Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

The sole provider of heparin in the United States, APP Pharmaceuticals LLC, has launched a Web site as a first step toward improving the safety of the medications it sells in the U.S., according to Reuters.

The Web site details the safety measures the pharmaceutical company has taken over the past several months, including enhanced labeling, unit-of-use bar codes, large lettering and color-coded bottle stoppers to help eliminate misuse of its products, which also includes injectible drugs for oncology.

APP Pharmaceuticals became the only U.S. provider of the blood thinner heparin after batches of heparin manufactured at Baxter International’s Chinese plant were found to have been contaminated. The tainted heparin killed more than 80 Americans and sickened hundreds more before the FDA pinpointed the source of contamination and issued a recall of the specific lots.

APP Pharmaceuticals has two U.S. manufacturing plants and one in Puerto Rico, however it imports its raw material from a Chinese supplier.

Heparin also was thrust into the spotlight in 2007 with the much-publicized overdosing of actor Dennis Quaid’s newborn twins. The newborns nearly died after they were accidentally given 1,000 times the intended dose. Other cases of heparin overdose have been reported and linked in part to similar packaging of high-dose and low-dose heparin.

APP Pharmaceuticals‘ safety initiative comes on the heels of new federal requirements for health care facilities that go into effect January 1, requiring health care facilities to have in place a comprehensive anticoagulation management plan in order to be accredited by the U.S. Joint Commission.

This entry was posted on Tuesday, December 9th, 2008 at 8:38 am and is filed under Heparin recall, News. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.