As we have spoken about in previous blogs, the U.S. Food and Drug Administration (FDA) approved the prescription drug Xeljanz as a treatment for rheumatoid arthritis in 2012. They eventually approved its use for psoriatic arthritis in 2017 and ulcerative colitis in 2018.

However, in the years since its release, cases of Xeljanz leading to adverse reactions have popped up around the country. For some patients taking the drug, they experienced dangerous, potentially life-threatening reactions, such as blood clots. These reactions were not advertised by prescribing doctors nor on the label.

In 2019, the FDA released a safety announcement detailing findings they uncovered during an interim analysis of a study conducted in 2012. The study discovered that patients taking a 10mg dose of tofacitinib (the active ingredient in Xeljanz) twice a day had an increased risk of blood clots and death.

Since this discovery, the FDA stopped all 10mg prescriptions of the drug while also approving a black box warning label detailing the increased risks. However, many patients have already experienced these adverse reactions, leading many patients to file lawsuits. But, how do you know when to file a Xeljanz lawsuit?

Healthcare experts and scientists design prescription drugs to aid those suffering from a host of illnesses and conditions. While they come with inherent risks, their medical benefits often outweigh their side effects.

When a prescription proves to be more of a risk than initially thought, as is the case with Xeljanz, lives are at risk. If you or someone you love suffered injuries after taking Xeljanz, contact Wormington & Bollinger and let us fight for the justice you deserve.

Xeljanz’s Adverse Reactions

In the years following the FDA’s approval of Xeljanz, more cases of dangerous side effects have emerged. While the FDA had already confirmed many side effects, they have since discovered the existence of more.

In the FDA’s safety announcement released in 2019, they announced that taking a 10mg dose of tofacitinib increased your risk of blood clots and death. As of January 2019, the FDA’s interim results have found:

• 19 cases of blood clots in the lungs of those taking a 10mg dose of tofacitinib twice a day
• 45 cases of death of those taking a 10mg dose of tofacitinib twice a day

There are two types of blood clots that Xeljanz causes: pulmonary embolism (PE) and deep vein thrombosis (DVT). PE occurs when there are blood clots in the lungs, while DVT is when blood clots most commonly occur in the thighs and lower legs. Both are dangerous and potentially life-threatening.

There is proof that Pfizer (Xeljanz’s manufacturer) knew of these risks. In 2013, the Committee for Medicinal Products in Europe declined the approval of Xeljanz for rheumatoid arthritis. Their studies showed that while the 5mg dose was safe, the 10mg dose was not.

The committee advised Pfizer about these findings and advise patients not to take the drug at a higher dosage, but Pfizer did not communicate these findings to American patients.

Filing a Xeljanz Lawsuit

Following the FDA’s statement release, Pfizer quickly felt the repercussions of the findings. Many doctors quit prescribing the drug to avoid bad publicity, and many patients were outraged due to unforeseen side effects. Xeljanz lawsuits quickly emerged, with many more expected.

Most of these lawsuits focused on the fact that Pfizer did not include a warning on the label detailing blood clots as a potential side effect until after the FDA required them to in July 2019.

If you have been taking Xeljanz for an extended period and suffered these injuries after taking this drug, you may be able to file a lawsuit.

When filing a dangerous drug claim, there are three categories to do so in, which are:

• Defective Designs: When a drug is unreasonably dangerous even when a patient uses it as intended, a defect in its design or formula could be to blame.
• Manufacturing Defects: Some dangerous drug cases involve drugs that are safely designed, but an issue occurred during manufacturing. Often, a contaminant is to blame for these defects.
• Inaccurate Marketing: All drugs must come with warning labels that remind patients and doctors of any dangerous side effects. When there is no label or the label is misleading and does not highlight the risk adequately, you can file a lawsuit.

Legal Grounds

In the case of Pfizer and Xeljanz, patients have filed lawsuits on two grounds.

Many have filed a Xeljanz Lawsuit on the grounds that Pfizer improperly designed the drug, indicating that Pfizer was aware of the dangers and did not make an effort to update or remove the issues that led to these side effects.

These lawsuits argue that Pfizer should be liable for its negligence when designing and creating Xeljanz. They aim to hold Pfizer responsible for their negligence for all injuries caused by this drug.

Additionally, many lawsuits have also claimed that Pfizer failed to warn doctors and patients about the risks of the drug. While other side effects were listed, blood clots were not included until July 2019.

Doctors rely on the safety information about a drug from pharmaceutical companies to help them understand the benefits and dangers of a prescription. Without complete information, they cannot relay the real risks specific drugs present to patients.

For patients, they need this information to make informed decisions about whether to take a medication or not. Patients cannot make an informed decision without all of the necessary details. In many Xeljanz lawsuits, they claim that Pfizer downplayed or left out the risks of the medication’s side effects.

In both design defect lawsuits and inaccurate marketing lawsuits, dangerous drug attorneys argue that Pfizer is liable for the damage.

Contact a Dangerous Drug Attorney

Patients rely on prescription drugs to help treat their medical condition or illness. Often, these drugs do just that. While they do contain side effects, the medical benefits often outweigh the risks. Unfortunately, that is not the case for every drug, as in the cases of Xeljanz.

If you were prescribed Xeljanz and suffered injuries and damages because of this drug, contact the dangerous drug attorneys at Wormington & Bollinger. We will help guide your Xeljanz lawsuit to ensure you receive the compensation you deserve.