FDA Reviewing Serious Side Effects Associated With Pradaxa Ranging From Heart Attacks To Serious Bleeding or Hemorrhages
UPDATE: Pradaxa label change: This January 17, 2012 FDA approval letter shows the revisions being made to current label.
Patients who use the new stroke drug Pradaxa (dabigatran) have slightly increased risks for heart attack, or myocardial infarction (MI), and acute coronary syndrome (ACS) relative to those patients who used another anticoagulant medication warfarin or a placebo, according to new study report published in early January 2012 by the Archives of Internal Medicine.
As reported by Jennifer Corbett Dooren in her January 10, 2012 Wall Street Journal (WSJ) article, "Study Finds Risk in New Stroke Drug":
The original Pradaxa study the company used to gain FDA approval suggested a small increased risk of heart attack with the use of the drug compared to warfarin. Researchers since then have been trying to figure out whether there's really an increased risk. The study found the drug cut the risk of strokes by 35%.
According to an analysis by two Cleveland Clinic researchers published online in the Archives of Internal Medicine, Pradaxa boosted the risk of a heart attack and a condition known as acute coronary syndrome by 33%....
The study's lead researcher Ken Uchino, a Cleveland Clinic neurologist, said the actual increase in the number of heart attacks and acute coronary syndrome events was very small and is outweighed by the benefit of the drug's ability to reduce the number of strokes.... Dr. Uchino and other researchers called for more study of the drug's potential to increase heart-attack risk.
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As regards what weight should be given this latest Pradaxa medical journal article, we turn to another January 10 news report, "Blood-thinning drug Pradaxa is linked to heart attack risk":
... Dr. Jeremy M. Jacobs, a senior physician at Hadassah Hebrew University Medical Center in Jerusalem, said doctors should ratchet down their enthusiasm for dabigatran until more research can be done to clarify the potential heart attack risk.
"I think caution is needed especially among patients with known active ischemic heart disease," said Jacobs, who co-wrote an editorial published with the report.
Recent history has taught medical professionals that the full effects of a new medication may not be apparent until it is in widespread use - sometimes years after FDA approval, Jacobs noted. For example, the painkiller Vioxx was on the market for almost five years before it became clear that it was associated with an increased risk of heart attacks and strokes; it was withdrawn in 2004.
As regards other types of adverse event reports concerning Pradaxa, we refer you to these two relatively recent Drug Injury Watch articles:
- "Pradaxa: FDA Investigating Possible Higher Than Expected Incident Rate Of Serious Bleeding Side Effects" (December 15, 2011); and,
- "New Heart Drug Pradaxa May Be Sending "Early" Drug Safety Signals" (October 13, 2011).
We will continue to monitor the safety of Pradaxa and report what the FDA determines following its current review of the Adverse Event Reports (AERs) which the agency has received to date.
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