Every year, pharmaceutical companies and healthcare experts create various new prescription drugs to treat a host of diseases and conditions. After they have gone through a lengthy and arduous approval process by the U.S. Food and Drug Administration (FDA), they can enter the market where doctors and other qualified personnel can prescribe them to patients.

During the approval process, the drug manufacturer will provide the FDA with all know risks that they discovered. After all, all prescription drugs come with inherent risks. The FDA will then ensure that the health benefits do outweigh these risks before they approve the drug for distribution. They will make sure no dishonest practice went into creating the medication and will provide doctors and patients with appropriate information regarding safe usage.

In most cases, the FDA will run further testing to look for any other issues, as was the case with Xeljanz. In this case, however, the FDA recently released the results of their interim analysis on Xeljanz, which uncovered that taking a twice-daily 10mg dose of tofacitinib (the active ingredient in Xeljanz) led to an increased risk of blood clots and death. Naturally, this discovery has led to a host of dangerous drug lawsuits against Pfizer (Xeljanz’ manufacturer).

Today, we are going to take a closer look at the FDA’s interim analysis to create a better understanding of their process and how they discovered these underlying issues of taking Xeljanz.

FDA’s Approval

The FDA first approved Xeljanz as a treatment for moderate to severe cases of rheumatoid arthritis (RA) back in 2012. Over time, they also approved Xeljanz as a treatment for psoriatic arthritis (PA) and ulcerative colitis (UC) in 2017 and 2018, respectively. Each condition affects the body in similar ways, so it makes sense why the FDA would approve Xeljanz as a treatment option for each.

However, in the time of its approval, more and more cases of adverse reactions have emerged, with many people filing Xeljanz lawsuits against Pfizer. Since the FDA’s approval for each condition, they have released the findings of their interim analysis on Xeljanz, which shined a light on some unknown reactions of the drug.

The FDA’s Safety Announcement

In early 2019, the FDA released a safety announcement warning the public that a safety trial they had conducted found an increased risk of blood clots and even death. They noted that this increased risk occurred in patients that were taking a 10mg twice daily dose of tofacitinib to treat rheumatoid arthritis.

However, the FDA made it clear that it had not approved a 10mg twice daily dose of tofacitinib for RA. The organization had only approved this dose for use in treating patients living with ulcerative colitis. Since this discovery, Pfizer has been transitioning patients from this high 10mg dose to a currently approved 5mg dose.

The FDA began this ongoing clinical trial when they first approved Xeljanz for RA back in 2012. This trial was still ongoing throughout 2019, with the goal of uncovering any other concerns.

By July 2019, the FDA had officially approved new safety warnings about the increased risks. They also added their most prominent Black Boxed Warning after reviewing the data from the FDA’s interim analysis.

The FDA’s Interim Analysis

When the FDA approved Xeljanz for RA, they required another study to evaluate patients’ risk of heart-related events, cancer, and infections. This longitudinal study continued into 2019 when the FDA released their findings to the public.

The FDA had only approved this dosage for patients with ulcerative colitis. Now, they’ve limited this 10mg dose to certain patients that experience severe side effects or are not treated effectively by other prescriptions. Furthermore, the FDA did not approve this dose as a treatment for either rheumatoid arthritis or psoriatic arthritis.

The trial evaluated the risk of heart-related events, cancer, and infections in RA patients on background methotrexate. It studied two doses of tofacitinib: 5mg twice daily (approved for RA treatment) and a higher 10mg twice daily dose. They compared these doses with a TNF blocker. As we have mentioned already, these findings revealed an increased risk of blood clots and death when taking a twice-daily 10mg dose of tofacitinib compared to those taking the 5mg dose or a TNF blocker.

As of January 2019, the results of the FDA’s interim analysis are as followed:

  • There were 19 cases of blood clots in the lung out of 3,884 patient-years of follow-up for those taking a 10mg twice daily dose of tofacitinib, compared to only 3 cases out of 3,982 patient-years for those taking TNF blockers.
  • There were 45 cases of death from all causes out of 3,884 patient-years of follow-up for those taking a 10mg twice daily dose of tofacitinib, compared to just 25 cases out of 3,982 patient-years for those taking TNF blockers.

Due to the results of the FDA’s interim analysis, Pfizer has stopped 10mg twice daily treatments. They did keep allowing patients to use the 5mg twice daily dose.

The FDA’s Advice

When the FDA released these findings, they also provided advice to both patients and healthcare providers to protect them. Their advice included:

  • Patients: Before taking Xeljanz, tell your doctor if you have a history of blood clots or heart disease, expressing any questions or concerns. Do not stop taking the drug without first consulting with your healthcare professional. Doing so could make your condition worse. Seek medical attention if you experience any of these symptoms:
    • Sudden shortness of breath
    • Chest pain that worsens when breathing
    • Leg or arm swelling
    • Leg pain or tenderness
    • If the skin on the painful or swollen limb is red or discolored
  • Healthcare Professionals: Discontinue tofacitinib and exam patients that show signs of thrombosis. Advise patients about the risks and to seek medical attention immediately if they experience unusual symptoms (as listed above). Avoid prescribing Xeljanz to patients with a high risk of blood clots. Reserve this drug only for UC patients that did not respond well to TNF blockers. Use the lowest effective dose of tofacitinib, limiting the use of 10mg twice daily dose to the shortest period possible.

Quickly after the FDA released their findings, countless Xeljanz lawsuits emerged seeking compensation for damages sustained. The adverse reactions of Xeljanz can be life-threatening. Due to the circumstances of these injuries, those who experienced injuries can seek compensation. If you or someone you loved suffered from the adverse reactions of Xeljanz, contact Wormington & Bollinger to learn how we can help you.