Sanofi Has Sent Out "Dear Doctor" Letters About The Association Of Plavix (Clopidogrel) Acquired Hemophilia There -- Why Not Here, Too
UPDATE: This label revision regarding hemophilia is set forth in a December 12, 2013 FDA Supplemental Approval letter sent to Sanofi Aventis:
Under section 6, ADVERSE REACTIONS, sub-section 6.2 Postmarketing Experience, the following changes were made:
o To “Blood and lymphatic system disorders”, “acquired hemophilia A” was added
About six weeks ago we saw this article, "Sanofi Alerts United Kingdom of Haemophilia Cases associated with Plavix Treatment", which was published by The AdverseEvents Research Team.
It began with this information:
On September 17, 2013, Sanofi disseminated letters to healthcare professionals in the United Kingdom, warning of the link between clopidogrel (Plavix) and acquired haemophilia. All reported cases of haemophilia occurred in patients with no prior history of the disease.
We waited a bit to see if and when a similar letter would be sent out in the U.S. -- but two months later we have not seen or heard about a corresponding letter here.
The UK version of this so-called "Dear Doctor" letter sent by Sanofi about Plavix and associated cases of "haemophilia" (hemophilia, here) is undated.
Strictly Confidential, No Obligation.
In relevant part, from that Sanofi "Dear Doctor" Plavix letter about hemophilia:
Further information on the safety concern
Acquired haemophilia A is a very rare autoimmune disease. The incidence is estimated
in the literature at 1 to 4 patients per million, per year. Morbidity and mortality are high
due to the often older age of patients, underlying diseases, bleeding and toxic effect of
11 case reports of acquired haemophilia A and 1 case report of acquired haemophilia B
associated with clopidogrel treatment have been transmitted to sanofi or published in
the literature since the launch of the product:
These involved 8 males, 2 females and the gender was unknown in 2 patients.
The age range was between 65 and 81 years.
Time to onset (where reported) ranged from a few days to 4 months after starting
Two cases were life-threatening and none had a fatal outcome.
Reaction abated after clopidogrel discontinuation and corrective treatment in 5 out
of the 8 patients for which the information on the outcome was made available.
Product Information is being updated with information on this risk...
In reviewing the current Bristol-Myers Squibb/Sanofi Pharmaceuticals Plavix Prescribing Information (Revised September 2013) found on the FDA's website (accessed 10/30/13), however, there is no mention of hemophilia in that document.
Perhaps a revised Plavix label is awaiting FDA approval, or maybe Bristol-Myers and Sanofi are not going to add any hemophilia warning here in the U.S.
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