Has Boehringer-Ingelheim experienced a “Come to Jesus Moment”?
Several news sources recently announced that the German pharmaceutical giant, whose flagship product Pradaxa has been implicated in several cases of fatal bleeding, has issued a recall – of Pradaxa.
But only one lot. And not because it may be dangerous and there is no antidote for the hemorrhaging. No...it turns out there was a packaging defect. Apparently, the machinery used to package the medication has caused a defect in the bottles that may allow moisture to enter and prevent patients from receiving a “fully effective dose.” BI advises patients who have a bottle with Lot Number 201900 and an expiration date of January 2015 should return it to the pharmacy for exchange. The company also warns patients to continue taking the medication until their bottle has been replaced.
Both the Food and Drug Administration and BI have said that the danger of hemorrhaging is no worse when taking Pradaxa than it is when using warfarin. This isn't the issue. The problem is that when a patient starts hemorrhaging while taking warfarin, it can be stopped with doses of Vitamin K, which allows the blood's clotting factor (thrombin) to kick in. Pradaxa (dabigatran) operates on the clotting factor itself, preventing it from working – so once hemorrhaging stops, there is virtually no way to stop it, except to attempt emergency dialysis. This issue was not addressed by either the FDA or BI.
Where BI allegedly went wrong was in its failure to warn physicians and patients. The objective of current litigation against the company is to determine what management knew and whether or not there was a duty to warn consumers of the drug.
Meanwhile, Pradaxa has generated over $1 billion in sales. At the same time, a recent report in Forbes raises serious questions about the FDA's methods in analyzing the risks associated with Pradaxa. The FDA relied on data from insurance claims and administrators, not medical case files. According to the Observational Medical Outcomes Project, a non-profit organization devoted to the study and analysis of new medications, reliance on such non-medical data is questionable at best.
FDA Drug Safety Communication: “Update On The Risk For Serious Bleeding Events With The Anticoagulant Pradaxa,” 02 November 2012. Available at http://www.fda.gov/Drugs/DrugSafety/ucm326580.htm .
MacDonald, Gareth. “Boehringer Withdraws Pradaxa Lot After Packaging Line Problems.” InPharma Technologist, 12 November 2012. Available at http://www.in-pharmatechnologist.com/Processing/Boehringer-withdraws-Pradaxa-lot-after-packaging-line-problems.
N/A. “Boehringer Recalls Manufacturing Lot of Pradaxa.” Bloomberg Businessweek, 7 November 2012.
Silverman, Ed. “Was The FDA Safety Analysis For A Popular Bloodthinner Flawed?” Forbes, 6 November 2012.