According to a recent FDA safety communication, Rheumatoid arthritis patients taking the 10 mg twice-daily dose of Xeljanz or Xeljanz XR may be at an increased risk for blood clots in the lungs (pulmonary embolism) and death.
The FDA issued this warning following the release of data from a clinical study of the drug showing an increased risk. The FDA warns patients to be aware of this risk and to watch for signs of pulmonary embolism (PE), which may include:
- shortness of breath,
- difficulty breathing,
- chest pain,
- coughing up blood,
- excessive sweating, and
- clammy or bluish-colored skin.
Chaffin Luhana is investigating cases in which patients took Xeljanz and then suffered serious injuries and/or death because of its dangerous side effects.
Xeljanz Found to Increase Risk of Blood Clots and Death
On February 25, 2019, the FDA released a safety communication notifying the public of an increased risk of blood clots in the lungs and death in RA patients taking the 10 mg twice-daily dose of Xeljanz or Xeljanz XR. At the time of this writing, the FDA had not approved the 10 mg twice-daily dose for RA—only for ulcerative colitis.
The FDA based this action on the results of the ongoing clinical trial they required Pfizer to conduct when they originally approved the drug in 2012.
Pfizer studied patients with RA to evaluate the risk of heart-related events, cancer, and infections with two doses of the medication (10 mg twice daily and 5 mg twice daily) in combination with methotrexate. They then compared the results to patients treated with another RA treatment drug. The patients had to be at least 50 years old with at least one cardiovascular risk factor, like high blood pressure.
Though the trial is not yet complete, the most recent analysis of the data showed an increased occurrence of blood clots in the lungs and death in patients treated with 10 mg twice daily compared to patients treated with 5 mg twice daily, or with the alternative medication.
Because of these results, the FDA advised patients to talk to their doctors about their dosages and to watch for signs of pulmonary embolism (PE). They also encouraged healthcare professionals to follow the prescribing information for the specific condition they are treating and to monitor patients for signs of blood clots and pulmonary embolism.
Europe Delays Approving Xeljanz Based on Uncertain Safety Profile
Back in 2013, the European Medicines Agency (EMA), which operates similarly to the FDA, initially declined to approve Xeljanz because they didn’t believe that the medication’s benefits outweighed its risks. The Committee for Medicinal Products for Human Use (CHMP) recommended against approving it, after determining that the drug did not demonstrate a favorable risk-benefit profile.
The committee acknowledged that the drug improved signs and symptoms of RA and improved physical function, but they do not believe it did enough to reduce disease activity and structural damage to the joints. They also questioned the drug’s potential side effects like infections and malignancies reported in Xeljanz clinical trials.
In March 2017, the European Commission reversed its stance and approved the medication for adult patients with moderate-to-severe RA. The approval was for the 5 mg twice-daily dose in combination with methotrexate for those patients who didn’t respond well to other RA drugs. They based this action on a review of a phase-three trial and real-world data.
At the time of this writing, the EMA was analyzing Pfizer’s clinical trial showing the risk of pulmonary embolism. They are expected to take similar action in warning patients and healthcare providers of the risk.
Types of Injuries Associated with Xeljanz
Patients who take Xeljanz may be at increased risk for:
- Blood clots
- Deep vein thrombosis (DVT)
- Pulmonary embolism (PE)
The Xeljanz label also warns of other serious side effects:
- Serious infections
- Perforations of the stomach or intestines
- Lymphoma and other cancers
- Liver problems
- Non-melanoma skin cancers
- Hypersensitivity reactions
What is Rheumatoid Arthritis?
Rheumatoid arthritis (RA) is an autoimmune disease, meaning it’s caused by a malfunctioning immune system. Whereas immune cells typically attack invaders like bacteria and viruses, in patients with RA, immune cells mistakenly attack healthy cells in the joints.
As the immune system tries to eradicate these healthy cells, it causes inflammation in the tissue lining the inside of the joint (the synovium). The tissues swell and thicken, causing pain and difficulty moving. Without treatment, the inflammation damages the cartilage that cushions the joint, as well as the bones themselves.
Eventually, RA may cause permanent cartilage damage. When the space between the bones in the joints is reduced, the joint won’t move as easily as it once did, and may become loose, unstable, and deformed. This damage, once it occurs, is irreversible, which is why patients are best served by early and aggressive treatment.
RA typically affects joints in the hands and feet, but it can also affect the wrists, knees, elbows, and ankles. The disease can progress to other bodily systems, including the skin, eyes, lungs, heart, and blood vessels, with the immune system mistakenly attacking cells and tissues in these areas as well.
RA increases the risk of many other problems, including osteoporosis, dry eyes and mouth, infections, carpal tunnel syndrome, heart problems, and lung disease.
What is Xeljanz?
Xeljanz (tofacitinib) and Xeljanz XR (extended release) are prescription medications used to treat adults with moderately to severely active RA in whom methotrexate (another RA medication) did not work well. They can be taken alone or with other medications like methotrexate.
Unlike other RA treatments, Xeljanz is not an injection, but a pill. Xeljanz is the 5 mg immediate-release option typically taken twice a day, and Xeljanz XR is the 11 mg extended-release once-daily pill option. In addition to RA, the medications are also used to treat adults with active psoriatic arthritis in which methotrexate or other similar medications did not work well, and in adults with moderately to severely active ulcerative colitis.
Xeljanz was proven in clinical trials to help reduce RA joint pain, swelling, and joint damage in adults with moderate to severe RA, and to help reduce further joint damage. The first in a new class of treatments for moderate to severe RA called Janus kinase (JAK) inhibitors, the drug inhibits the activity of one or more of the Janus kinase family of enzymes. As it does so, it interferes with the inflammatory process inside the cell, reducing inflammation and easing pain and swelling.
The FDA first approved Xeljanz on November 6, 2012, for the treatment of moderately to severely active RA. They noted that the drug provided a new treatment option for adults suffering from RA who had experienced a poor response to methotrexate.
Before granting approval, the FDA reviewed seven clinical trials in adults with moderately to severely active RA, noting that in all the trials, patients treated with the drug experienced improvement in clinical response and physical functioning compared to patients treated with a placebo.
According to the studies, however, Xeljanz use was associated with an increased risk of some potential side effects, including serious infections, tuberculosis, cancer, and lymphoma. Because of these risks, the FDA required the manufacturer to include a boxed warning on the label alerting healthcare professionals and patients to the potential side effects. They also required Pfizer to conduct a postmarketing study to evaluate two different doses of Xeljanz.
The FDA later provided the following additional approvals:
- February 2016: Xeljanz XR for the treatment of RA
- December 2017: both medications for the treatment of active psoriatic arthritis
- May 2018: Xeljanz for the treatment of moderately to severely active ulcerative colitis
What is Pulmonary Embolism?
A pulmonary embolism (PE) is a blood-clot induced blockage in one of the arteries leading from the heart to the lungs. The word “embolism” means “stopper” or “plug.”
The type of blood clots that cause PE typically come from another part of the body—most commonly from the deep veins in the legs. The blood clot forms in the vein, then breaks loose and travels through the bloodstream to the lungs. If it reaches the lungs, it can create a life-threatening situation.
Symptoms of PE include shortness of breath, chest pain that often gets worse when breathing deeply, cough, clammy skin, excessive sweating, fever, rapid or irregular heartbeat, lightheadedness, and leg pain or swelling, usually in the calf. Patients experiencing these symptoms should seek immediate medical attention.
PE can lead to other complications, including pulmonary hypertension or high blood pressure in the lungs. With the blood clot blocking blood flow, the heart has to work harder to try to push the blood through the arteries. This increases blood pressure, which can weaken or damage the heart. PE can also permanently damage the lungs.
Swift treatment can prevent these complications, and often involves medications that help dissolve the clot(s).
If you or a loved one took Xeljanz and suffered serious injuries and/or death, you may be eligible to file a Xeljanz lawsuit to recover damages. Chaffin Luhana is now investigating these cases, and invites you to call today at 888-480-1123.