Personal Injury Law

More Deaths Reported as Baxter Expands Heparin Recall

By Jane Akre

The FDA reports additional patient deaths are possibly linked to the blood thinner heparin so the company is mounting a recall of all of the drug.  

Baxter International Inc. will recall the remaining lots of single and multi-dose injection and it will recall HEP-LOCK products.

Last month, Baxter recalled nine lots of heparin multi-dose after the drug's use was linked to four deaths and hundreds of mysterious allergic reactions.

Most of those adverse events were attributed to the multi-dose vial of heparin.

Now 17 other deaths are being investigated because of a link to heparin, although the FDA reminds reporters that those patients were already very sick so a definitive cause-effect at this time has not been established.

The active ingredient in heparin is made from membranes of pig intestines supplied by a Chinese plant,Changzhou SPL, co-owned by a Wisconsin company, Scientific Protein Laboratories of Waunakee.

The FDA has finally completed its investigation of the facility after initially confusing the plant's name with another that had been inspected while it had not.

In a heavily redacted report released Thursday, the FDA said the facility had overall quality control and problems with its equipment and cleanliness.    And there is some question about the source of pigs that are slaughtered at nearby Chinese village farms.

The FDA on its web site says some of the ingredients came "from an unacceptable workshop vendor" but has not sourced the "root cause" of the problems linked to Baxter's heparin.

The last step of heparin manufacturing occurs at the company's Cherry Hill, New Jersey facility, which has been okayed by the FDA.

Heparin is commonly used in emergency rooms and dialysis centers as a blood thinner to avoid clots. It is the same drug that was given in an accidental overdose to the newborn twins of actor Dennis Quaid. He and his wife are suing Baxter because the vials of the low dose and high dose heparin have a similar blue label which had led to confusion and deaths before the Quaid incident. 

Baxter is the largest maker of heparin. Still on the market is a premixed IV solution that does not come from China. U.S. supplies of heparin are said to be sufficient.

Heparin brought Bayer about $30 million in sales in 2007.  #

Full post as published by InjuryBoard on February 29, 2008 (boomark / email).