B Braun Recalls Possibly Tainted Heparin

Recall linked back to the 2007/2008 Heparin crisis that poisoned hundreds.

Andrew Zajac from the Los Angeles Times is reporting about the recent announcement by B. Braun Medical Inc., of a recall of seven lots of the anticoagulant heparin because of concerns they may be contaminated with trace amounts of oversulfated chondroitin sulfate, or OSCS, the same substance implicated in the 2008 heparin crisis that killed or seriously sickened dozens of people.

According to the Mr. Zajac’s report:

• The company said in a statement that based on current information, the recalled lots did not pose a significant health risk, but they're being pulled from the market "with the support of the U.S. Food and Drug Administration."

• "There is not a significant public health threat," FDA spokeswoman Karen Riley said.

• The active ingredient in the suspect heparin was manufactured by Scientific Protein Laboratories Inc. of Waunakee, Wis., the same company that supplied the active ingredient for the heparin distributed by Baxter International that poisoned hundreds of patients in late 2007 and early 2008.

• Riley said B. Braun's announcement reflected a decision by Scientific Protein to recall three lots of the heparin ingredient that were distributed to manufacturers in the United States, Canada and Japan. It was not immediately clear how many, if any, other manufacturers are affected by the recall.

• Both the heparin in the poisonings and in the B. Braun recall were manufactured with raw material – pig intestines – from China. An FDA-led inquiry at the time of the heparin crisis identified OSCS as the contaminant. The substance apparently was added in an effort to stretch heparin, which is subject to significant fluctuations in supply because of changes in the Chinese pig population.

• The FDA has not identified who was responsible for the adulteration, or where in the lengthy Chinese supply chain it occurred. The heparin in the B. Braun recall also is from the same batch discussed in a recent FDA inspection that found that Scientific Protein waited a year to investigate a complaint about possible OSCS contamination.

• Riley said the heparin ingredient was manufactured by Scientific Protein in 2006 and was determined to contain traces of OSCS by one of the company's medical industry customers, which called it to the company's attention in October 2008.

• Scientific Protein's "quality department did not initiate a formal investigation into this complaint until 9/9/09," according to the FDA inspection report. It's not clear whether the complaining customer was B. Braun.

Many of the facts of this incident remain to be seen and or made public. It is anticipated that there will be more voluntary recalls and information over the next several days.

Secure Pharma Chain is puzzled with this recent turn of events given the amount of scrutiny that the 2007/2008 Heparin crisis elicited within the government, industry and consumers world wide. It would appear that not all the bases were covered within the supply chain following the deaths of some many back in 2007/2008.

Secure Pharma Chain encourages all within the supply chain to avoid the issues of fraudulent, adulterated, sub-standard and counterfeit drugs by deploying authentication technologies to verify that their inventories are safe and efficacious.

To read the entire story, visit: http://www.chicagotribune.com/health/la-heb-heparin-recall-braun-20101027,0,2834227.story

To learn more about pharmaceutical authentication technologies, visit: http://www.xstreamsystems.net/.

FDA a Paper Tiger: China and the Heparin Probe

Ed Silverman on July 22nd blogs in Pharmalot about the questions being raised in Congress and within the media of the FDA’s lack of holding Chinese officials accountabile in tracking down the issue of the deadly Heparin issue that killed dozens in the US several years ago.

In this excellent blog post, Mr. Silverman highlights:

· ...how hard is the agency trying to get China to cooperate when problems arise? Not hard enough, according to a congressional probe that reveals the FDA repeatedly asked the Chinese government for help in pursuing an investigation into contaminated heparin, but was “severely hampered” by a lack of cooperation.

· You may recall that contaminated heparin made in China was linked to 81 deaths in 2007 and 2008 and the episode sparked a firestorm of criticism at the FDA for its failure to monitor medicines made there. Since then, the heparin scandal has faded from view, but the congressional probe revives the matter - and portrays the agency as a paper tiger.

· “It is shocking to find out two years after Chinese-made heparin was killing Americans, the Chinese government still has done no investigating to find out why,” Joe Barton, the top Republican on the House Energy and Commerce Committee, tells the Wall Street Journal. He and Mike Burgess, another Texas Republican who is the ranking member on the Subcommittee on Oversight & Investigations, blast the FDA for not pressing the Chinese or acting on info obtained over the past two years . The probe, by the way, comes as FDA commish Margaret Hamburg prepares for her first trip to China.

· An FDA spokeswoman tells the Journal that “there are serious limitations on what the FDA can do to pursue civil and criminal investigations in foreign countries, especially without the cooperation of the foreign government.” In a June 16 letter to the congressmen, the FDA wrote that it was “denied full access” to manufacturers of raw heparin in China.

· Chinese security authorities told a US official in Beijing in June 2008, that China wasn’t investigating the heparin episode as a criminal or administrative matter, he tells the paper.

This excellent blog brings to light the ability of the US government to properly investigate serious issues with quality, adulteration, fraud and counterfeiting with an important trading partner where a significant number consumer and health care products and their raw materials originate.

The lack of regulatory cooperation between nations is a serious concern to all within health care and its consumers.

Given the inability of the regulatory authorities to work together and properly vette and secure the global supply channels. Secure Pharma Chain believes that it is critical for all members of the global pharmaceutical supply chain to take measures to protect its inventories and brand by deploying technologies that validate the authenticity and efficacies of its products.

To read the entire Pharmalot blog, visit: http://www.pharmalot.com/2010/07/china-stymies-fda-probe-into-contaminated-heparin/#more-25075

To learn about supply chain validation solutions, visit: http://www.xstreamsystems.net/.

FDA Investigating Deaths of Heparin Patients

Two patients have died from adverse reactions to heparin at Beebe Medical Center in Delaware. Another patient hospitalized at Beebe is also experiencing the same adverse reaction. The deaths are being investigated by the Food and Drug Administrations (FDA) and Baxter Healthcare, who supplied the blood thinner to facility. It is uncertain what caused the reaction. Unlike last year’s recall in which patients developed low blood pressure, these patients developed intracranial bleeding.

Baxter stated that the active ingredient in the product was obtained from Pfizer and not bulk suppliers in China. Pfizer commented that while they do source heparin raw materials from China, they believe that the lot number in question was purchased domestically.

This reaction seems to be an isolated case and has not been reported as any other facilities.

The Delaware hospital where both patients died emphasized that it's not sure heparin caused the deaths. "We are not pointing fingers at Baxter," a Beebe Medical Center spokesman stated. "We don't know what's going on, but heparin is the only commonality that we were able to see ourselves."

Baxter CEO Says Heparin Purposely Tainted

Yesterday on Capitol Hill, a house subcommittee heard testimony on the recent issue of contaminated Heparin. Robert Parkinson, CEO of Baxter testified that the company believes the heparin was deliberately tainted.

Most heart wrenching, was when the family’s victims told their stories on how the tainted Heparin has destroyed their lives.

Leroy Hubely, was in tears as he explained how his wife Bonney died in December 2007 and then a month later his son, Randy died under the same circumstances. Only after the recall of Heparin, did he learn from his local dialysis center that tainted heparin, and not some cruel twist of fate, led to both of their deaths.

His daughter-in-law Collen Hubely, a dialysis nurse, testified: “As a nurse, I thought that I would be there to save my husband from any errors, but I guess I was naive. I never thought the life saving medication we were relying on might be contaminated. If citizens are truly going to ever to feel safe in this country going to the hospital, a doctor, taking your daily medication; we have a responsibility to be make sure that everything that is given is free from contamination.”

Families demanded more stringent policies and testing to protect consumers from dangerous materials hidden in our medications.

FDA Links 100 Deaths to Heparin Since 2007

Late yesterday, the FDA announced publicly that over 100 patients within the United States have died while taking the blood thinning medication Heparin since January 2007.

The FDA found that over 62 of the deaths are the result of allergic reactions to contaminated batches of Heparin, which is significantly higher than their previous estimate of 19 deaths. Many of these deaths were not reported when they occurred, but are only now being reported to the FDA.

Allergic reactions to heparin are rare with only 3 deaths reported in 2006. However these increased in 2007, jumping dramatically to 8 in November, 12 in December, 16 in January, and 11 in February. FDA has posted the month to month mortality statistics on their website.

The presumed cause of the increased reactions is the adulterated compound the FDA discovered in the recalled products, whose ingredients were imported from China (See: Chemically Altered Chondroitin-Sulfate Found in Recalled Heparin).

China is a major supplier of raw heparin, which is derived from pig intestines. Recent decreases in swine population, due to blue ear disease, have caused Chinese plants to turn to smaller wholesalers for their own supply. Chondroitin-Sulfate is less expensive than its genuine heparin counterpart, which may explain why it was incorporated in the raw heparin.

In answer to this major threat, recalls have expanded to seven countries: U.S., Germany, Japan, Denmark, France, Italy, and Australia. Furthermore, the FDA has upgraded the pharmaceutical testing of imported Heparin.