Thrombotic thrombocytopenic purpura and clopidogrel -- a need for new approaches to drug safety

Article Abstract:

Doctors need to play a more active role in identifying adverse effects of newly approved drugs. Most drugs are tested before they are approved, but if a side effect is rare, millions of people will have to take the drug before the side effect is seen. In 2000, doctors reported 11 cases of a serious condition called thrombotic thrombocytopenic purpura in people who took the anticoagulant drug clopidogrel. This drug is related to another anticoagulant called ticlopidine that was known to have the same side effect. For this reason, it should have ben monitored more closely.

Editorial, Clopidogrel

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Von Willebrand factor-cleaving protease in thrombotic thrombocytopenic purpura and the hemolytic-uremic syndrome

Article Abstract:

An absence of von Willebrand factor-cleaving protein or its inhibition may be a factor in thrombotic thrombocytopenic purpura and hemolytic-uremic syndrome. These diseases are both bleeding disorders. Researchers analyzed blood samples from 53 patients with either condition for the presence of a protease that breaks down clumps of von Willebrand factor. These clumps could bind to platelets and prevent blood clot formation. All 30 patients with thrombotic thrombocytopenic purpura had low levels of the protease, and in many cases, an antibody was inhibiting the protease.

Health aspects, Proteases, Hemolytic-uremic syndrome

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Making medicines safer - the need for an independent drug safety board

Article Abstract:

The US needs a post-marketing drug safety program that is independent of the Food and Drug Administration. Once a drug is approved for marketing, consumers and physicians must rely on a voluntary reporting system to learn about adverse effects. Even if physicians report adverse effects in the literature, there is no organization that can investigate those cases. About 100,000 Americans die each year from adverse reactions to drugs. The US needs a drug agency similar to the National Transportation Safety Board, which investigates all aircraft accidents.

Drugs, Safety and security measures, Drug therapy, Adverse drug reactions

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