Saturday, January 26, 2008

Check Your Heparin

Two different recalls of heparin contamination were just released:

One from Baxter Pharmaceuticals:
(WSJ) The Deerfield, Ill., company began recalling the lots on Jan. 17. Baxter said it normally receives 60 to 70 reports during a given year of possible reactions to heparin, but in this instance it received about 150 such reports just so far in January, the company said Friday. The reactions include a range of symptoms, such as nausea, vomiting, dizziness, fainting, throat swelling and low blood pressure.

The company said that so far one death has occurred that "may be associated" with the heparin in question.

The units in question are called "1,000 units/mL 10mL and 30mL multi-dose vials." Baxter said it hasn't seen an increase in adverse reactions to any of its other forms of heparin.
The other recall comes pre-filled syringes from AM2 PAT, Inc., of Angier, N.C.:
(via the FDA) Two lots have been found to be contaminated with Serratia marcescens, a bacterium that can cause serious injury or death.

These syringes are manufactured by AM2 PAT under the brand names Sierra Pre-filled, Inc. and B. Braun. They are sold in fill sizes of 3mL, 5mL and 10mL and syringe sizes of 6mL and 12mL.

Consumers and health care facilities with any of the recalled, pre-filled Heparin Lock or Normal Saline IV Flush syringes should stop using the product immediately. Health care facilities should immediately quarantine the products in their inventory and return them to their distributor. Individual consumers should return them to the location from which they were received, such as a pharmacy or hospital. They should also let their health care providers know that they have been exposed to syringes recalled by FDA.

The recall affects all lots of these products. The FDA received information that Heparin Lock Flush syringes from Lot 070926H and Normal Saline IV syringes from Lot 070917A have been found to be contaminated with Serratia marcescens, and have resulted in patient infections. The U.S. Centers for Disease Control and Prevention has confirmed growth of Serratia marcescens from unopened heparin syringes.

Traditionally, Serratia marcescens, a bacterium found in water and soil has been linked to pneumonia, blood infections, and urinary tract and wound infections. Some patients exposed to the recalled syringes have developed blood infections.
Weird how these came a day apart. But don't worry, the lawyers are already on it.


References: Baxter's recall notice.

AM2 PAT's press release.

1 comment:

SeaSpray said...

Dr one of the uses for this product to give this to post-op pts to help prevent blood clots?

Are all hospitals automatically on top of these recalls so that pts health/safety isn't compromised?

I vaguely remember something the Happy Hospitalist wrote where studies indicate a certain preventative procedure post -op was now in question.

Apples and oranges I know, because you are talking about contamination
and I think he was talking about the use of a certain drug. Maybe it wasn't Heparin and I will have to go back over his posts.

Informative post.