Since the start of 2019, the controversy surrounding a drug referred to as Xeljanz has been hotly debated.  Many users want to know more about the drug, its side effects, and what purports the Xeljanz lawsuit. Before I can go any further, I would like to give more details about this drug and why it's considered unsafe for human health.

Xeljanz, or in other terms tofacitinib, is a drug that was initially approved by the FDA back in 2012 to treat rheumatoid arthritis. Rheumatoid arthritis is a chronic health condition that affects a small percentage of the population resulting in inflammation and pain in the joints. Later on, in 2017, the FDA also approved the use of Xeljanz XR and Xeljanz to treat active psoriatic arthritis. The drug was also thought to be effective for the treatment of active ulcerative colitis. FDA gave this approval in May 2018.

From all this, there is no doubt Xeljanz was quite a popular drug, and thousands of Americans must have used it by now. Pfizer incorporation is the manufacturer of this infamous drug and has allegedly made nearly $1.7 billion in 2018 alone. Normally, people who have rheumatoid arthritis have to deal with excruciating pain and stiffness in their joints. Therefore, you would expect many were eager and happy to get relief from the disturbing symptoms.

How do the drugs Xeljanz and Xeljanz XR work?

As I have earlier mentioned, Xeljanz was approved for the treatment of rheumatoid arthritis, psoriasis, and ulcerative colitis. The drug basically slows down the JAK enzymes, which are responsible for the growth of new cells in the body. Any interference with the normal process results in extra tissue growth, which in turn hinders the proper development of bone structure and cartilages in the joints. 

The pain and inflammation are brought about when the body's immune system tackles the extra tissue as a threat. Slowing down the enzymes works to prevent this condition.

What is the drug administration and dosing?

The Xeljanz drug is administered in pill form as opposed to the other rheumatoid arthritis treatments that involved injections.  There are two recommended doses;

• Xeljanz-the arthritis patients take only 5 milligrams in a day.

• Xeljanz XR- this is meant for extended-release. The dosage consists of 11-milligram pills that work to slow down the release of the drug. It's taken only once in a day.

For most patients with arthritis, the required dosage was supposed to be 5 milligrams per day. However, there are claims Pfizer had already marketing the drug at double its dosage. Verily, there are doctors who had already started prescribing stronger doses to their patients and this is where the problem occurred.

What exactly is the Xeljanz lawsuit?

When talking about Xeljanz lawsuits, I am simply referring to legal claims against Pfizer filed by the patients who used the drug and suffered complications or serious side effects.

People who have arthritis have been using this drug for several years now. With that said, at the beginning of 2019, the FDA issued a safety alert warning people of adverse effects such as the high risk of blood clots and even death. According to the FDA report, patients taking the 10 mg dosage twice of either Xeljanz or Xeljanz XR were more prone to the adverse side effects.

Typically, every drug that receives FDA approval has to undergo clinical trials. In this case, Pfizer had ongoing clinical trials on Xeljanz, but it was not until 2019 that the manufacturer warned patients against taking 10 mg doses for the arthritis treatment. At this time, Pfizer issued a statement saying it was re-evaluating the drug dosage recommendations.  Pfizer noted that many of the study participants who were put on a 10 mg dose of Xeljanz twice daily had quite a high risk of developing blood clots in their lungs as well as suffering pulmonary embolism. In July the same year, FDA issued Pfizer with a new black box warning on Xeljanz.