Navigation Links
Baxter Recalls Rest of Heparin Products
Date:2/28/2008

Investigation into allergic reactions, deaths related to blood thinner continues

THURSDAY, Feb. 28 (HealthDay News) -- Baxter Healthcare Corp., the pharmaceutical company at the center of recent problems with its blood thinner heparin, announced Thursday that it was recalling any remaining multi-dose vials of the drug as well as single-dose vials.

The company also said it was recalling its Hep-Lock heparin flush products, which contain a small amount of heparin and are used to prevent blood clots in intravenous lines.

The recalls were made possible because the other manufacturer of multi-dose heparin vials -- APP Pharmaceuticals of Schaumburg, Ill. -- was able to assure the U.S. Food and Drug Administration that it could meet the demand for the blood thinner in the United States.

"At the time [in January] when Baxter stopped production of its multi-dose heparin, we determined there would be an immediate and severe shortage of this medically necessary drug," Rear Admiral Dr. Sandra Kweder, deputy director of FDA's Office of New Drugs in the Center for Drug Evaluation and Research, said during an afternoon teleconference Thursday. "Therefore, it was in the interest of the public health to allow multi-dose vials to remain on the market, but to be used with caution."

"Today," Kweder added, "we can report that APP is now able to adequately supply the U.S. market."

As far as Baxter's Hep-Lock products are concerned, there are several manufacturers of similar items, Kweder added.

"We have assurance from the U.S. Food and Drug Administration that there is an adequate supply in the market to meet the demand for these critical and lifesaving drugs," Peter J. Arduini, president of Baxter's Medication Delivery business, said in a statement. "The safety and quality of our products is always our highest priority, and we will continue to collaborate with the FDA as we work to determine the cause of the increased rate of adverse reactions and resolve this issue."

Since the end of December, there have been 448 reports of adverse reactions associated with Baxter's heparin product. This compares with less than 100 reports of adverse reactions in all of 2007.

There have also been reports of 21 deaths, four of which were linked with an adverse reaction to heparin, according to the FDA.

Most of the reactions have taken place at hemodialysis centers, almost exclusively involving patients receiving a "bolus dose," which is a high dose administered over a short period of time, according to the FDA. The drug is also given to patients undergoing heart surgery.

Adverse reactions included difficulty breathing, nausea or vomiting, excessive sweating and falling blood pressure, which can lead to life-threatening shock. These reactions have been seen with as few as several thousand units per milliliter of heparin, and as much as 50,000 units per milliliter.

So far, the source of the problems with heparin has not been identified, Kweder said, adding the investigation is continuing.

The FDA investigation has included a Baxter plant in the United States, as well as a supplier of unrefined heparin to Baxter, Changzhou SPL in Changzhou City, China. The Chinese plant is largely owned by Scientific Protein Labs in Waunakee, Wisc., which is Baxter's main supplier of heparin.

"Our inspection team has finished the inspection of the Chinese facility," Michael Rogers, director of the FDA's Division of Field Investigations in the Office of Regulatory Affairs, said during the teleconference. "The inspection revealed that the facility is currently not manufacturing heparin at this time."

Rogers said the inspection team found "a number of potentially objectionable conditions related to the firm's manufacturing process."

"The inspection team's observations relate to deficiencies in the plant's evaluation of the steps it takes to remove impurities and its investigation of out-of-specification results. Issues related to waste material flow and deficiencies related to equipment," Rogers said.

Rogers noted that while the FDA was concerned about what it found in the Chinese plant, it was not prepared to make a connection between these observations and the adverse events associated with Baxter's heparin.

Inspection of the Chinese plant came after the FDA reported Feb. 19 that it had made a mistake and inspected the wrong Chinese plant, which had a similar name.

More information

For more on heparin, visit the U.S. National Library of Medicine .



SOURCES: Feb. 28, 2008, teleconference with Rear Admiral Sandra Kweder, M.D., deputy director, Office of New Drugs, Center for Drug Evaluation and Research; Michael Rogers, director, Division of Field Investigations, Office of Regulatory Affairs, U.S. Food and Drug Administration, Rockville, Md.


'/>"/>
Copyright©2008 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. Baxter International Third Quarter 2007 Financial Results Conference Call
2. Baxter Reports Strong Third Quarter Sales and Earnings
3. Nektar Announces Agreement With Baxter to Develop New PEGylated Therapeutics for Hemophilia
4. Fairbank Farms Voluntarily Recalls 85% Ground Round Beef Patties Sold Fresh from Shaws Due to Possible Health Risk
5. PriCara(TM) Recalls 25 mcg/hr DURAGESIC(R) (fentanyl transdermal system) CII Pain Patches
6. Manufacturer Halts Production of Blood Thinner Heparin
7. The ScottCare Corporation Completes Acquisition of Rozinn Electronics, a Leading Manufacturer of Cardiac Diagnostic Products
8. Physician Skin Care Specialist Says Proposed New Rules for Sunscreen Products Will Better Protect the Public
9. FDA Seeks to Regulate Complementary and Alternative Medicine; Products Such as Vegetable Juice Could Be Restricted for Medical Use
10. Boston Micromachines Multi-DM Named One of the Years Most Innovative Products
11. Why Are Most Health & Wellness Products Doomed to Failure?
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Baxter Recalls Rest of Heparin Products 
(Date:4/28/2017)... ... April 28, 2017 , ... Woolsy Corporation ... supplements, through its Nova Skin Sciences division, recently announced the launch of Allumière ... with the power of an anti-aging concentrate. , Anogeissus Leiocarpa Bark ...
(Date:4/28/2017)... ... April 28, 2017 , ... Semrock’s highly popular SearchLight ... online modeling resource for fluorescence microscopists and optical system designers, enabling The Right ... years spanning the globe, SearchLight has become a tremendously popular tool for the ...
(Date:4/27/2017)... ... April 27, 2017 , ... The Incentive Research Foundation ... A Nudge Guide," a groundbreaking analysis of how behavioral economics can be applied ... immediately to IRR programs, the report highlights proven behavioral economics approaches and the ...
(Date:4/27/2017)... ... April 27, 2017 , ... The American Brain Foundation ... Leadership in Neurology Award (PLINA). The couple joins a prestigious list of past ... Walter Mondale, actor Michael J. Fox and former U.S. Attorney General Janet Reno. ...
(Date:4/27/2017)... ... ... Goodcents Deli Fresh Subs announced a franchise expansion agreement today including three new ... first new location will open at the corner of 27th and Randolph in Lincoln, ... this fall. And the third location is in the process of being identified. ...
Breaking Medicine News(10 mins):
(Date:4/24/2017)... 24, 2017 Solentim, the developer of ... addition of a major new product line called ... The VIPS has been developed for automatically seeding ... as part of the process to generate clonally-derived ... and more reliable solution when compared to traditional ...
(Date:4/20/2017)... DUBLIN , April 20, 2017 ... the "Global Biosimilar Pipeline and Market Prospects: Addressing ... report to their offering. ... "Global Biosimilar Pipeline and Market ... by Design" provides an in-depth assessment of the current ...
(Date:4/20/2017)... AMSTERDAM , April 20, 2017  AbbVie ... that 99 percent (n=145/146) of chronic hepatitis C ... 4, 5 or 6 and compensated cirrhosis (Child-Pugh ... post-treatment (SVR 12 ) with its investigational, pan-genotypic ... rates were seen following 12 weeks of ...
Breaking Medicine Technology: