Navigation Links
Mix-Up Behind FDA's Failure to Inspect China Blood-Thinner Plant
Date:2/18/2008

Agency error means facility linked to fatal lots of injected heparin was ignored, officials say

MONDAY, Feb. 18 (HealthDay News) -- Due to a name mix-up, the U.S. Food and Drug Administration (FDA) failed to inspect a Chinese plant that made the active ingredient in vials of heparin now linked to four U.S. deaths, the agency said in a Monday press conference.

The vials of multi-dose injectable heparin -- suspended from the market earlier this month by the manufacturer, Baxter Healthcare Corp. -- may have caused severe allergic reactions in American patients, four of which proved fatal.

Generally, the FDA inspects all foreign plants that make pharmaceuticals imported into the United States.

However, "when this site was named in the application [by Baxter], the firm selected and sent to the office of compliance for evaluation was not the correct firm. It was another firm with a similar name. We therefore evaluated the firm, with a similar name. Therefore, this particular firm was not put forward for evaluation," said Joseph Famulare, deputy director of FDA's Office of Compliance.

"We have discovered that; we are acting on that by doing our immediate inspection," Famulare said. "Today, this is isolated situation, but the wrong firm was put in to the database. Therefore, this one was not evaluated or scheduled for inspection," he said.

The agency is continuing its investigation into the source of the error, officials said.

A spokesman for China's State Food and Drug Administration told The New York Times on Friday that the FDA-inspected plant was not a drug manufacturer but "a producer of chemical ingredients" and not licensed to make pharmaceutical products.

Michael Rogers, director of FDA's Division of Field Investigations in the Office of Regulatory Affairs, is spearheading the investigation. He told reporters that the agency is uncertain as to what is causing the adverse events linked to use of the injected heparin.

The FDA has an ongoing inspection at Baxter's plant in Cherry Hill, N.J., and at Baxter's supplier, Scientific Protein Labs in Waunakee, Wisc, Rogers said during Monday's teleconference. Starting this week, the FDA also begins investigating the correct plant in China, which makes the active pharmaceutical ingredient in heparin, he said.

"The inspection team will be conducting good manufacturing practicing inspection at the Chinese facility," Rogers said. "The inspection is designed to determine if the Chinese firm is in compliance with FDA regulations. We'll also be focusing on the firm's manufacturing process and how it adheres to the drug applications," he said.

Since the end of December, there have been about 350 reports of adverse reactions associated with Baxter's heparin product. This compares with less than 100 reports of adverse reactions in all of 2007.

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.

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.

It's not clear how long Baxter's production of injectable heparin will be stopped. The one thing that is clear is that the stoppage could lead to a shortage of heparin, which is used to prevent blood clots in such patients as those undergoing kidney dialysis and heart surgery, U.S. health officials said.

More information

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



SOURCES: Feb. 18, 2008, teleconference with: Michael Rogers, director, Division of Field Investigations, Office of Regulatory Affairs; Joseph Famulare, deputy director, Office of Compliance, U.S. Food and Drug Administration; The New York Times


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

Related medicine news :

1. High and mighty: first common height gene identified by researchers behind obesity gene finding
2. Lung Cancer Alliance Stands Behind CT Screening for Lung Cancer
3. The science behind the food we eat and the earth on which it grows
4. Plastic Surgery 2007: Where Truth Behind Emerging Cosmetic Treatments Meets Amazing Reconstructive Advances
5. Second pathway behind HIV-associated immune system dysfunction identified
6. Nationally Recognized Corporations and Retailers Rally Behind breastcancer.org
7. P&G Reports EPS of $0.92, Up 16% Behind 8% Sales Growth
8. Researchers chart the genetic mechanisms behind the genesis of fat cells
9. NCPA President Steve Girouxs Testimony at FDA Behind the Counter Hearing
10. Theres More Than Turkey Behind Holiday Yawns
11. Researchers led by Penn vet uncover the delicate protein balance behind the immune system response
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Mix-Up Behind FDA's Failure to Inspect China Blood-Thinner Plant 
(Date:5/26/2016)... ... May 26, 2016 , ... Intalere, the healthcare industry ... for its inaugural Member Conference at the Paris Hotel in Las Vegas, Nev., ... health of America’s healthcare providers. , The conference was highlighted by the announcement ...
(Date:5/26/2016)... ... ... On Memorial Day, Hope For Heroes and USA Medical Card will ... country. The nonprofit Hope For Heroes partnered with the leading provider of free ... military veterans, as well as police, firemen, and EMS professionals across the country, and ...
(Date:5/26/2016)... ... ... There are nearly 14.5 million people living with and beyond cancer in ... 5, 2016, communities around the world will gather to recognize these cancer survivors as ... Day® is an annual worldwide Celebration of Life that is held on the first ...
(Date:5/26/2016)... ... May 26, 2016 , ... Dr. James Maisel will present ... Island Chapter on June 4, 2016, 1:30-3:30 pm at the Farmingdale Public Library. ... Retina Group of New York , is a Board Certified ophthalmologist who completed ...
(Date:5/26/2016)... ... May 26, 2016 , ... Memorial Day Weekend marks ... Amica Insurance is sharing tips to make sure your family and vehicle are ... National Safety Council, there may be 439 deaths and an additional 50,500 serious injuries ...
Breaking Medicine News(10 mins):
(Date:5/27/2016)... The healthcare sector is large ... all falling under its umbrella.  A rather overlooked sector ... talked about, these healthcare companies are still trying to ... is by far the largest consumer of the healthcare ... ADMD), Nutranomics Inc. (OTC: NNRX), KollagenX Corp. (OTCQB: KGNX), ...
(Date:5/26/2016)... 26, 2016 A key trend ... the emergence of new treatments. Cardax, a development stage ... treatment. The therapy is expected to fulfil large unmet ... is conducting studies to develop new treatments for osteoarthritis. ... genes involved in osteoarthritis are being investigated, and early ...
(Date:5/26/2016)... NASHVILLE, Tenn. , May 26, 2016 ... provider of software and analytics, network solutions ... healthcare, today announced it entered into a ... leading provider of outpatient software solutions and ... surgery centers, specialty hospitals and rehabilitation clinics ...
Breaking Medicine Technology: