The latest in a string of trials alleging the popular diabetes drug Actos caused users to develop bladder cancer started last week in Philadelphia, with stakes high for Japanese manufacturer Taketa Pharmaceutical.
The company faces more than 7,500 lawsuits in federal and state courts around the country from patients who developed the disease after taking Actos.
With the market for newer anticoagulants growing to several billion dollars per year, it’s no surprise the leading competitors would spend a healthy chunk of change on advertising. Anyone with a TV has likely seen countless ads for Xarelto, Eliquis and Pradaxa.
What is somewhat unsettling, however, is that the manufacturers of these drugs also funnel millions of promotional dollars to doctors. Almost $20 million in just the past half year, to be exact.
With nearly $2 billion spent so far by German drug giant Bayer to settle Yaz blood clot lawsuits, it may come as a surprise that not one case has reached a jury decision. That could change this year as a new class of unresolved claims are being scheduled for trial.
In 2009, litigation got underway as a small number of lawsuits alleging Yaz blood clot injuries were consolidated to a dedicated federal court in Illinois. Since then, over 13,000 claims have been filed.
A study from Israeli doctors released last month added fuel to an ongoing debate over the safety of newer style oral blood thinner drugs, noting that medications like Xarelto and Pradaxa may carry greater risks for intestinal bleeding than standby option warfarin.
The comments are just the latest data in years of conflicting evidence from manufacturers and independent researchers. On one side, German companies Bohringer Ingelheim and Bayer have touted the clinical trials behind their drugs Pradaxa and Xarelto, saying the meds carry fewer risks than warfarin.
The American Medical Association’s official publication this week released a new study that adds further discussion to the safety of new-style anticoagulant drugs for those with atrial fibrillation. Specifically, it addressed whether they are more likely to cause intra-cranial hemorrhage.
For over 50 years, doctors prescribed warfarin for patients with atrial fibrillation to prevent blood clots and strokes. However, with severe diet restrictions and the requirement of regular blood testing, many sought an alternative.
The FDA issued a new warning last week for a popular antipsychotic drug used by millions of patients for bipolar disorder or schizophrenia after studies showed it may cause a deadly skin disease.
Geodon is the best-known version of the drug Ziprasidone, sold by Pfizer. It is also marketed under the brand names Zeldox and Zipwell by Actavis. It has been on the market since 2001 and is still prescribed to around 2.5 million people.
A federal panel this week ruled that a growing number of claims over the blood thinner Xarelto will be sent to one central federal court for faster handling.
The Judicial Panel on Multidistrict Litigation, which consists of seven judges from around the country, decides whether lawsuits filed in different states have similar issues that could best be handled by one court. This prevents repetitious evidence gathering and conflicting judicial decisions.
So far, around 8,000 patients in the United States have filed lawsuits against Japanese pharmaceutical giant Taketa alleging their blockbuster diabetes drug Actos caused them to develop bladder cancer.
Bloomberg reports eight of these cases have reached trial already, with five resulting in verdicts for the victims. In April, a jury awarded an astonishing $9 billion to a New York man afflicted with bladder cancer after Actos use.
A new study released this year suggests that the birth control pills Yaz and Yasmin are just as safe, and no more likely to cause blood clots, as other types of oral contraceptives.
The only problem is, the study was funded by the company trying to sell the drugs, and is disputed by years of independent research.
Since Bayer and Johnson & Johnson released their joint-effort blood thinning drug Xarelto on the public in 2011, they have seen overwhelming sales growth: the once-a-day blood clot preventative has taken over previous sales leader Pradaxa and completely outpaced rival Eliquis.
A report compiled last month by industry tracker FirstWord Pharma demonstrates just how much Xarelto has overtaken the anticoagulant market though. In the past 12 months, it has grown from $1.6 billion in yearly sales to a now staggering rate of $3.2 billion.
Bayer and Johnson & Johnson’s joint-effort blood thinner Xarelto has experienced rapid growth since it was introduced in 2011 and now sits atop the popular blood clot-prevention market.
At last count, the factor Xa inhibitor was being prescribed more than 2.5 million times a year in the United States, with more growth on the horizon. However, the drug has also been marred in thousands of claims of injury and death from bleeding, and named in a new mass-tort lawsuit.
Since April, when the FDA opened an investigation into the safety of power morcellators used in more than 60,000 yearly hysterectomies and myomectomies, consumer advocates have been waiting to see if the agency would ban their use.
Today, FDA officials answered those questions with a harsh warning against use of the devices, but stopped short of issuing a full ban.