Based on this study of Pradaxa, which reviewed data from multiple clinical trials involving tens of thousands of patients, there is simply too high of a risk to allow this drug to remain on the market.
Baltimore, MD (PRWEB) January 12, 2012
Baltimore drug injury lawyer Robert K. Jenner today called for an immediate recall of Pradaxa in light of a recently released study that linked use of the blood-thinning drug to a heightened risk of heart attacks.
The study, published January 9 in the Archives of Internal Medicine, found that patients using Pradaxa had a 33 percent higher risk of heart attack or acute coronary syndrome (ACS) than patients taking another blood thinner or a placebo, according to a report by CBS News.
“Drug manufacturers owe patients a duty to carefully test and monitor the pharmaceuticals they produce, or else patients are exposed to the risk of serious injury or even death,” said Jenner, whose nationally recognized Baltimore personal injury firm is investigating claims of injuries to Pradax users across the country.
“Based on this study of Pradaxa, which reviewed data from multiple clinical trials involving tens of thousands of patients, there is simply too high of a risk to allow this drug to remain on the market.”
Pradaxa (or dabigatran) is manufactured by Boehringer Ingelheim, a German-based pharmaceutical company. The anti-coagulant drug reduces the risk of strokes, which can lead to disability or death, by thinning the blood. It has been on the U.S. market since October 2010.
According to a December 2011 safety communication released by the U.S. Food and Drug Administration, serious and potentially fatal bleeding is a well-recognized complication of all anti-coagulant therapies.
However, the FDA said it was “working to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected, based on observations in the large clinical trial that supported the approval of Pradaxa.”
In the study published in the Archives of Internal Medicine, two Cleveland researchers (Ken Uchino, MD, and Adrian V. Hernandez, MD, PhD) reviewed data from seven clinical trials that involved 30,514 patients, according to a Bloomberg News report on the study.
Out of 20,000 patients taking Pradaxa, 237 had heart attacks or experienced ACS. In contrast, the same complications were experienced by 83 patients out of the 10,514 taking the drug warfarin or a placebo, the researchers found.
The researchers concluded that “[Pradaxa] is associated with an increased risk of [heart attacks or ACS] in a broad spectrum of patients when tested against different controls. Clinicians should consider the potential of these serious harmful cardiovascular effects with use of [Pradaxa].”
“A patient taking Pradaxa needs to know the common side effects associated with this drug so they can recognize them immediately if they occur and contact a doctor right away,” Jenner said. “It’s also important to contact an attorney with experience in investigating drug injury cases in order to review the facts of your case and determine your legal rights and options.”
About Janet, Jenner & Suggs, LLC
The law firm of Janet, Jenner & Suggs, LLC, is a nationally recognized law firm dedicated to representing victims of defective products, medical devices, prescription drugs and medical malpractice. Each of the firm’s principals is named in The Best Lawyers in America® and Super Lawyers®. The firm has offices in Baltimore, Maryland; Columbia, South Carolina; and Asheville, North Carolina. The firm accepts clients and referrals from clients and attorneys throughout the country. For more information about claims related to Pradaxa, contact the firm at (877) 692-3862 or through the firm’s Pradaxa website.