FDA Should Boost Plavix Warning For Stent Implants: Watchdog
A consumer watchdog has petitioned the FDA to add a Black Box warning to the widely used Plavix bloodthinner, citing evidence that usage for more than a year after having a drug-eluting stent implanted may lead to fatal bleeding without providing any additional benefits.
In its petition, Public Citizen points to randomized controlled trials and other studies indicating that taking Plavix for more than a year after a stent implant does not reduce the chance of death from cardiac causes, myocardial infarction or other thrombotic events, compared to usage for less than a year.
“The research shows that using this drug for more than 12 months puts people at risk of potentially life-threatening bleeding, without any evidence that it’s doing any good at that point,” says Sid Wolfe, founder and senior adviser to Public Citizen Health Research Group, in a statement.
The watchdog notes that the Plavix medication guide indicates that Plavix can cause serious bleeding and lead to death, and people who have a stent implanted but discontinue Plavix too soon face a higher risk of a blood clot, heart attack or death (read here).
But Public Citizen contends the FDA did not provide guidance on how physicians should determine whether a patient was at a low risk of bleeding, and contends many doctors continue Plavix use beyond 12 months - and some do so indefinitely. The watchdog also wants the FDA to update the medication guide and also send a so-called Dear Doctor letter to healthcare providers to alert them to the issue.
The petition was jointly filed by Neil Holtzman, a professor emeritus at the Johns Hopkins University School of Medicine, whose wife died in 2011 after taking the drug for more than two years following a stent implant. “The doctor didn’t know, and we didn’t know, that this drug that had significant risks was providing no additional benefit at that point,” he says in a statement.
The drug is marketed by Bristol-Myers Squibb (BMY) and Sanofi (SNY), although Bristol-Myers has the primary responsibility for marketing in the US. We asked for a comment and will update you accordingly. We should note that a key patent on Plavix expired last year in the US and Bristol reported that sales plummeted to $2.5 billion from $7.1 billion in 2011 (see page 3).
STORY ENDS HERE
In its petition, Public Citizen points to randomized controlled trials and other studies indicating that taking Plavix for more than a year after a stent implant does not reduce the chance of death from cardiac causes, myocardial infarction or other thrombotic events, compared to usage for less than a year.
“The research shows that using this drug for more than 12 months puts people at risk of potentially life-threatening bleeding, without any evidence that it’s doing any good at that point,” says Sid Wolfe, founder and senior adviser to Public Citizen Health Research Group, in a statement.
The watchdog notes that the Plavix medication guide indicates that Plavix can cause serious bleeding and lead to death, and people who have a stent implanted but discontinue Plavix too soon face a higher risk of a blood clot, heart attack or death (read here).
But Public Citizen contends the FDA did not provide guidance on how physicians should determine whether a patient was at a low risk of bleeding, and contends many doctors continue Plavix use beyond 12 months - and some do so indefinitely. The watchdog also wants the FDA to update the medication guide and also send a so-called Dear Doctor letter to healthcare providers to alert them to the issue.
The petition was jointly filed by Neil Holtzman, a professor emeritus at the Johns Hopkins University School of Medicine, whose wife died in 2011 after taking the drug for more than two years following a stent implant. “The doctor didn’t know, and we didn’t know, that this drug that had significant risks was providing no additional benefit at that point,” he says in a statement.
The drug is marketed by Bristol-Myers Squibb (BMY) and Sanofi (SNY), although Bristol-Myers has the primary responsibility for marketing in the US. We asked for a comment and will update you accordingly. We should note that a key patent on Plavix expired last year in the US and Bristol reported that sales plummeted to $2.5 billion from $7.1 billion in 2011 (see page 3).
STORY ENDS HERE
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