FDA Triples Tally Of Heparin-Linked Deaths

More Than 100 Patients Taking Blood Thinner Died In 2007; Role Of Contamination Unclear

(AP)  The Food and Drug Administration has tripled the number of deaths it attributes to side effects of the blood thinner heparin, which triggered a massive recall earlier this year.

The agency has been investigating contamination of heparin made by the manufacturer Baxter International Inc., which it linked to 19 deaths and hundreds of allergic reactions.

After reviewing adverse events back to January 2007, FDA said Tuesday it uncovered 103 reports of patients who died while taking heparin.

Of those deaths, 62 involved allergic reactions or hypotension, a type of dangerously low blood pressure. Those are the same side effects that caused Baxter's to pull all U.S. heparin injections from the market by February.

The agency's month-by-month figures include deaths of patients taking heparin made by various manufacturers, not just Baxter's.

FDA received 55 reports of death with the blood thinner in 2006, but only three were due to allergic reactions.

FDA spokeswoman Karen Riley said the agency decided to release the additional numbers on heparin deaths at the request of consumers. Previous agency announcements were limited to adverse events recorded in 2008.

Riley said the drug has long carried warnings of low blood pressure risks, which likely contributed to deaths seen in prior years.

A Baxter spokeswoman said the Deerfield, Ill.-based company has identified only four deaths to date where its recalled heparin may have played a role. FDA's numbers include reports from additional sources, including other manufacturers.

Another manufacturer, APP Pharmaceuticals Inc., said there have been no reports of death with its product due to the allergic reactions cited by FDA. The agency found no contamination in heparin batches made by the Schaumburg, Ill.-based company.

Heparin is derived from a mucous obtained from pig intestines and other animal tissues, often processed by small, unregistered workshops in China.

FDA determined last month that Baxter's drug was contaminated with an unnatural chemical during production at a plant in China. The agency is still investigating whether the chemical was added accidentally or deliberately.

Shares of Baxter International Inc. fell 61 cents, or 1 percent, Tuesday to close at $59.83. Shares of APP Pharmaceuticals Inc. rose 6 cents to close at $13.

[rf35]

This looks like business as usual between Big Pharma and the FDA. This side effect problem from synthetic drugs keeps keeping on.
Posted by Baileycc

Thing is, Heparin is derived from animal mucous, a natural item. Allergic reactions are much more likely from natural substances than synthetics. Since Heparin is mostly used in emergency situations, there is no time to test a patient for a reaction before administering the full dose. Of course, that still leaves 41 deaths to account for.

[greeneyes222]

When there was talk of importing prescription medicines from Canada because they were less expensive, the FDA said it was dangerous and fought the idea.

Now we learn that our "much safer" medicines are being manufactured in China with next to no oversight from the FDA, that there is massive contamination, and that apparently no one at the FDA can count highher than their 10 fingers and 10 toes when it comes to the number of deaths.

One would have to love the irony of it all if the situation weren''t so serious. What in Hades is the FDA doing these days? and how many people have to die over it?

[timdgrim]

The American Public: Guinea Pigs of Big Pharmaceutical Companies...Squeal! Squeal!

[brianbwb-2009]

Injecting chitlin'' snot cannot be a good thing. I remember becoming nauseous at the smell of boiling "chitterlings", and to this day still cannot take that smell, I could even sense it subtly infused in pork chops, and ham. I stopped eating pork as a teenager, and to date haven''t touched it. It doesn''t surprise that people can die putting extract of pig mucus into their blood.

[simpleguy234]

so.....a drug kills a hundred and the maker can be sued.......an administration kills thousands upon thousands but its ok..........hmmmm...where is the common sense here..there is none....we Americans are really *** stupid

[john1082]

OOPS doesn''t count

This looks like business as usual between Big Pharma and the FDA. This side effect problem from synthetic drugs keeps keeping on.

[alphaa10-2009]

In other words, had the public and press not been alerted about known heparin deaths, the FDA might never have gone public-- or tripled its own estimates of heparin mortality from all causes.

This is a very bad year to be a GOP bozo at the FDA, particularly one with a political appointment. Year-round damage control has become the watchword, as both health practicioners and drug manufacturers report embarrassing oversights and industry-friendly but patient-hostile FDA practices.