Heparin in Medical Devices Linked to 11 U.S. Deaths

Eleven deaths and 86 cases of harmful side effects this year have been linked to use of medical devices containing the blood thinner heparin, U.S. regulators said.

Most of the cases involved heparin used to clean intravenous lines, said Karen Riley, a Food and Drug Administration spokeswoman, in an interview.

Baxter International Inc. voluntarily recalled its heparin, used to prevent blood clots, beginning in January after reports of side effects. The main ingredient in some of Baxter’s heparin, made in China from pig intestines, was later found to be contaminated.

The heparin associated with two of the 11 deaths wasn’t contaminated, and the FDA can’t say conclusively say how many of the other deaths and side effects involved tainted heparin, according to Riley.

Riley said she also couldn’t identify which companies’ products were associated with the deaths and side effects. In addition to Baxter, companies including the device maker Medtronic Inc. have voluntarily recalled products that may contain contaminated heparin.

The side effects and deaths linked to medical devices occurred between Jan. 1 and May 14, according to the FDA’s Web site.

Since January 2007, 81 people have died after allergic reactions, the FDA said on April 21. Riley said the 11 deaths involving devices are “probably in addition” to the 81, though some of the reports to the FDA are “very sketchy” and there could be “some minor overlap.”

Inaccurate Tests

The FDA also said in a posting on its Web site that contamination could lead to inaccurate test results from diagnostic devices that monitor heparin or use it as part of the device itself.

Baxter hasn’t received reports of deaths associated with its heparin products used to clear intravenous lines, company spokeswoman  Erin Gardiner said in an interview. Reports by doctors and patients can be made to a company or the FDA.

Baxter has said the main ingredient for its heparin probably was contaminated before reaching its supplier in China.

Heparin accounted for about $30 million in annual sales for Deerfield, Ill.-based Baxter, which reported $11.3 billion in revenue last year.

The European Medicines Agency said in a statement that that one of its committees concluded a type of heparin, enoxaparin, can still be used, provided that measures are taken to reduce risks. Enoxaparin was found to include a low level of contamination. Sanofi-Aventis SA’s Lovenox contains enoxaparin.

SOURCE: Bloomberg