source was exceptionally clean, etc., etc. Sure it is.
 
Heparin from hog intestines

Heparin from hog intestines

I think I'll skip my next heparin bridge before elective surgery. I guess Lovenox is still OK. but maybe a simple "hold" is the safest. The Washington Post had a detailed article today: FDA CITES PROBLEMS AT CHINESE PLANT MAKING BLOOD THINNER. I never knew heparin could be made from hog intestines.I always thought they got it from snake venom.Wrong, hepar Latin for liver, it was discovered about 1915 by Dr. Jay McLean at Johns Hopkins. He purified it from dog liver. Baxter decided to buy their heparin from ChangzouSPL, located near Shanghai. The factory was supposed to be inspected by the FDA ; however, the FDA approved a different factory with a somewhat similar name but didn't state the product produced there.The FDA apparently never saw the factory in Patty's video. Problems, problems. Congress will try to attack the problem by hiring more overseas inspectors for the beleaguered FDA. Why not make the heparin in Ohio, Indiana, or Michigan where they have lots of hogs and plenty of laid off factory workers? If Baxter is such a great company, couldn't they hire an inspector to check things out? Might save on legal fees!
 
hog farm

hog farm

Marty,

Maybe you should retire and we could open a Heparin only hog farm.;)

As far as a simple hold, I think a monitored reduction would be safer..
 
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