Heparin
The New England Journal of Medicine reported that the Centers for Disease Control and Prevention (CDC) in a study titled “Outbreak of Adverse Reactions Associated with Contaminated Heparin,” has confirmed the cause of serious adverse reactions in late 2007 were due to heparin contaminated with oversulfated chondroitin sulfate (OSCS). In the study, the CDC also determined that the contaminated heparin was linked to 152 adverse reactions in 113 patients from 13 states from Nov. 19, 2007 through Jan. 31, 2008.
The study also reported, "the use of heparin manufactured by Baxter Healthcare was the factor most strongly associated with reactions (present in 100 percent of case facilities vs. 4.3 percent of control facilities)." Those facilities included 21 dialysis facilities that reported reactions and 23 facilities that had no reported reactions. Adverse reactions reported included hypotension, Nausea and shortness of breath. Most symptoms presented within 30 minutes of administering the drug.
All of the facilities that reported adverse reactions had vials of heparin manufactured by Baxter Healthcare that were contaminated with OSCS, according to the report. Researchers found that of the 130 reactions for which information on the heparin was available, more than 98 percent occurred in a facility that had OSCS-laced heparin on premises. Of the 54 reactions for which the lot number was known, the report shows that 96.3 percent occurred after the patients received the OSCS-tainted heparin.
According to the report, "Heparin contaminated with OSCS was epidemiologically linked to adverse reactions in this nationwide outbreak. The reported clinical features of many of the cases further support the conclusion that contamination of heparin with OSCS was the cause of the outbreak."
BAXTER LOSES FIRST TRIAL
A Cook County Circuit Court jury recently awarded $625,000 to the estate of a man who was given a dosage of a blood thinner made by Baxter International Inc. that contained a contaminated ingredient found in the company's supply chain in China.
The verdict is the first from a case against Baxter and its supplier, Wisconsin-based Scientific Protein Laboratories, from hundreds of lawsuits filed against the Deerfield-based medical product giant. A mountain of litigation has been leveled against the companies after U.S. regulators determined in 2008 that Baxter's heparin was contaminated, from fake ingredients sourced in China.
The contamination became an international health imbroglio and intensified regulatory oversight of drug makers that have manufacturing plants and supply chains overseas, particularly in China. The exposed definiciencies in Baxter's supply chain led to Congressional hearings and increased oversight of all U.S. drug makers with plants overseas.
Attorneys for the estate of Steven Johansen, 63, of Oak Forest said the man received low doses of contaminated heparin in December 2007 during dialysis at a center in southwest suburban Crestwood. He later received a higher dosage of Baxter's heparin at Palos Community Hospital in Palos Heights where he died on Dec. 13 of that year.
Baxter's popular blood thinner was used widely in large dosages, often before patients have dialysis or heart surgery. A prior trial case brought against Baxter in Cook County was settled earlier this year for an undisclosed amount.
The incident involving Johansen occurred during a period in late 2007 and early 2008 when the U.S. Food and Drug Administration was investigating scores of reports of deaths and injuries from patients who had received heparin, Tribune reports at the time indicate. Baxter subsequently recalled the heparin in early 2008.
The FDA in early 2008 said Baxter heparin tested positive for an animallike substance known as oversulfated chondroitin sulfate. The heparin had been sourced in China where part of the product's manufacturing took place.
"The active pharmaceutical ingredient in the contaminated heparin received by Mr. Johansen and other Americans was obtained from Baxter (and its supplier Scientific Protein Laboratories') Changzhou SPL," Johansen estate attorneys said in a statement. "This crude heparin was referred to in the companies' own internal records as 'the cheap stuff.' The contaminant was determined to be a man-made 'fake heparin' called over-sulfated chondroitin sulfate, causing among other effects, potentially fatal allergic-like reactions."
"Both the Centers for Disease Control and Prevention and FDA identified a well-defined and discrete set of symptoms potentially associated with heparin contamination," Baxter said in its statement. "Baxter will vigorously defend claims that are not consistent with the definition established by public health authorities."
Heparin's active pharmaceutical ingredient was derived from pig intestines from hogs in rural China.
In 2008, Baxter and Scientific Protein Laboratories said they believed a foreign substance was intentionally put in its heparin in the Chinese supply chain. The Chinese government, however, denied the substance was intentionally put into Baxter's heparin. Source: Chicago Tribune
LAWMAKERS EXPAND TAINTED HEPARIN INVESTIGATION
Congress has expanded its investigation of contaminated heparin supplies that were imported from China and given to U.S. patients more than three years ago. Hundreds of lawsuits have been filed as a result of patients being injured or killed after being given contaminated doses of the blood thinner.
Members of the House Energy and Commerce Committee have contacted drug supply companies requiring documents related to the contaminated drugs. This came after information from the Food and Drug Administration indicated that the companies have information related to the Chinese heparin industry and Chinese heparin supply chains. The letter written by the Committee to the companies stated, in part:
There is reason to believe all or some of the individuals responsible for the adulteration are still actively engaged in the Chinese pharmaceutical supply chain and pose a continuing threat to pharmaceutical products imported to the U.S.
The investigation into the cause of the tainted heparin supply began in 2008, when lawmakers asked the FDA to probe the incidents. It's time to require Chinese manufacturers to comply with all requests concerning safety issues.
Source: Lawyers USA Online
