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By Jonathan D. Rockoff and Jonathan D. Rockoff,Sun reporter | April 9, 2008
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.
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NEWS
May 22, 2008
Americans will gain important protections from life-threatening contamination of food and drugs once federal regulators are given an extra $275 million to inspect imported products abroad to ensure they are safe. Last week, the Senate Appropriations Committee approved legislation that would provide the money in a bill intended to fund the war in Iraq. Congress and President Bush should confirm that prudent action. Otherwise, consumers will lack adequate safeguards from potentially unsafe foreign products for at least another year.
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NEWS
By Jonathan D. Rockoff and Jonathan D. Rockoff,Sun reporter | March 22, 2008
WASHINGTON -- A second American company recalled Heparin products yesterday as China announced that it was clamping down on production of the blood-thinning drug's main ingredient to prevent further cases of contamination. B. Braun Medical Inc. withdrew 23 lots of Heparin products after learning that it had received a contaminated ingredient. The Bethlehem, Pa., company described the recall as precautionary. It said it had not received any reports of side effects, even though the suspect lots have been sold in the United States and Canada.
NEWS
By Jonathan D. Rockoff and Jonathan D. Rockoff,Sun reporter | May 15, 2008
WASHINGTON -- Efforts to make the blood thinner heparin safer - and to replace supplies that were depleted by a major recall this year - have meant unintended and fresh safety concerns for hospitals, heart clinics and dialysis centers that use it. The drug, a staple of medical care prescribed tens of millions of times a year, was recalled in February after contamination during production in China led to as many as 81 deaths in the United States....
NEWS
By JONATHAN D. ROCKOFF AND RICARDO ALONSO- ZALDIVAR and JONATHAN D. ROCKOFF AND RICARDO ALONSO- ZALDIVAR,SUN REPORTER | April 22, 2008
WASHINGTON --A contaminated blood thinner from China suspected in dozens of U.S. deaths has now become a worldwide public health problem, with 10 other countries detecting the often-toxic ingredient, federal investigators said yesterday. The compound, which in tests mimics the real blood thinner heparin but costs less to make, may have been added deliberately somewhere along a production chain that began on farms in China, beyond the reach of U.S. regulators. Food and Drug Administration officials also announced a major scientific breakthrough in their attempt to understand how patients got sick from the contaminated heparin.
NEWS
By Jonathan D. Rockoff and Jonathan D. Rockoff,Sun reporter | March 6, 2008
WASHINGTON -- Renewing fears about unsafe Chinese products, investigators probing deaths linked to a popular blood thinner are trying to determine whether the drug was deliberately contaminated in China with a fake ingredient. Testing of the suspect Heparin products revealed significant quantities of a chemical that looks like the key ingredient in the drug and apparently substituted for it, federal drug regulators said yesterday. All of the ingredient came from China, the drug's maker said.
NEWS
By Jonathan D. Rockoff and Jonathan D. Rockoff,Sun reporter | March 20, 2008
WASHINGTON -- Investigators have moved closer to understanding how a widely used blood thinner killed as many as 19 Americans, identifying the chemical that tainted the Heparin products. Meanwhile, the American companies that made Heparin and its main ingredient blamed suppliers from China for the contamination. The Food and Drug Administration said yesterday that the chemical was a kind of souped-up version of a compound commonly used to treat arthritic joints. The chemical - over-sulfated chondroitin sulfate - is not approved for use in prescription drugs sold in the United States, and it doesn't normally figure in the production of Heparin, FDA officials said.
NEWS
By Jonathan D. Rockoff and Jonathan D. Rockoff,Sun reporter | May 15, 2008
WASHINGTON -- Efforts to make the blood thinner heparin safer - and to replace supplies that were depleted by a major recall this year - have meant unintended and fresh safety concerns for hospitals, heart clinics and dialysis centers that use it. The drug, a staple of medical care prescribed tens of millions of times a year, was recalled in February after contamination during production in China led to as many as 81 deaths in the United States....
NEWS
By Jonathan D. Rockoff and Jonathan D. Rockoff,Sun Reporter | March 13, 2008
WASHINGTON -- On Jan. 4, Dr. Alexis M. Elward, a troubleshooter at St. Louis Children's Hospital, was summoned to investigate severe allergic reactions in two children undergoing dialysis there. Elward -- an Annapolis native trained in Maryland -- quickly mobilized a team of investigators and alerted authorities, the start of an international probe into contamination of the blood thinner Heparin. The government's publication of her alert triggered an outpouring of similar reports, which resulted in a major recall of the popular drug last month.
NEWS
By Claire Panosian Dunavan | May 9, 2008
Not long ago, the global crisis in tainted and counterfeit drugs hit home for me. My cousin Laura - high-octane teacher, wife and mom - was rushed to her local emergency room. Six weeks earlier, she had had surgery for a broken tibia and fibula. Now a vein in her leg had clotted, and she needed immediate, high-dose anticoagulation. Physically and psychologically, Laura's first hospital stay had been bad enough. Unfortunately, after the surgery, no one had told her to stop taking her birth control pills because of the risk of clotting.
NEWS
By Claire Panosian Dunavan | May 9, 2008
Not long ago, the global crisis in tainted and counterfeit drugs hit home for me. My cousin Laura - high-octane teacher, wife and mom - was rushed to her local emergency room. Six weeks earlier, she had had surgery for a broken tibia and fibula. Now a vein in her leg had clotted, and she needed immediate, high-dose anticoagulation. Physically and psychologically, Laura's first hospital stay had been bad enough. Unfortunately, after the surgery, no one had told her to stop taking her birth control pills because of the risk of clotting.
NEWS
By JONATHAN D. ROCKOFF AND RICARDO ALONSO- ZALDIVAR and JONATHAN D. ROCKOFF AND RICARDO ALONSO- ZALDIVAR,SUN REPORTER | April 22, 2008
WASHINGTON --A contaminated blood thinner from China suspected in dozens of U.S. deaths has now become a worldwide public health problem, with 10 other countries detecting the often-toxic ingredient, federal investigators said yesterday. The compound, which in tests mimics the real blood thinner heparin but costs less to make, may have been added deliberately somewhere along a production chain that began on farms in China, beyond the reach of U.S. regulators. Food and Drug Administration officials also announced a major scientific breakthrough in their attempt to understand how patients got sick from the contaminated heparin.
NEWS
By Jonathan D. Rockoff and Jonathan D. Rockoff,Sun reporter | April 9, 2008
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.
NEWS
By Jonathan D. Rockoff and Jonathan D. Rockoff,Sun reporter | March 22, 2008
WASHINGTON -- A second American company recalled Heparin products yesterday as China announced that it was clamping down on production of the blood-thinning drug's main ingredient to prevent further cases of contamination. B. Braun Medical Inc. withdrew 23 lots of Heparin products after learning that it had received a contaminated ingredient. The Bethlehem, Pa., company described the recall as precautionary. It said it had not received any reports of side effects, even though the suspect lots have been sold in the United States and Canada.
NEWS
By Jonathan D. Rockoff and Jonathan D. Rockoff,Sun reporter | March 20, 2008
WASHINGTON -- Investigators have moved closer to understanding how a widely used blood thinner killed as many as 19 Americans, identifying the chemical that tainted the Heparin products. Meanwhile, the American companies that made Heparin and its main ingredient blamed suppliers from China for the contamination. The Food and Drug Administration said yesterday that the chemical was a kind of souped-up version of a compound commonly used to treat arthritic joints. The chemical - over-sulfated chondroitin sulfate - is not approved for use in prescription drugs sold in the United States, and it doesn't normally figure in the production of Heparin, FDA officials said.
NEWS
By Jonathan D. Rockoff and Jonathan D. Rockoff,Sun reporter | March 15, 2008
WASHINGTON -- The government is ratcheting up testing of the blood thinner Heparin and its main ingredient, as new evidence pointed to China as the source of the tainted drug that killed as many as 21 Americans. The Food and Drug Administration is now making sure that all supplies of Heparin and its key ingredient are tested for the mysterious contaminant, agency officials told reporters yesterday. Manufacturers and importers will have to conduct the sophisticated tests or government inspectors will do so before the products can be distributed in the United States.
NEWS
By Jonathan D. Rockoff and Jonathan D. Rockoff,Sun reporter | March 7, 2008
After more reports of serious side effects, the government urged American drugmakers and their suppliers yesterday to test Heparin products for a mysterious chemical that might have killed several users of the widely used blood thinner. The Food and Drug Administration asked the handful of companies that make Heparin products or their main ingredient to conduct the sophisticated tests for the contaminant. The FDA made the request after authorities in Germany warned that Heparin made there was causing a spike in side effects and issued a recall.
NEWS
By Jonathan D. Rockoff and Jonathan D. Rockoff,Sun reporter | March 15, 2008
WASHINGTON -- The government is ratcheting up testing of the blood thinner Heparin and its main ingredient, as new evidence pointed to China as the source of the tainted drug that killed as many as 21 Americans. The Food and Drug Administration is now making sure that all supplies of Heparin and its key ingredient are tested for the mysterious contaminant, agency officials told reporters yesterday. Manufacturers and importers will have to conduct the sophisticated tests or government inspectors will do so before the products can be distributed in the United States.
NEWS
By Jonathan D. Rockoff and Jonathan D. Rockoff,Sun Reporter | March 13, 2008
WASHINGTON -- On Jan. 4, Dr. Alexis M. Elward, a troubleshooter at St. Louis Children's Hospital, was summoned to investigate severe allergic reactions in two children undergoing dialysis there. Elward -- an Annapolis native trained in Maryland -- quickly mobilized a team of investigators and alerted authorities, the start of an international probe into contamination of the blood thinner Heparin. The government's publication of her alert triggered an outpouring of similar reports, which resulted in a major recall of the popular drug last month.
NEWS
By Jonathan D. Rockoff and Jonathan D. Rockoff,Sun reporter | March 7, 2008
After more reports of serious side effects, the government urged American drugmakers and their suppliers yesterday to test Heparin products for a mysterious chemical that might have killed several users of the widely used blood thinner. The Food and Drug Administration asked the handful of companies that make Heparin products or their main ingredient to conduct the sophisticated tests for the contaminant. The FDA made the request after authorities in Germany warned that Heparin made there was causing a spike in side effects and issued a recall.
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