As a Geriatric Social Worker I am Extremely concerned about our senior population on the blood thinner Pradaxa. Pradaxa has no antidote to begin clotting and can lead to severe Brain bleeds. I am reaching out to Home health aides for their patients on Pradaxa.
Pradaxa Side Effect Reports about extensive bleeding and Hemorrhaging
By Ed Silverman // January 11th, 2012 // 12:11 pm
Just when you thought the clouds hovering the Pradaxa bloodthinner could not get any darker, yet another report underscores concern about the Boehringer Ingelheim drug. The latest missive shows there were 505 cases of hemorrhaging reported to the FDA in the first quarter of 2011, shortly after the med was approved for preventing stroke and blood clots in people with atrial fibrillation.
The cases resulted in death, disability, hospitalization or some other serious outcome, and the median age of the patients was 80, suggesting that the oldest and most vulnerable patients were hemorrhaging due to a drug overdose, according to the Quarter Watch reported from the Institute for Safe Medicine Practices, a non-profit. In fact, 25 percent of the affected patients 84 years or older.
The findings come three months after European regulators asked doctors to exercise caution about using the Pradaxa bloodthinner. At the time, the European Medicines Agency was aware of 256 cases of serious bleeding that resulted in patient deaths associated with the drug. More recently, the FDA decided to investigate post-marketing reports of serious bleeding patients
And earlier this week, an analysis of seven clinical trials that was published in the Archives of Internal Medicine found Pradaxa was “significantly associated with a higher risk” of heart attacks and acute coronary syndrome, which includes heart attacks and chest pain. Of 20,000 patients taking Pradaxa, 237 had a heart attack or chest pain, compared with 83 patients out of 10,514 on warfarin, which is the decades-old standard treatment, or a placebo
The mounting evidence that Pradaxa is associated with serious adverse events is a boost to rivals. Two months ago, the FDA approved Xarelto, which is sold by Bayer and Johnson & Johnson, although the bloodthinner received a Black Box warning And Eliquis, which will be sold by Pfizer and Bristol-Myers Squibb and has generated heady predictions of success on Wall Street, received a priority review
The adverse events, meanwhile, suggest that the FDA should revisit dosing for Pradaxa, according to ISMP. The non-profit noted that in the 2011 first quarter, there were 272,119 prescriptions dispensed to outpatients, and 932 overall serious adverse events reports in which the bloodthinner was the primary suspect, including 120 deaths, 25 cases of disability and 543 cases requiring hospitalization.
A key issue, according to ISMP, is that Pradaxa was approved at a dose of 150mg twice a day, but the frequent laboratory tests needed to manage warfarin blood levels – every one to four weeks – were not recommended. The INR (International Normalized Ratio) test used to optimize warfarin treatment does not provide reliable results for Pradaxa, the non-profit notes. As a result, patients are not routinely monitored to see if they are getting too much of the drug.
And while declining or impaired kidney function is another potential safety issue, the prescribing info does not recommend a dosage adjustment, except in cases of severe renal impairment, and does not recommend regular testing of renal function, ISMP writes. The non-profit notes mild kidney impairment raises Pradaxa blood levels by 50 percent and moderate impairment can increase levels by 300 percent.
“While more study is needed, it may turn out to be a major drug safety mistake for the FDA to have approved a one-dose-fits all drug intervention as risky and sensitive as an anti-coagulation in older patients,” Thomas Moore, senior scientist at ISMP
ISMP adds, by the way, that Boehringer was approached for comment, and the drugmaker responded by acknowledging the large volume of serious adverse events were known, but noted that bleeding risks were known and warnings were issued. The drugmaker “attributed the report volume in part to the rapid acceptance of the drug into the market and an active sales force with extensive contact with physicians, resulting in more frequent reports,” according to ISMP. Boerhinger added that it is working with the FDA to provide better guidance to physicians. Separately, we asked Boehringer for a response and will update you accordingly if one is received.
Our Florida seniors are vulnerable to the effects of pradaxa. if your parent, grandparent, father or loved one is on Pradaxa watch for sign of extensive bleeding or unusual bleeding. Any change in stool color may be a sign of internal bleeding. Any change in cognition may be a sign of a brain bleed. Call our Pradaxa Help Center and Speak to a Geriatric social worker. if a loved one is injured or dies from extensive bleeding and is on pradaxa you may be able tp take part in the pradaxa lawsuits. These are not against doctors but the manufacturers for not letting us know what we were doing when we took this medication in the first place. A stroke is a serious illness and should be prevented but medications that cause extensive bleeding and have no antidote to make the blood clot in an emergency are even more serious. We must send a ,essage and protect our vulnerable and precious parents and grandparents.