Rest of Sanofi's contaminated Lovenox recalled

The heparin saga continues...

PARIS, Sept 23 (Reuters) - French drugmaker Sanofi-Aventis (SASY.PA: Quote, Profile, Research, Stock Buzz) has recalled remaining batches of contaminated blood thinner Lovenox, a heparin, which were distributed before May 2008, French drug regulator Afssaps said.

Earlier this year, high levels of contamination with an oversulphated chondroitin sulphate in different types of heparin -- derived from pig intestines and used to prevent and treat blood clots -- were linked with serious side effects and deaths.

No such side effects were observed with Sanofi's Lovenox and the European Medicines Agency said in June doctors in Europe could continue to use the drug despite low levels of contamination found in some batches of the product.

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Heparin taint tied to deaths

FDA: 3 fatalities linked to material in Baxter product

The U.S. Food and Drug Administration, for the first time, has conclusively linked deaths of patients infused with the blood thinner heparin to a foreign substance found in specific lots of the drug made by Deerfield-based Baxter International Inc.

In an interview Tuesday with the Tribune, the FDA said it completed its review of 93 death reports related to heparin that the agency received from Jan. 1 to March 31, a period when there was a dramatic spike in potentially deadly allergic reactions from patients who had been injected with heparin. The popular blood thinner is used widely in large dosages, often before patients have dialysis or heart surgery.

Of 10 reports of death from severe shock known as anaphylaxis or hypotension, three of those could be traced to lot numbers of Baxter products that tested positive for an animallike substance known as oversulfated chondroitin sulfate. Heparin lot numbers were not known for the other seven deaths from anaphylaxis or hypotension, so the FDA could not determine whether those 7 patients received heparin contaminated with the substance.

"We have what looks like a cause and effect in some patients," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in an interview, referring to the three deaths linked to contaminated heparin. "We know that they got contaminated heparin, and they died subsequently. This is one of the final links in the chain."

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Heparin Recall Update

The Chinese delegation visited the Baxter site in Cherry Hill last week...and there hasn't been much follow-up in the press...

It was heard that that the Chinese requested samples of the product in question in order that they can do their own testing in China...and that these samples were provided to them...

Anybody want to guess what the Chinese will report?

At an embassy news conference in Washington, Chinese officials said the problems
linked to heparin could have occurred in the United States, or that chronic
conditions in some patients led to severe reactions.

This is not the statement of a scientific team focussed on identifying the root cause of an adverse event...which is a demanding, difficult task which requires good research, scientific judgement and caution...these things need to be right...

No, this is the type of waffling statement made by organizations trying to duck out on their responsibility...they will say anything in order to shift the blame or to avoid being held accountable...exactly the sort of behavior that can not possibly result in identifying and correcting the current problem...

More on the Heparin Saga

Chinese quality stinks!!! Chinese drug regulation stinks!!!

"urging"...

"issued a plea"...

"safeguarding the legality, quality and safety of active pharmaceutical
ingredients (APIs)" is ultimately the responsibility of the importing
country."

These people are unbelievable...

China's drug regulatory authority is finally responding to curb its damaged reputation by urging its local authorities to take a more proactive role in stemming what is fast becoming a global heparin contamination, sparked by material sourced in the country.

According to Chinese media reports, the State Food and Drug Administration (SFDA) issued a message on its website urging its regional offices to boost their supervision of the production methods of heparin manufacturers in their locality.

The watchdog has also urged heparin producers to source their raw heparin from registered suppliers only, and issued a plea to heparin manufacturers to ensure they are producing the material in accordance with the approved standards.

In addition, the SFDA warned manufacturers that they must take the initiative to closely follow the clinical effects of their products that are on the market and if any problems are linked back to their manufacturing facilities, they must halt production immediately and recall any implicated products from the market.

Moreover, the agency told raw heparin suppliers to tighten their management and quality checks of raw and supplementary materials. The SFDA's latest actions indicate a softening of the stance on drug exports from the country that it took this time a month ago, when it effectively sent out a message to the world of "buyer beware".

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FDA Product Safety Alert for Heparin

the Heparin saga continues...

Braun Heparin Sodium in 5% Dextrose and 0.9% Sodium Chloride Injection Solution

The Heparin Saga expands...

B. Braun Medical issues recall of heparin

B. Braun Medical Inc. recalled heparin blood thinner in the U.S. and Canada after learning that it contained a "heparin-like contaminant" from a supplier linked to deaths and allergic reactions in another company's product.

The contaminant was supplied by Scientific Protein Laboratories, Irvine-based B. Braun Medical said Friday. Scientific Protein also supplied Baxter International Inc. with heparin containing a cheaper ingredient from China.

Baxter's heparin has been linked to serious allergic reactions and 19 U.S. deaths. The heparin recalled by Braun is sold to hospitals as a premixed solution in intravenous drip bags, a Food and Drug Administration spokeswoman said.

Neither Braun nor the FDA was aware of anyone sickened by the recalled heparin.

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