Whenever scientists and healthcare experts design a new prescription drug, they do so with the intent to help those suffering from an illness or another debilitating condition. More often than not, they do just that. While all prescription drugs come with inherent risks, for the U.S. Food and Drug Administration (FDA) to approve them, they must determine that their health benefits outweigh their risk.
Unfortunately, there are instances when unforeseen side effects occur that lead to serious injury or even death. Such is the case with Xeljanz.
The FDA first approved Xeljanz as a treatment for rheumatoid arthritis in moderate to severe cases in 2012. They eventually approved its use for psoriatic arthritis in 2017 and ulcerative colitis in 2018. However, in the time since its approval, more and more cases of this drug causing adverse side effects in patients have come to light, leading many to file dangerous drug cases against the drug manufacturer, Pfizer.
For those who have suffered injuries after taking Xeljanz, filing a dangerous drug claim with the help of a trusted personal injury attorney may be their only shot of receiving compensation. While we now know the potential dangers this drug presents, what is Xeljanz’s effect on your body?
If you or a loved one suffered adverse reactions due to taking Xeljanz, contact the dangerous drug attorneys at Wormington & Bollinger and let us fight for you.
Adverse Reactions of Xeljanz
According to the Xeljanz website, doctors have prescribed 196,130 patients this drug. For many, it has done what experts intended it to do. For others, however, it has led to a host of side effects, with many being potentially life-threatening.
In 2019, the FDA released a safety announcement warning of taking a 10mg daily dose of tofacitinib (the active ingredient of Xeljanz). This warning states that those taking the drug are at an increased risk of blood clots and death. They even approved their most prominent Black Box Warning.
The drug causes two kinds of blood clots: pulmonary embolism (PE) and deep vein thrombosis (DVT). PE refers to blood clots in the lungs, while DVT refers to blood clots more commonly found in the thighs and lower legs. Each has a high-risk factor.
Some side effects those with PE may experience include:
- Shortness of breath
- Chest pain
- Irregular heartbeat
- Coughing
- Lightheadedness, fainting
- Back pain
- Unusual perspiration
- Coughing up blood in extreme cases
Those with DVT may experience:
- Swelling in the foot, ankle, or leg, typically on one side
- Cramping
- Severe pain in your foot or ankle
- An area of skin that feels warmer than the rest
- Tenderness
If you experience any of these symptoms or reactions, seek medical attention immediately. These conditions can be fatal if you don’t receive the appropriate medical treatment. If you suffered an injury due to Xeljanz’s effect, contact Wormington & Bollinger. We will help you receive compensation for your injuries.
Xeljanz’s Effect on Your Body
Xeljanz has been approved to treat rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. What connects each condition is the fact that each has an overactive immune system. This overactive immune system starts attacking healthy cells and tissue. Unfortunately, this response leads to inflammation in the joints, which causes pain and reduces function.
Tofacitinib is the active ingredient in Xeljanz, which belongs to a class of drugs known as Janus kinase inhibitors (JAK inhibitors). Those with rheumatoid arthritis produce too many proteins called cytokines. These cytokines help manage your immune system. When you have an infection, your body creates more of them.
However, when there is an excess, it leads to inflammation. These proteins attach to receptors on immune cells, sending a message to produce more cytokines.
JAK inhibitors disrupt this process by blocking the message pathways. When these inhibitors do this, they calm the immune system down, easing the inflammation and your symptoms. For those with psoriatic arthritis and ulcerative colitis, the drug works the same way.
However, this suppression of the immune system leaves you more susceptible to infection. It decreases your body’s ability to fight back against bacterial, mycobacterial, fungal, and viral infections.
Xeljanx Leads to Blood Clots
Back in 2012, when the FDA first approve Xeljanz, they required another study to evaluate patients’ risk of heart-related events, cancer, and infections. An interim analysis discovered that patients who took tofacitinib 10mg twice a day had an increased occurrence of blood clots and death than patients who took 5mg twice a day or a tumor necrosis factor (TNF) blockers.
Following this discovery, the FDA stopped all prescriptions of 10mg twice a day, allowing patients to continue treatment on 5mg twice a day. This trial is still ongoing.
As of January 2019, the interim results found:
- 19 cases of blood clots in the lung of those taking tofacitinib 10mg twice daily
- 45 cases of death of those taking tofacitinib 10mg twice daily
Pfizer released a statement themselves discussing the change of doses after the FDA found these results.
The FDA has not approved the dosage of 10mg for rheumatoid arthritis and psoriatic arthritis. However, they still approve of its use for ulcerative colitis, but they believe those with ulcerative colitis may still be at risk.
We know that Xeljanz can increase your cholesterol levels. High cholesterol can develop fatty deposits in your blood vessels that can build up over time, which disrupts blood flow and can break off and cause blood clots.
Contact Wormington & Bollinger
You expect prescription medications to help treat diseases and conditions that plague your everyday life. While these drugs cannot hit the market with FDA approval, they all carry inherent risks. Fortunately, their health benefits outweigh these risks.
However, unforeseen circumstances can arise that put your life in danger, such as with patients who take Xeljanz. This drug has proven an effective treatment for rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis, but some adverse side effects popped up over the years. It has led to cases of blood clots in patients, putting their lives at risk. Xeljanz’s effect on your body can prove to be dangerous if you are not careful.
If you or a loved one suffered injuries after taking Xeljanz, contact the dangerous drug attorneys at Wormington & Bollinger and let us fight for the justice and compensation you deserve.