Several days ago, a compendium of the safety reports of the FDA was published by the Institute for Safe Medical Practices. These safety reports arrive at the FDA in several ways. They are reported to the FDA by drug companies, by physicians and by patients. The Institute for Safe Medical Practices is an independent nonprofit organization located at www.ismp.org. It correlates and then analyzes the reports to attempt to identify trends. I will now report on those findings. In 2011, the FDA received 179,855 reports of serious, disabling or fatal adverse drug events. During this time, 48% of the population in the United States was taking a prescription drug, and 3.6 billion outpatient prescriptions were dispensed. As I have blogged about before, I believe that the number of drug-related safety reports is woefully undercounted as the reporting is voluntary. The system is upside down. Drug approval should be shortened and then permanent follow up should be instituted in some way. In today's information age, we should be able to accommodate this. The vaunted Electronic Medical Record could help, but that is a blog for another day. I find it hard to believe that 3.6 billion prescriptions were dispensed but only 179,855 reports were generated. Having said this, it is perhaps more worrisome that most of these reports refer to Pradaxa and warfarin. Yup. They are one and two. We have used warfarin since 1954, and it is still the second most dangerous drug around. Luckily, we have now created another compound that does the same thing and is perhaps more dangerous. Now that's what I call progress. According to this report, Pradaxa accounted for 3,781 reports and 542 deaths. Among the reports were 2,367 reports of hemorrhage, 291 of acute renal failure and 644 strokes. Warfarin had 72 deaths and 1,106 reports. Why is this important? The uptake of Pradaxa and now Xarelto has been rapid as these types of drugs have been eagerly awaited for years. The dream of "relatively" safe anticoagulation that does not need monitoring has been a long time coming. Perhaps the most significant problem with Pradaxa is the lack of dosing ability. As I blogged about in the past, the FDA dreamed up the 75 mg dose of Pradaxa. The dose that was tested was 150 mg and a 110 mg dose. These are the doses that were approved in Europe. The FDA used a graph to figure out dosing by renal function. Maybe it is not right. These reports are in isolation. It is not clear what doses caused the problems, and it is not clear the age variation. What is clear, and I am very careful to explain this to my patients , is that we cannot reverse the effect of the drug. It must wear off, and depending on the clinical issues, that can be very challenging. Coumadin has fresh frozen plasma, which although it takes some time to get, we eventually do get it to reverse the warfarin. I believe we must be more careful in the use of these drugs. We need to monitor renal function more closely. Xarelto, the second in the class, can be monitored, and I am using more of it now. It is also once a day. It takes time for drugs to settle in. I have seen this before but not with such consequences. I'm sure we will get the hang of it. If you are on Pradaxa, you need to discuss it with your doctor and make sure that you are carefully followed. This is not the last we will hear about this.
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