Monday, August 26, 2013

Public Citizen petitions the FDA for a black box regarding a clopidogrel

I am not passing judgment on the wisdom of this, just making this document available
Clopidogrel warning via Public Citizen

Here is a quote from it:

Public Citizen, representing more than 300,000 members and supporters nationwide, and 
Neil A. Holtzman, M.D., hereby petition the Food and Drug Administration (FDA), 
pursuant to the Federal Food, Drug and Cosmetic Act 21 U.S.C. Section 355(e)(3) and 21
C.F.R. 10.30, to immediately add a black-box warning on clopidogrel (brand name: 
Plavix, as well as generic equivalents). The black-box warning must address the 
increased risks of major and minor bleeding with use beyond 12 months following 
implantation of drug-eluting coronary artery stents. Such warning is made necessary both 
by a lack of evidence of a further reduction of thrombotic cardiovascular events, such as 
myocardial infarction or stroke, as well as existing evidence of continued risk of major 
bleeding with more prolonged use. We also urge the FDA to require the distribution of an 
FDA-approved, updated Medication Guide containing this information to be dispensed to 
all patients when their prescriptions are filled and to ask companies to send a “Dear 
Doctor” letter to warn physicians of these preventable adverse effects that occur with use 
for greater than one year.

Follows is a link from Sanofi that gives extensive product information on Plavix.
Sanofi info on Plavix

There are two passages I am quoting regarding Plavix and excessive bleeding.

Page 7
Adverse Drug Reaction Overview
The safety profile of clopidogrel has been evaluated in clinical trials in more than 44,000 patients including over 1200 patients treated for 1 year or more and further assessed during post-marketing experience.
Of the patients who participated in the CAPRIE, CURE and CLARITY double-blind international clinical trials, approximately 50% were elderly patients (> 65 years) and 15% were 75 years and older. In the ACTIVE A trial, 75% of patients treated with PLAVIX were 65 years of age and older, and 41% were 75 years and older. In COMMIT study, approximately 58% of the patients treated with PLAVIX were 60 years and older, 26% of whom were 70 years and older.
The most frequent adverse drug reactions (≥1%) with PLAVIX (with or without associated ASA) in controlled clinical trials were hemorrhage and bleeding disorders including purpura, any rash, dyspepsia, abdominal pain and diarrhea (see "Clinical Trial Adverse Drug Reactions").
The most serious adverse drug reactions from controlled clinical trials rarely reported (<1%) were bleeding and clotting disorders including gastrointestinal hemorrhage, hemorrhagic ulcer and hemothorax.

Page 20
Overdose following clopidogrel administration may lead to prolonged bleeding time and
subsequent bleeding complications. Appropriate therapy should be considered if bleeding is
observed or suspected.
A single oral dose of clopidogrel at 1500 or 2000 mg/kg was lethal to mice and rats, and at 3000
mg/kg to baboons.
No antidote to the pharmacological activity of clopidogrel has been found. Platelet transfusion may
be used to reverse the pharmacological effects of PLAVIX when quick reversal is required.
For management of a suspected drug overdose, contact your regional Poison Control Centre.

No comments:


Blog Archive