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Chinese Firms at Center of Tainted Heparin Disaster Still Importing to U.S. | cialis online

Chinese Firms at Center of Tainted Heparin Disaster Still Importing to U.S.

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The 2008 Baxter heparin disaster made headlines for months over contaminated ingredients that led to massive recalls and resulted in serious, some fatal, allergic reactions worldwide.

Now, three years later, two companies in China that had supplied the deadly ingredients to Baxter International Inc. are still sending their product to the United States, according to Republican lawmakers, said Bloomberg Businessweek.

When the scandal broke, it was revealed that issues involving contamination by oversulfated chondroitin sulfate was at the root of the deadly problem, which resulted in Baxter International recalling almost all its U.S. heparin injections. Recalls were implemented after patients experienced serious, sometimes deadly, allergic reactions after treatment with the contaminated heparin.

The U.S. Food and Drug Administration (FDA) announced 13 recalls of multiple contaminated medical heparin-containing products from a number of companies. In all, 81 U.S. deaths were linked to the contaminated heparin.

In March 2008, the FDA confirmed oversulfated chondroitin sulfate was discovered in samples of the active ingredient used in the Baxter heparin. According to the FDA, the chondroitin sulfate was molecularly changed to mirror the blood-clotting properties found in heparin; the ingredient was supplied by Changzhou SPL, a Chinese plant owned, in part by Wisconsin-based SPL.

With so many sources involved in the fiasco, the FDA investigation never identified the culprits; however, the agency did reprimand SPL for neglecting to probe complaints about its contaminated product, even after recalls were implemented.

The just-released Republican letter to FDA Commissioner Margaret Hamburg asked why the agency has not warned drugmakers to steer away from Chinese-made products. The group, led by Representative Fred Upton (Michigan), chairman of the House Energy and Commerce Committee, did not name companies, noted Businessweek. “We have reason to believe that these two Chinese firms are still supplying crude heparin that is being imported into the United States,” the lawmakers wrote, reported Businessweek. “We have seen no indication that the FDA has issued warning letters and/or import alerts to these firms even though FDA has issued warning letters and import alerts to other Chinese heparin firms.”

Some 12 million Americans are treated with heparin annually, Businessweek pointed out, citing the letter. The Committee Republicans began their reinvestigation of the heparin debacle this February, expanding the probe in May and seeking information from both the U.S. Immigration and Customs Enforcement and industry leaders in June. “We have very serious public health concerns arising from our investigation,” Upton and four colleagues wrote, said Businessweek.

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