Xeljanz is a popular medication that is prescribed to treat patients suffering from rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. Xeljanz is the brand name for the drug Tofacitinib, which works by suppressing the patient’s immune system to help reduce inflammation in the body. Since its original release in 2012, this medication has exploded in popularity due to its placement of ads on television and in magazines.
Manufactured by pharmaceutical giant Pfizer, the company has raked in over a billion dollars in profit off the hundreds of thousands of people use the drug. In February 2019, Pfizer was hit with an FDA safety warning that linked Xeljanz to an increased risk of blood clots in the lungs and overall death. This has led to many lawyers, including us, to investigate potential Zeljanz lawsuits.
Months later, this forced Pfizer to put a black box warning on their drug label. This scares off doctors and patients. This is arguably why Pfizer did not suggest to the FDA adding this warning long ago. This warning is expected to put significant stress on the company’s profits as patients avoid the medication and file new failure to warn lawsuits. (The good news for Pfizer is that there warning will prevent many future lawsuits from being filed.)
What is Xeljanz?
Xeljanz is an oral medication that was originally developed to treat moderate to severe rheumatoid arthritis, however, since its release it has also been approved to treat psoriatic arthritis and ulcerative colitis. Pfizer first released Xeljanz onto the public market in 2012 after receiving FDA approval. Soon after the release, the company embarked on an intense mass marketing campaign to bring attention to their new drug. Pfizer invested in various types of advertisements, including on TV, in magazines, and on billboards.
The campaign was highly effective, and patients all around the country became interested in trying out the medication. They had a reason to be excited, too. Xeljanz is one of only two JAK inhibitor drugs (a class of medications that compresses the immune system) that have been approved to treat rheumatoid arthritis. It opened a new door for patients who did not respond well to methotrexate, another standard treatment for arthritis and colitis conditions.
In recent years, Pfizer’s success has only continued to grow. Between 2013 to 2018, doctors prescribed Xeljanz to around 132,000 people in the United States for rheumatoid arthritis. On top of that, Xeljanz is now approved in over 80 countries, drastically increasing Pfizer’s profits. In 2018 alone, the company brought in almost $2 billion dollars worldwide. It’s fair to say that Pfizer and Xeljanz have been dominating the pharmaceutical market.
How Is Xeljanz Used?
Xeljanz comes in two forms: Xeljanz instant-release and Xeljanz XR (extended-release). Both forms of Xeljanz contain the ingredient known as tofacitinib, which belongs to a class of drugs called JAK inhibitors. JAK inhibitors work by blocking the immune system’s ability to produce cytokine, a protein that plays a role in inflammation. This allows the immune system to calm down and help reduce swelling in the body. There are two dosages for Xeljanz, a 5mg or 11mg pill taken once or twice a day depending on the patient’s condition.
FDA Safety Warnings
In 2019, things began to go downhill for Pfizer when the FDA started to crack down on the safety of Xeljanz. The pushback came in February when the FDA published results from a clinical study that found a link between Xeljanz usage and an increased risk of blood clots in the lungs, known as pulmonary embolisms, and overall death in patients.
Back in 2012 when the FDA first approved Xeljanz for the public market, they also required a clinical trial to study the risk of heart-related events, cancer, and opportunistic infections for the 5mg and 11mg doses. They compared the treatment and risk factors of Xeljanz to another popular inhibitor drug that is often sold under the brand names of Humira, Remicade, and Enbrel.
The trial used subjects at least 50 years old and had at least one cardiovascular risk factor. Before the study could even be completed, researchers identified dangerous and possibly life-threatening side-effects of Xeljanz, which resulted in the FDA quickly publishing a safety warning for the medication.
The results of the study found that patients who are prescribed the highest dose of Xeljanz, 11mg taken twice a day, are at a significantly increased risk of pulmonary embolism (PE), deep-vein thrombosis (DVT), and death compared to the lower 5mg dose. PE and DVT are blood clots that can develop in a person’s legs. Blood clots by themselves can be dangerous, but the real problem is when the clots grow big enough to break off in the body and travel to other organs. With PE and PVT, the clot travels to the lungs and becomes stuck in an artery, blocking the passage of blood and oxygen. This creates a life-threatening situation that can be fatal if a person does not receive medical treatment in time.
The FDA continued its investigation into Xeljanz’s side effects over the next few months, but it wasn’t long until another statement was released. In July, the FDA approved a black box warning for Xeljanz, the strictest warning for drug labels in the US. Medications only receive black box warnings when there is reasonable evidence of a drug being associated with severe, life-altering side effects. This is the latest update of the Xeljanz investigation, but most likely not the last.
Xeljanz Blood Clot Lawsuits
Following the release of the safety warning in February, Pfizer immediately began to feel the repercussions of the study’s findings. Patients became outraged with the company and doctors began to avoid prescribing Xeljanz due to bad publicity. It’s expected that there will be a dramatic increase in Xeljanz-related lawsuits within the next year, which has the potential of putting a serious dent into Pfizer’s profits from being forced to shell out large sums of settlement money.
These new lawsuits will center on the fact that Xeljanz’s drug label did not include blood clots as a potential side-effect until the FDA required it in July 2019. Patients took this medication for years without knowing the real effects it could have. This might meet the requirements for a “failure to warn” case, meaning Pfizer did not provide a clear warning or set of instructions for the proper use of their medication.
To prove this case, one of the key components is showing that Pfizer was aware of the dangerous side effects but sold it anyway. Patients filing lawsuits believe they may have some evidence to support this claim. Before the FDA released its first safety warning, there were already reports submitted to the FDA Adverse Event Reporting System (FAERS) by people saying they experienced PE or DVT while taking Xeljanz.
Despite the growing amount of reports, Pfizer continuously denied the connection and refused to take action to investigate further. It wasn’t until the FDA’s report that Pfizer agreed to start transitioning patients onto lower doses. Some of these outraged patients believe that Pfizer already knew there was an ongoing issue with their medication but intentionally refused to address the problem out of fear it would hurt their business.
Patients seeking to hold Pfizer liable for their injuries will most likely need to show:
- That they were being treated for arthritis or ulcerative colitis with Xeljanz or Xeljanz XR
- That they were prescribed a 11mg twice daily dosage
- They suffered from PE, DVT, or other serious blood clot injuries
The outlook for Pfizer and Xeljanz can be both good and bad. The good news is that with the black box warning, newly injured patients will find it hard to file suit based on failure to warn claims. This means that there will eventually be an end to Xeljanz-related lawsuits. The bad news is that Pfizer has already lost a significant amount of support from both doctors and patients. Additionally, there may be future safety warnings released once there are final results from ongoing clinical trials.
Hiring a Xeljanz Lawyer
If you believe you may have a Xeljanz claim, get a free online consultation. We can tell you if we think you have a case and what your options are. There is no cost or commitment to you.