Our team of product recall lawyers announce that a Class I recall was recently initiated for Alere PT/INR Professional Test Strips, which are used to monitor anticoagulant drugs status at home. Patients taking oral anticoagulant drugs like warfarim, Coumadin, Pradaxa or heparin, should check their brand of PT/INR test strips immediately. Three patients have died due to the defective strips.
The specific product being recalled is the Alere INRatio 2 PT/INR Professional Test Strips (PN 99008G2). Patients using these strips are experiencing false reads on them, meaning that patients with dangerously high INR readings are seeing inaccurate results on their strips. These defective products are telling patients that their INR readings are normal when they are in reality dangerously, even fatally high.
Alere has received several reports of patient injury, including three deaths from false INR readings. The company reports that the strips can read anywhere between 3.1 and 12.2 units lower than the actual INR. This can cause patients to suffer spontaneous bleeding episodes, which can ultimately result in fatal bleed-outs. All three deaths were associated with uncontrollable bleeding.
The manufacturer has not yet stated how or why the products are defective, and stated that all patients using these strips should have received a letter around April 16, 2014 informing them of the problems. Anticoagulant and blood-thinning therapy is prescribed to patients who have recently undergone heart valve surgery, have a history of heart attacks, or suffer from an irregular heartbeat (atrial fibrillation). Drugs like warfarin, heparin, Coumadin, and Pradaxa help prevent blood clots that could cause strokes and heart attacks in these vulnerable patients.
This month, the Journal of Neurosurgery reported that the side effects of popular blood thinner Pradaxa are just as fatal and irreversible as from defective testing products. The authors of that report focused on one Pradaxa patient, an elderly man, who had been on the drug for just one month. The man suffered a seemingly minor fall at his home, and despite immediate medical care, doctors were unable to stop his intracranial bleeding, taking his life.
Pradaxa is commonly prescribed to elderly patients, and far too many fatal bleeding episodes are triggered by falls at home or in nursing homes. Patients over the age of 75 with pre-existing kidney conditions should be extremely cautious when considering taking a blood thinner, particularly Pradaxa.
This is because, unlike warfarin, Coumadin and heparin, Pradaxa has no
antidote. Meaning, if a patient on a warfarin blood thinner starts to
bleed uncontrollably, the effects can be reversed with a high dose of
Vitamin K. This therapy does not exist for Pradaxa, so patients who start
to bleed, even minimally, may suffer fatal bleed-outs while doctors watch
Studies show that patients who suffer an internal bleeding event while on Pradaxa are five times more likely to die than those bleeding while on warfarin. Other studies found that Pradaxa may also increase the risk and severity of particular viral infections. The first year that Pradaxa was on market, from 2010 to 2011, it caused about 550 patient deaths.
Because of this, Pradaxa’s manufacturer is facing mounting lawsuits filed by families who lost loved ones. These are very strong cases, hundreds of which are currently pending in court. The Pradaxa attorneys at Pintas & Mullins Law Firm are currently investigating cases of serious or fatal bleeding from this drug. If you or someone you love was prescribed Pradaxa and suffered a serious injury, contact our firm immediately for a free case review.