The U.S. Food and Drug Administration (FDA) initially approved Xeljanz as a treatment option for those with rheumatoid arthritis (RA) in 2012. Over the years, the FDA approved the drug as a treatment for psoriatic arthritis (PA) and ulcerative colitis (UC) in 2017 and 2018, respectively. However, in the years since its approval, more cases of adverse reactions of Xeljanz have emerged.
Furthermore, in early 2019, the FDA released the findings of their interim analysis, which found that taking a twice-daily 10mg dose of tofacitinib (the active ingredient in Xeljanz) increased your risk of blood clots and death. In response, the FDA included their most prominent black box warning to alert doctors and patients about these dangers.
However, because tofacitinib belongs to a class of drugs known as JAK inhibitors, many patients that take other JAK inhibitors worry about whether or not their prescription will lead to the same adverse reactions as Xeljanz. The FDA’s interim analysis is still new, so whether these safety concerns translate remains to be seen.
Wormington & Bollinger have years of experience handling dangerous drug cases, which gives us an advantage when handling your Xeljanz lawsuit. If you or someone you love suffered injuries due to the adverse reactions of Xeljanz, contact our dangerous drug law firm today.
What are JAK Inhibitors?
Janus kinase (JAK) inhibitors are common treatments doctors prescribe to patients with rheumatoid arthritis. The goal of the drug is to reduce the inflammation and swelling in the joints while relieving joint pain. JAK inhibitors belong to a family of medications known as disease-modifying antirheumatic drugs (DMARDs).
Those living with RA, PA, and UC all suffer from an overactive immune system. Your body produces proteins called cytokines to help manage your immune system. Whenever it detects an infection, it increases the production of cytokines to fight the infection.
For those living with RA, however, their bodies produce far more cytokines than necessary, which leads to inflammation and pain. When these proteins enter your body, they attach to receptors on immune cells. Once attached, they send a message to produce more cytokines, which increases inflammation.
JAK inhibitors disrupt this process by blocking the message pathways, preventing more cytokines from being made. These inhibitors calm the immune system, thus reducing inflammation and relieving pain. That is how Xeljanz works and treats RA, as well as PA and UC.
Unfortunately, because JAK inhibitors do impact your immune system, it does leave your body more susceptible to infections. These drugs decrease your body’s ability to fight back against bacterial, mycobacterial, fungal, and viral infections. That is why some of the side effects Pfizer (Xeljanz’s manufacturer) informed the FDA about include upper respiratory infections, shingles, and more.
Do Other JAK Inhibitors Share the Same Safety Risks as Xeljanz?
Because the status of the FDA’s interim analysis is still ongoing, it would be too early to say whether all JAK inhibitors share the same safety concerns as Xeljanz. However, it is vital to note that Xeljanz is not the first JAK inhibitor to run into such issues.
In April 2017, the FDA denied approval to Eli Lilly’s Olumiant (another RA drug) due to concerns about its safety risks. The FDA needed more clinical data to ensure that they approved the appropriate doses and to distinguish the safety concerns better. Eventually, the FDA did approve the drug in the summer of 2018, only approving the lower dose. They also included a black box warning for blood clots.
In August 2019, drug manufacturer Abbvie secured FDA approval for its “supposedly safer JAK inhibitor, upadacitinib.” However, this approval came after a long process that involved a hemorrhagic stroke death and a pulmonary embolism (which the manufacturer said occurred in patients with “pre-existing cardiovascular risk factors”). The FDA did approve upadacitinib, but they did include a black box warning for thrombosis, just like Olumiant and Xeljanz. The approved dose was also lower.
Future JAK inhibitors look to run into some trouble due to the risks each drug before it has faced. Experts expect all JAK inhibitors in the future to carry similar warnings to the ones we have already seen.
It is vital to note that these warnings are for higher doses of these drugs. After the FDA’s safety statement, Pfizer has been transitioning patients from a 10mg twice-daily dose of Xeljanz to a lower 5mg dose. Other drugs were never even approved for higher doses in the first place.
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It is unclear whether the FDA is going to take a closer look at JAK inhibitors as a class. After all, there have been many JAK class’ members that have not had similar adverse reactions. As more reviews provide new insights, the FDA could make additional recommendations moving forward based on these results.
Currently, the FDA is working with Pfizer to review the current safety information regarding tofacitinib they have. However, because not all drugs within the class have had issues, it is still too early to determine if all JAK inhibitors share the same safety concerns as Xeljanz.
Regardless, the adverse reactions of Xeljanz are serious and could be life-threatening if you are not careful. If you or someone you love suffered injuries while taking Xeljanz, do not wait. Our team of experienced attorneys possesses the skills and resources to thoroughly prepare your case to ensure you receive the compensation and justice you deserve. Contact Wormington & Bollinger to learn how we can help you.