Long-Term Complications of Xeljanz
Xeljanz has been in the U.S. market for the better part of a decade. It first received FDA approval for rheumatoid arthritis (RA) in 2012. Since then, the FDA has approved Xeljanz for three other conditions: psoriatic arthritis (PA), ulcerative colitis (UC), and active polyarticular course juvenile idiopathic arthritis (pcJIA). Pfizer (Xeljanz’s manufacturer) is also seeking approval for a fifth condition, ankylosing spondylitis (AS). As is the case with all prescription drugs, Xeljanz does have side effects. While the majority of these side effects are minor, some of them can be life-threatening. From severe allergic reactions to increased risks of blood clots, there are plenty of adverse reactions that require immediate medical attention. However, while we know the side effects, what are the long-term complications of Xeljanz? Xeljanz has only been on the market for under ten years. Researchers and healthcare experts still have much… Read More
Exploring the European Medicines Agency’s Denial of Xeljanz
For a drug to enter the market, manufacturers must conduct extensive research and testing to ensure the medication does as they designed it to and is safe to use. Once completed, they must then submit their findings to the U.S. Food and Drug Administration for further testing to verify that the drug is safe and effective. If they confirm the results, they will approve the drug. Pfizer (Xeljanz’s manufacturer) had to go through this exact process. The FDA did initially approve Xeljanz for rheumatoid arthritis in 2012. They later approved Xeljanz for psoriatic arthritis and ulcerative colitis. Most recently, they approved it for polyarticular course juvenile idiopathic arthritis (pcJIA). However, Pfizer didn’t just stop with FDA approval. The drug manufacturer also tried to get Xeljanz approved for use in Europe. However, they did not meet the same results. The Committee for Medicinal Products for Human Use… Read More
Xeljanz and Liver Damage
Xeljanz has been on the market for nearly ten years. The U.S. Food and Drug Administration (FDA) first approved the drug for rheumatoid arthritis in 2012. Since that initial approval, the FDA approved Xeljanz for psoriatic arthritis (PA) and ulcerative colitis (UC) in 2017 and 2018, respectively. Most recently, the FDA approved Xeljanz for active polyarticular course juvenile idiopathic arthritis (pcJIA) in 2020. As is the case with all prescription drugs, Xeljanz is not free of side effects. When seeking approval, drug manufacturers must provide the FDA with the results of their own testing and clinical trials, which include side effects. Unlike the increased risk of blood clots (which was not discovered until after the FDA’s approval), liver damage was a known potential side effect of taking the drug. Your liver is one of the most vital organs in the body. When there are any… Read More
Examining the Conditions Xeljanz Treats
Every year, the U.S. Food and Drug Administration (FDA) approves countless new drugs to enter the market. These drugs have to go through an arduous development process that often takes years. Once the manufacturer has designed a medication, they must send it to the FDA for approval. It will then go through a thorough approval process to ensure the drug is safe and does what it was designed to do. They must also make sure the benefits outweigh the risks. The FDA first approved Xeljanz in 2012 as a treatment for rheumatoid arthritis. Since its initial approval, the FDA has added to the list of conditions Xeljanz treats. They approved the drug for psoriatic arthritis (PS) and ulcerative colitis (UC) in 2017 and 2018, respectively. Most recently, in September 2020, the organization approved Xeljanz for active polyarticular course juvenile idiopathic arthritis (pcJIA) in children and… Read More
Pfizer Seeking FDA Approval for Xeljanz in Ankylosing Spondylitis (AS)
The U.S. Food and Drug Administration (FDA) first approved Xeljanz for rheumatoid arthritis (RA) in 2012. Eventually, the FDA approved Xeljanz for other conditions, first for psoriatic arthritis (PA) in 2017 and then again for ulcerative colitis (UC) in 2018. In September 2020, Pfizer announced that the FDA had officially approved Xeljanz for active polyarticular course juvenile idiopathic arthritis (pcJIA) in children and adolescents two years old and younger. Even after the FDA released the results of its interim analysis on Xeljanz, revealing an increased risk of blood clots and death, Pfizer continues to push for the drug’s approval for other conditions. Recently, Pfizer announced the results of a Phase 3 study for Xeljanz in ankylosing spondylitis (AS). The FDA has not approved tofacitinib (the active ingredient in Xeljanz) for the treatment of AS in the U.S., but the positive results of this Phase 3… Read More
The History of JAK Inhibitors
In recent years, the drug Xeljanz and its manufacturer (Pfizer) have come under fire due to side effects that Pfizer had not disclosed to the FDA, doctors, patients, or pharmacies. While they claim they were unaware of these side effects, the risk they present is real, regardless of if Pfizer knew about them or not. The FDA has placed its most prominent black box warning, which warns about the increased risk of blood clots and death. With Xeljanz in hot water, other similar medications are also under scrutiny. The active ingredient in Xeljanz is tofacitinib. This ingredient falls under a class of drugs known as Janus kinase inhibitors (also referred to as JAK inhibitors). These inhibitors are disease-modifying antirheumatic drugs (DMARDs) and are often used to treat rheumatoid arthritis and other similar diseases. However, after the FDA's discovery, all JAK inhibitors are being carefully watched.… Read More
Xeljanz Approved for Juvenile Idiopathic Arthritis by FDA
In recent years, Pfizer has come under fire due to the adverse reactions of Xeljanz. In early 2019, the U.S. Food and Drug Administration (FDA) released the findings of its interim analysis, which uncovered an increased risk of blood clots and death. Pfizer did not tell the FDA about these reactions, claiming that they were unaware of them. However, after the FDA placed its black box warning on Xeljanz, it still approved it for use as a treatment for rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis in low doses. Even with the FDA’s recent discovery, Pfizer is still looking to get Xeljanz approved for other conditions. In September 2020, Pfizer announced that the FDA had approved Xeljanz as a treatment for active polyarticular course juvenile idiopathic arthritis (pcJIA) in children and adolescents two years old and younger. This approval makes tofacitinib the first (and only)… Read More
Do the Safety Concerns of Xeljanz Translate to Other JAK Inhibitors?
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… Read More
How Deadly are Xeljanz’s Adverse Reactions?
In 2012, the U.S. Food and Drug Administration (FDA) approved Xeljanz for use as a treatment for rheumatoid arthritis. The FDA eventually approved the drug for psoriatic arthritis in 2017 and ulcerative colitis in 2018. As is the case with all prescription medications, Xeljanz is no stranger to side effects. While many of these side effects are minor, some of Xeljanz’s adverse reactions are far more severe and potentially life-threatening. These minor side effects can range from headaches to flu or cold-like symptoms. Typically, these side effects do not last very long. However, Xeljanz has the potential to lead to more severe reactions. Some of Xeljanz’s adverse reactions can be far deadlier, leading to significant health complications. These reactions have even led the FDA to include several black box warnings for serious infections, an increased risk of death, and even cancer. Recently, the FDA also… Read More
Understanding the FDA’s Interim Analysis on Xeljanz
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… Read More