Dallas Fort Worth Injury Lawyer Blog

Canadian health regulators have added new label warnings to Pradaxa, the new blood thinner. In Canada it is known as Pradax. The regulators are warning that the risk of bleeding events may be increased among patients with kidney problems.

The Pradaxa warnings were announced on March 16, and recommend that all patients should have their renal function assessed before starting Pradaxa, and that doctors should assess any changes in renal function while on the treatment, especially among patients over 75 years old.

Health Canada indicated that use of Pradaxa was not recommended for patients with rheumatic valvular heart disease, especially mitral stenosis, or patients with prosthetic heart valves, as the safety and efficacy of Pradaxa has not been studied among those patients.

New medical research suggest that the popular diabetes drugs Byetta and Januvia could increase the risk of pancreatitis and pancreatic cancer.

In a study published this summer in the medical journal Gastroenterology, researchers from the University of California, Los Angeles (UCLA) found a nearly threefold increase in reported cases of pancreatic cancer and a sixfold increase in reported cases of pancreatitis among Byetta and Januvia users.

Researchers also found an increase in thyroid cancer among Byetta users.

A medical study published in the British medical journal, Lancet, has identified that all-metal on metal artificial hips fail more often than other designs. This confirmation has increased concerns about the implants and the researchers are calling for a ban.

British experts at the world’s biggest artificial joint registry said doctors should stop using metal-on-metal hip replacements, citing an analysis showing they have to be fixed or replaced more often than other implants.

The medical analysis in The Lancet, was published recently after Britain’s medical regulators said nearly 50,000 Britons with metal-on-metal hips needed annual check-ups to monitor for problems, including exposure to toxic metals.

Federal lawsuits against Wright Medical Technology, a manufacturer of metal-on-metal hip-replacement is now being consolidated in Multi district Litigation (MDL). Wright Medical Technology’s Conserve Plus implants are under assault for causing injuries similar to those produced by the DePuy ASR and Pinnacle metal on metal hip system.

This is one of three MDLs organized to consolidate pre-trial proceedings for plaintiffs suing over dangerous and defective metal on metal hip implants. The Wright Conserve MDL has been consolidated in the U.S. District Court for the Northern District of Georgia.

DePuy ASR MDL

Bleeding side effects in patients treated with Pradaxa have led a group of New Zealand hematologists to sound the alarm and call for better doctor education.

The hematologists wrote of their concerns in a letter published in the March 1 issue of the New England Journal of Medicine. In a two-month review, they identified 78 bleeding episodes, including 12 major bleeds, one of which might have contributed to a patient’s death,

Many of the bleeding incidents involved older patients and patients with reduced kidney function. Importantly prescriber error occurred in about 25% of the complications, revealing a lack of awareness of the potential risks associated with the drug.

According to Cleveland Clinic researchers, Pradaxa patients taking the new anti-clotting drug Pradaxa have a 33% higher risk of heart attack or severe symptoms of heart disease than do patients taking warfarin.

This finding, from Ken Uchino, MD, and Adrian V. Hernandez, MD, PhD, is based on data from seven clinical trials that enrolled 30,514 patients.

According to Uchino and Hernandez, “the risk of [heart attack] or acute coronary syndrome is increased with [Pradaxa] compared with various control treatments, which include adjusted-dose warfarin, [Lovenox], or placebo.”

U.S. District Judge Danny Reeves, has dismissed generic Darvon and Darvocet lawsuits. A recent US Supreme Court decision shields generic drug makers from responsibility to warn patients and doctors about the dangers of associated with generic copies of brand name medications they manufacture and sell.

The dismissals were based on the U.S. Supreme Court’s 2011 decision in Pliva Inc. v. Mensing, which found that generic drug companies can not be held liable for failing to warn about side effects, so long as their labels are identical to those of the original brand-name product.

Following the recall of Darvon and Darvocet, a number of product liability lawsuits have been brought against manufacturers of the name-brand medications, as well as manufacturers of generic equivalents.

Taking Pradaxa, are you playing Russian Roulette with a potentially lethal drug? Is it the case of Head you lose, Tails you lose? Taking your life into your hands should not come down to a flip of the coin.

There is no antidote or treatment to reverse the bleeding side effects of Pradaxa. According to a newly published case study, this lack of treatment is proving deadly to many patients.

The Journal of Neurosurgery has published a report, in which researchers pinpoint the risk associated with hemorrhages from Pradaxa.