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.
Johnson & Johnson’s novel blood thinning drug Xarelto has been on a meteoric rise since its introduction in 2011. In recent years, it has racked up additional FDA approvals and eclipsed both competitors Eliquis and Pradaxa in sales.
The doctor leading the charge against the use of power morcellator devices for hysterectomies and myomectomies says the FDA is likely to add restrictions, but will not ban their use.
Dr. Hooman Noorchashm, a cardiac surgeon, began a full-time effort last fall to bring the dangers of the surgical devices to light after his wife, anesthesiologist Dr. Amy Reed, developed accelerated uterine cancer following a laparoscopic fibroid removal.
Most people recognize prescription drugs only by the brand names they see in advertisements each day. However, did you know that approximately 75% of the medications taken in the United States every year are generic?
And, with increasing pressure by insurance companies and changing healthcare laws, more and more people could be forced to switch from brand name meds to cheaper generics.
A growing number of patients who’ve filed lawsuits against Bayer and Johnson & Johnson alleging their popular blood thinner Xarelto caused uncontrollable internal bleeding will soon know how and where their cases will be handled.
Last week, the Judicial Panel on Multidistrict Litigation, or JPML, issued their latest hearing order indicating the panel will hear arguments over Xarelto product liability claims at their next session on December 4th in Charleston, South Carolina.
This month, Senator Robert Casey Jr. from Pennsylvania became the latest member of Congress to draft a letter to the FDA expressing concern about the continued use of power morcellators for hysterectomies and fibroid removal surgeries.
The oversight is a welcome sign after a year in which the machines have been linked to spreading deadly uterine cancer in numerous patients. However, Senator Casey is only the third member to take the initiative to protect the public in this way.
The European Medicines Agency, or EMA, came out this week in support of testosterone replacement therapy (TRT) drugs, but recommended they only be used in limited circumstances by those who actually need them.
The agency indicated the benefits of TRT drugs still outweigh the risks, but stated patients should be tested for hypogonadism, or low testosterone levels, before they are prescribed.
A new study from the University of Illinois in Chicago has established a link between popular testosterone replacement therapy (TRT) drugs and prostate cancer.
And, although additional testing is needed on humans, these early indications are troubling with the increasing use of these medications by millions of men each year.
Contraceptive methods are a uniquely personal choice for women. After testing different brands for compatibility and side effects, most become fiercely loyal to their favorite.
Although the use of patches, rings, IUDs and injections is on the rise in the past decade, the traditional birth control pill is still the most common form of prescription birth control. However, these come with risks.