Monday, January 26, 2009
Health regulators in the United States reported on Monday that they are reviewing the effectiveness of the widely used anticoagulant Plavix, made by Sanofi-Aventis SA and Bristol-Myers Squibb, in some patients.
The action comes after several studies showed that the popular drug did not work so well in some people, possibly because patients metabolize them differently according to their genetic or consumption of other drugs.
Bristol and Sanofi had agreed to conduct studies on the interaction of genetic and drug Plavix, also known as clopidogrel bisulfate, said in a statement published on its website the Food and Drug Administration of the United States (FDA by its Spanish acronym).
"This information should lead to a better understanding of how to optimize the use of clopidogrel," added the agency.
Laura Hortas, a spokesman for Bristol, said he had no details on how many companies would need to study or how long it will take steps.
The result "will allow us to understand and characterize the factors that influence this complex issue," said Hortas on behalf of both laboratories.
While some reports have suggested a possible interaction makes Plavix less effective, other research found no such problem, the FDA said.
Plavix is an antiplatelet which aims to reduce the risk of dangerous blood clots that could cause heart attacks and strokes (CVA). To operate, you must first be metabolized by the body, according to the FDA.
One type of medication usually prescribed to patients treated with Plavix are antacids such as Nexium and Prilosec AstraZeneca PLC and other inhibitors of proton pump, the federal agency said.
However, the FDA said that doctors and patients should continue using Plavix until there is more data available.
Doctors should reassess the use of some antacids, including versions sold in the patients taking Plavix, the FDA said.
The FDA said that the laboratories had agreed on a timetable for carrying out the studies, but gave no further details. The agency added that it could take months to review the findings after the completion of investigations.
The communique from the FDA is available in English, http://www.fda.gov/cder/drug/early_comm/clopidogrel_bisulfate.htm.
Labels: Health
