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Drug Safety Experts Say FDA Allowing Dangerous Drugs on the Market

Drug safety experts report that the U.S. Food & Drug Administration (FDA) is allowing dangerous drugs to find their way to market. The article was published, today, in the Journal of the American Medical Association.

The article blames the agency’s work to speed approval of new drugs to be what has allowed stroke prevention, cancer, and multiple sclerosis medications to be released without proper safety reviews, said The Wall Street Journal. The article, written by drug safety experts Thomas J. Moore and Curt D. Furberg, states that, in the agency’s zeal to approve medications, they might have mitigated prescription-drug safety. The pair pointed to a multiple sclerosis (MS) drug that has some significant cardiac side effects as well as numerous other risks, as well as Pradaxa, an anticoagulant linked to dangerous bleeding that can be “difficult to treat,” said The Journal. (more…)

Pradaxa Patients Await Word On MDL

Pradaxa patients, involved in about 12 dozen lawsuits in Illinois alone, are awaiting word on multidistrict litigation (MDL) concerning injuries they allege are linked to the controversial blood thinner.

The 12 Illinois lawsuits represent about half of what Boehringer Ingelheim Pharmaceuticals, Inc., and some other foreign corporations in the United States, face. Boehringer is the maker of Pradaxa. The cases have been filed since May of this year in the U.S. District Court for the Southern District of Illinois, said the Madison Record; plaintiffs are waiting to learn if an MDL will be created to handle the claims. Eight complaints were filed against Boehringer in May in the East St. Louis federal court; three were filed in June, and another was filed this month, the Madison Record explained. (more…)

Pradaxa Leads In Fatality Reports To FDA

Blood thinner, Pradaxa, is the leader in fatality reports to the U.S. Food & Drug Administration (FDA), according to a new report.

It seems, said FiercePharma, that Pradaxa, manufactured by Boehringer Ingelheim, was involved in more fatality reports to the FDA than any other drug last year. In fact, Pradaxa was the lead in reports in a number of categories: Overall reports, 3,781; deaths, 542; hemorrhage, 2,367; acute renal failure, 291; and stroke, 644, said FiercePharma, citing The Philadelphia Inquirer’s health blog that cited an Institute for Safe Medication Practices’ (ISMP) QuarterWatch program report. The report obtained data from the FDA MedWatch reporting system.

NewsInferno recently wrote that European regulators again asked Boehringer Ingelheim to update the Pradaxa to include additional information about bleeding side effects. The European Medicines Agency (EMA) said that the new guidance should include added information on when Pradaxa must not be taken and information concerning managing patients and reversing the anticoagulant effect, should Pradaxa bleeding occurs.

Approved in Europe in March 2008, Pradaxa was introduced for the prevention of venous thromboembolic events after hip or knee replacement surgery, NewsInferno explained. Pradaxa just had its European approval expanded to cover non-valvular atrial fibrillation for prevention of stroke and systemic embolism. Fatal Pradaxa bleeding events rose after the expansion, according to a Pharma Times report, said NewsInferno.

Pradaxa was the first of a new class of blood thinner medications called direct thrombin inhibitors, and is marketed as a safer alternative to Coumadin (warfarin), NewsInferno explained. Coumadin has some challenging issues including that it can cause dangerous interactions with other medications, that patients must avoid foods high in vitamin K (leafy greens, liver, green tea, cauliflower), and that patient blood must be monitored on a regular basis, noted NewsInferno.

While Pradaxa was touted as avoiding these issues, Pradaxa, Coumadin, and all blood thinners, can cause serious internal bleeding. The major issue is that, with Pradaxa, there are no antidotes to the bleeding, said NewsInferno. As a matter-of-fact, some recent Pradaxa bleeding fatalities have involved patients who died from serious internal bleeds after relatively minor traumas, such as falls involving head bumps. Similar drugs include Eliquis, from Bristol-Myers Squibb and Pfizer, and Xarelto from Johnson & Johnson, noted FiercePharma.

Last year, the FDA initiated a Pradaxa review over reports of bleeding-related side effects. Japanese regulators also directed Boehringer Ingelheim to strengthen Pradaxa warnings, said NewsInferno.

Meanwhile, in the face of mounting controversy and consumer lawsuits, Boehringer Ingelheim just issued a release stating that Pradaxa’s prescribing information has been updated to indicate that Pradaxa is superior to warfarin in reducing ischemic and hemorrhagic stroke, said FiercePharma.

Pradaxa Death Blamed On Irreversible Bleeding

At least one Pradaxa death is being blamed on irreversible bleeding. Pradaxa (dabigatran), approved by the U.S. Food & Drug Administration (FDA) October 2012, is prescribed as a blood thinner for patients diagnosed with atrial fibrillation to prevent stroke. Although both Pradaxa and warfarin—known by the brand name Coumadin, which has been marketed for decades—pose risks for serious bleeding. Where warfarin’s bleeding side effect can be contained, Pradaxa’s cannot: There is no reasonable antidote for Pradaxa bleeding, noted NewsInferno; however, Pradaxa is touted as a better alternative to warfarin. (more…)

Medical Journal Details Pradaxa Bleeding Death Of Elderly Man Following Fall

Medical periodical, the Journal of Neurosurgery, has detailed the Pradaxa bleeding death of an elderly man. Pradaxa (dabigatran), approved in 2010, is manufactured by Boehringer Ingelheim and is a recently approved medication in the class known as direct thrombin inhibitors used to prevent strokes in patients diagnosed with atrial fibrillation.

The man died after a fall, said Reuters, and the complications from his fall point to potentially irreversible bleeding complications associated with Pradaxa, according to the Journal of Neurosurgery. (more…)

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