FDA says Germany recalls blood-thinner heparin
WASHINGTON (Reuters) - Germany has recalled supplies of the blood thinner heparin following reports of severe reactions, expanding a withdrawal of the drug linked to 19 U.S. deaths, the Food and Drug Administration said on Thursday.
The recall brings into question the safety of European supplies of the drug, which become the target of a U.S. investigation after a spike in fatalities and severe reactions in some patients taking heparin sold by Baxter International Inc.
"What is significant about the German recall is that the heparin active ingredient in their product was not obtained from SPL," or Scientific Protein Labs, Baxter's supplier, FDA Deputy Commissioner Janet Woodcock said.
"We're concerned about worldwide, this contaminant, in heparin and making sure it is safe, (and) out of the heparin supply," Woodcock said.
German authorities do not expect a shortage of the drug, FDA said.
The FDA began probing Baxter's heparin several weeks ago after it was linked with to four deaths and hundreds of severe reactions, such as breathing problems and rapid drops in blood pressure. On Wednesday it said it identified a contaminant that may be linked with the drug's problems.
Some 19 fatalities have now been associated with use of the drug in the United States, the FDA said on Wednesday. However, all the deaths have not been linked to a specific drug maker.
The other major U.S. heparin supplier, APP Pharmaceuticals Inc, has ramped up production to avoid a drug shortage. Tests on APP's heparin have not found any contamination, Woodcock said on Wednesday.
No fatalities were seen in Germany, and "less than 100" severe reactions led to the recall, the FDA said. The German product manufacturer, Rotexmedica GmbH, could not be immediately reached for comment.
Heparin is derived from pig intestines. It is used in dialysis and heart procedures, among other surgeries, to avoid blood clots.
FDA officials also advised companies and countries to begin using a sophisticated testing technique the agency used to find the potential contaminant, to test all heparin on the market.
"With this testing method, there will be a way to protect the heparin supply," Woodcock said.
FOREIGN INSPECTIONS
Baxter's main supplier is Wisconsin-based Scientific Protein Laboratories LLC (SPL), which has a major facility in China, a main subject of FDA's investigation.
About 80 percent of the active pharmaceutical ingredients come from foreign sources, according to U.S. government investigators. Most of the world's heparin supply is from China, according to Baxter.
The FDA inspects only about 7 percent of foreign manufacturing facilities annually, according to the Government Accountability Office, a congressional watchdog agency.
China's reputation has been tainted after health scares with pigs and massive recalls of pet food and children's toys containing lead paint.
Sidney Wolfe, head of health research at the consumer group Public Citizen, said the FDA has poorly allocated its resources for inspections.
"China has a tiny fraction of plants being inspected as opposed to India, which is dangerous considering that China is a country far less advanced," Wolfe said.
The FDA conducted about 13 inspections at Chinese plants in 2007, versus 65 at plants in India. China has 714 facilities against India's 410, according to the GAO report.
Baxter has recalled most of its U.S. supplies of the drug. It sells the product in other European countries but not in Germany.
But Baxter does not sell the specific vial-based product linked to the four U.S. deaths in European markets, company spokeswoman Erin Gardiner said.
(Additional reporting by Lisa Richwine; editing by Leslie Gevirtz/Andre Grenon)
