FDA sees more Heparin deaths, expands recall

April 09, 2008|By Jonathan D. Rockoff | Jonathan D. Rockoff,Sun reporter

WASHINGTON -- Expanding the scope of its Heparin recall, the government is sending letters to 82 medical device makers today warning them to withdraw any stents, catheters and other products that might contain the contaminated blood thinner.

The move came as the Food and Drug Administration tripled the number of deaths that it said could be linked to the tainted drug. After reviewing more than 1,200 reports of allergic reactions from users, the agency said that 62 deaths since January 2007 may now be related to contaminated Heparin, up from the 19 deaths it previously counted during that period.

In recent years, the FDA has received a handful of reports each month of allergic reactions and low blood pressure from Heparin use.

But the agency saw a "sudden jump" in reports of fatal side effects among those who took the drug from November 2007 through February 2008, said Karen Riley, an agency spokeswoman. For that period, the agency has received 47 reports of deaths.

In warning device makers, the FDA said it wanted to make sure none of their products have Heparin that came from batches of the drug that have since been recalled, said the spokeswoman. Some of the medical devices are coated with the blood thinner to prevent clots in patients, and some tests contain the drug in order to collect unclotted blood for examination.

Baxter International Inc. of Deerfield, Ill., a leading Heparin manufacturer, recalled nearly all its products in February after the first reports of quickening heartbeats, dizziness and other side effects.

The FDA is trying to discover why large quantities of an unapproved chemical were found in tainted supplies of Heparin's main ingredient and whether suppliers in China deliberately added the compound, called over-sulfated chondroitin sulfate.

It is also trying to determine whether the contaminant caused the side effects.

Baxter and its supplier, Scientific Protein Laboratories of Waunakee, Wis., have blamed the contamination on Chinese firms that provided raw Heparin to a manufacturing plant that SPL co-owned in eastern China.

Jonathan.rockoff@baltsun.com

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