In February 2019, the U.S. Food and Drug Administration (FDA) released a Drug Safety Communication statement that announced the discovery of an increased risk of blood clots and death in those taking Xeljanz. Since then, the pharmaceutical company that manufactures Xeljanz (Pfizer) has come under fire.

Countless dangerous drug lawsuits have emerged since the release of the FDA’s findings, which have sent Pfizer reeling. Many of these lawsuits claim Pfizer did not design the drug correctly, failed to manufacture it safely, or failed to inform the public of the complete list of dangers.

Regardless of if Pfizer was aware of these adverse reactions or not, they still put countless lives at risk. The FDA first approved Xeljanz as a treatment for rheumatoid arthritis in 2012. Since then, thousands of patients have taken the drug. That means that thousands of people are also at risk.

Since 2012, the FDA has also approved Xeljanz as a treatment for psoriatic arthritis and ulcerative colitis in later years. As more and more lawsuits emerge, it’s vital to understand the drug in question. What many people do not realize is that there are two forms of this prescription drug: Xeljanz and Xeljanz XR. Both can lead to severe side effects.

If you or someone you loved suffered an injury while taking either Xeljanz or Xeljanz XR, contact the dangerous drug attorneys at Wormington & Bollinger. We will fight tirelessly to ensure you receive the justice and compensation you deserve.

How Xeljanz/Xeljanz XR Work 

As we mentioned earlier, Pfizer manufactured two versions of this drug: Xeljanz and Xeljanz XR. They both treat the same condition, operating in similar ways. They both have virtually the same effects on your body.

The conditions this drug treats each have an overactive immune system. Normally, a healthy immune system will attack foreign substances that enter the body, such as viruses and bacteria, to keep you safe. For those with these conditions, however, their immune system kicks in even when there is no threat.

It begins to attack healthy cells and tissue that leads to inflammation in the joints and tissues, causing pain and reduced function. In cases of rheumatoid arthritis, patients have an excess of a protein called cytokines. This protein helps control your immune system. When you have an infection, your body produces more of them. However, too much of this protein causes inflammation.

The active ingredient in Xeljanz is tofacitinib, which falls under a class of drugs known as Janus kinase inhibitors (JAK inhibitors). JAK inhibitors disrupt the body’s production of more cytokines by blocking the message pathways. This disruption calms the immune system down, which prevents inflammation.

It is crucial to note that suppressing the immune system this way also puts you at a greater risk of suffering an infection. The immune system does not respond as effectively to bacterial, mycobacterial, fungal, or viral infections.

Xeljanz vs. Xeljanz XR

Both forms of Xeljanz have tofacitinib in them, so they affect the body the same way. However, there are some differences between the two that you should know.

Regular Xeljanz is taken twice a day and comes in a 5mg dose (it did come in 10mg doses, but doctors no longer prescribe that dose after the FDA’s finding). This drug is an immediate release, releasing into your bloodstream over the course of several hours. It begins working almost as soon as you start taking it. Since it is taken twice a day, take the doses about 12 hours apart. You can take the drug with or without food. You can crush, split, or chew regular Xeljanz.

Xeljanz XR is an extended-release drug, meaning it takes longer to work. It releases into your bloodstream over the entire day. You only need to take an 11mg dose once a day. While you can take it any time of the day, try taking it at the same time every day. As with regular Xeljanz, you can take Xeljanz XR with or without food. However, unlike regular Xeljanz, you cannot crush, split, or chew Xeljanz XR. You need to swallow them whole.

If you struggle with swallowing pills, reach out to your doctor. They will help you find an easier way for you to swallow pills.

There is no clear distinction between when you should take one over the other. Both have the same effects.

Adverse Reactions 

As we mentioned earlier, the FDA released a statement detailing the findings of an interim analysis of a study they started in 2012 when they first approved Xeljanz. In their results, they discovered that patients that took a twice-daily 10mg dose of the drug were at an increased risk of blood clots and death.

Pulmonary embolism (PE) (blood clots in lungs) and deep vein thrombosis (DVT) (blood clots in thighs and lower legs) are the two blood clots associated with Xeljanz. Since these results emerged, doctors no longer prescribe 10mg doses of Xeljanz for rheumatoid arthritis or psoriatic arthritis. It can only be used for ulcerative colitis in limited situations.

The FDA also added a more prominent black box warning detailing the increased risk of blood clots and death.

Pfizer released a statement shortly after the FDA released its own. In its statement, the pharmaceutical company discussed the FDA’s findings and the changes in approved doses. They also discussed the potential adverse reactions the FDA unearthed.

Contact a Xeljanz Attorney

Since these findings became public, countless individuals who were taking Xeljanz have filed Xeljanz lawsuits. People are seeking damages for injuries they suffered while taking the drug (such as for current and future medical expenses, loss of wages, pain and suffering, and more).

Because you have to deal with a pharmaceutical company, these cases are often complicated, which is why you need a trusted and experienced dangerous drug attorney to help you receive the compensation you deserve. If you or a loved one suffered adverse side effects after taking Xeljanz/Xeljanz XR, contact Wormington & Bollinger and let us fight for you.