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Xarelto: Its Greatest Benefits and Worst Threats


Rivaroxaban is a popular anti-coagulant drug that was approved by the US Food and Drug Administration (FDA) in July 2011 for people suffering from: atrial fibrillation (an irregularity in heart beat); deep vein thrombosis (DVT), also known as deep venous thrombosis, which refers to the formation of blood clots (or thrombus) in deep veins, mainly in the legs; and, pulmonary embolism, which is blood clot in the lungs. It is mainly intended to prevent harmful blood clots from forming, avoid chances of blood clots from recurring and reduce possible risks of stroke in people who have just undergone surgery for total hip replacement or knee replacement. In the US, and in some other countries, Rivaroxaban is sold under the generic name Xarelto and it is jointly produced by Janssen Pharmaceuticals (a Johnson & Johnson subsidiary) and Bayer Health Care.

Xarelto is a new generation blood thinner that is formulated to act as a direct thrombin inhibitor (DTI), to block thrombin from ever forming (thrombin are blood plasma enzymes that cause the blood to clot). Like Pradaxa, another DTI that was approved by the FDA in 2010 and which Xarelto was intended to compete against, Xarelto has been highly commended by pharmaceutical companies and doctors due to its formulation that no longer necessitates frequent testing of blood or diet and exercise monitoring which Warfarin, the anticoagulant drug that has dominated the market since 1954, requires.

Unlike Pradaxa, however, which directly blocks the production of thrombin, Xarelto directly attacks and inhibits the production of Factor Xa, the protein necessary in thrombin formation. Furthermore, Xarelto has been proven as very effective in the:

  • Reduction of risks of stroke in non-valvular atrial fibulation
  • Treatment of pulmonary embolism (PE) and deep vein thrombosis (DVT)
  • Prevention of DVT following a knee replacement or hip replacement surgery
  • Reduction of DVT and PE recurrence

Despite its effectivity, Xarelto was discovered as not without adverse effects, some of which even fatal, thus, enough reason for the FDA to mandate a black box warning label to the drug’s packaging. One agency that keeps track of problematic or defective drugs is the Institution for Safe Medication Practices (ISMP), a nonprofit consumer watchdog organization. Based on ISMP data Xarelto’s adverse effects, which thousands of patients have already complained of, include: internal bleeding (including bleeding in the abdomen, intestines and rectum); blood clots; epidural or spinal hematomas (a condition wherein blood collects outside the blood vessels in the spinal cord area – this increases the risk of permanent paralysis); brain hemorrhaging; uncontrollable bleeding (to which there is no known remedy); blood in the urine and/or stool; severe nosebleeds; vomiting of, and coughing up, blood; stroke; and, risk of heart problems following discontinuation.

Millions of patients had already been prescribed with Xarelto despite its being new in the market. In fact, currently, Xarelto is the number one blood thinning medication in the US. But (in 2012) even before topping market sales (where blood thinning drugs are concerned) about 2081 serious adverse events (151 of these were fatal) had already been reported to the FDA.

It is hard to say exactly how many lawsuits have already been filed against the manufacturers of Xarelto as the lawsuits are based on different issues, like wrongful death, brain hemorrhaging, uncontrolled bleeding, and so forth.

“Keyhole” Surgery Leads to Surgical Injuries


Minimally invasive surgical methods, or keyhole surgeries, are the preferred ones when confronted with the need for a procedure, mostly because healing times are faster and there is a lower risk of excessive blood loss. Laparoscopy, which uses cameras inserted into small incisions in the abdomen, was one of the earliest and most popular of these methods, and it is still being used today.

A relatively recent entrant in the field which has grabbed a substantial share in the market since its introduction 13 years ago is the da Vinci Surgical System, which is a robot-assisted surgical method. Recent events, however, has served to somewhat tarnish the reputation of the metallic automaton in the field of surgical instruments.

At least 70 deaths have been directly linked to the use of the da Vinci robot, landing its manufacturer Intuitive Surgical Inc. in legal hot water and affecting its standing in the market. More adverse events have been reported, and some studies say underreported with the machine’s use, prompting the Food and Drug Administration (FDA) to launch an investigation to determine the extent to which the da Vinci robot may be said to have directly caused unnecessary surgical injuries. And now, Intuitive itself has issued a statement regarding defects in certain components of the system which may inadvertently cause even more damage to the patients.

Intuitive sent Urgent Medical Device Notification in May 2013 to those who purchased the da Vinci system regarding potential problems with the Monopolar Curved Scissors (MCS), commonly called the Hot Shears. Micro-cracks along the shaft that developed when the shears were reprocessed, maintenance performed on all instruments periodically after a certain number of procedures done. These micro-cracks may allow electric current to “arc” from the instrument to living tissue, possibly causing burns and tissue damage. Less than a year ago, the tips of the scissors had been recalled, but Intuitive does not confirm that these defects caused injury to any patient.

The initiatives were classified as part of the company’s efforts to improve the products, and had nothing to do with the surgical injury lawsuits already filed against it. Taken one by one, these adverse events may be said to be part and parcel of the risks associated with surgery, but taken together, they represent a serious problem with the technology.

Defective Air Bag: Cause of Injury rather than a Device for Safety


A research conducted by the National Highway Traffic Safety Administration (NHTSA) shows the top four causes of death in car-related accidents: drunk-driving; speeding; distracted driving; and, bad weather. In all four causes, the research also showed that those who suffered the severest injuries and those who died on the spot of the accident were either drivers or passengers who were not wearing a seatbelt.

While seatbelts remain thus far the best devices for restraining vehicle driver and passengers, saving them from impacts and crashes that can either severely injure them or cause their untimely death, another device, which is a perfect supplement to seatbelts has been introduced – the air bag, also known as Federal Motor Vehicle Safety Standard 208 or FMVSS 208.

Designed as a vehicle safety device, air bags provide a cushion between the occupants and solid objects inside the car, like the windows, the dash board and the steering wheel and, thus, lessen the possibility of crash injuries. These are made from flexible nylon fabric, folded into the steering wheel, dashboard and other areas of the car, and are connected to a sensor which makes them inflate quickly during moderate or severe collisions.

The use of car air bags was first introduced by Ford in 1971; General Motors followed suit in 1973, incorporating the air bag in their Chevrolets. It was not until July 11, 1984, however, when the U.S. government mandated that cars manufactured after April 1, 1989, ought to be equipped with a passive restraint, such as a seat belt or an air bag and, through the motivation of the U.S. National Highway Traffic Safety Administration, this same mandate was applied on light trucks beginning in 1997.

The 2,788 lives saved because of air bags only show that the device is effective. However, one cannot simply dismiss reports on how some air bags have malfunctioned or never functioned at all, causing severe injuries or death instead of protecting and saving a life.

Aware of automobile defects, the website of Habush & Rottier, S.C., indicates the three top reasons how air bags can cause injuries:

  • Air bags inflating even when there is no collision
  • Inflating ahead of time and then immediately deflating, failing to provide the needed cushion during actual impact
  • Late deployment

The possible reasons behind these malfunctions can be a flaw in the design, a manufacturing defect, incorrect assembly or installation, improper folding, overpowered inflators, venting problems or inaccurate software. Some of the injuries defective air bags can cause can include broken bones, head injury, traumatic brain injury and chemical burns.

Knowing your rights, when accidents occur due to a defective air bag inside your vehicle, is highly important; and who else, other than a truly knowledgeable lawyer, can explain to you the law and what it says regarding your legal rights? It the event of an accident, make sure you have an automobile defect lawyer on your side.