The U.S. Food and Drug Administration (FDA), issued a Drug Safety Communication in September 2021. It gave a black box warning to the manufacturers of Rinvoq (upadacitinib). The communication asked the manufacturers, AbbVie Inc, to include the serious risks of blood clots, cancer, heart-related events, and death linked with their drug. It was issued after the results of the safety trials of another drug, Xeljanz/Xeljanz XR.
What is Rinvoq?
Rinvoq (Upadacitinib) is an oral medication used to treat adults with moderate to severe active rheumatoid arthritis (RA). It is generally given to patients who were given methotrexate and had an inadequate response or could not tolerate the drug. It belongs to a class of medications known as Janus kinase (JAK) inhibitors.
How does Rinvoq work?
Rinvoq has upadacitinib as the active ingredient and the following inactive ingredients- hypromellose, microcrystalline cellulose, tartaric acid, polyvinyl alcohol, mannitol, polyethylene glycol, magnesium stearate, ferrosoferric oxide, colloidal silicon dioxide, iron oxide red, titanium dioxide, and talc.
The drug works by decreasing cytokines, a protein that aids in controlling the immune system. During an infection, cytokines increase to fight it off. People who have rheumatoid arthritis (RA) make excess cytokines that cause pain and inflammation. Upadacitinib disrupts the Janus kinase (JAK) pathways from inside the cells to prevent the production of new cytokines.
In August 2019, the Food and Drug Administration (FDA) approved Rinvoq to treat moderate to severe active rheumatoid arthritis in adults who could not tolerate methotrexate or had an inadequate response to methotrexate treatment.
What is rheumatoid arthritis?
Rheumatoid arthritis (RA) is an inflammatory and autoimmune disease. It affects the joints in the knees, wrists, and hands. The lining of the joint gets inflamed and damages the joint tissue. This can cause chronic pain, lack of balance, and deformity.
RA has the following signs and symptoms:
- Pain and stiffness in multiple joints
- Swelling and tenderness in joints
- Weight loss
It can also damage tissues in the heart, lungs, and eyes. The treatment includes:
- Disease-modifying antirheumatic drugs (DMARDs) slow the spread of the disease and prevent deformity in the joints. This includes methotrexate.
- Anti-inflammatory drugs
- TNF inhibitor drugs
- JAK inhibitors
- Non-steroidal anti-inflammatory drugs
The recommended dose of Rinvoq is 15 mg once daily. It can be taken with or without food. It can be taken as monotherapy or combined with methotrexate or other non-biological DMARDs.
The tablets must not be swallowed whole or split, crushed or chewed. The use of Rinvoq is not recommended for patients with severe liver impairment or active serious infections. It should also not be given to patients whose absolute lymphocyte and neutrophil count and hemoglobin levels are below the prescribed limit.
Before administering Rinvoq, patients should be tested for tuberculosis (TB). For those with active TB or previously untreated latent TB, anti-TB therapy should be conducted first. It should also be carried out on patients with a negative result for latent TB but who are at risk for TB infection.
Side Effects of Rinvoq
Common side effects of Rinvoq include upper respiratory tract infections (common cold, sinus infections), cough, fever, and nausea. These are not exhaustive and do not include all the possible side effects.
Rinvoq also has some serious side effects. These include serious infections like:
- Oral/esophageal candidiasis
- Multidermatomal herpes zoster
- Cryptococcosis (Fungal infection of the lungs)
Other serious side effects of Rinvoq include:
- Deep vein thrombosis
- Pulmonary embolism
- Arterial thrombosis
- Cancers such as lymphoma and skin cancers
- Stomach or intestinal tears
- Change in lab tests
Upadacitinib and risk of blood clots
In the clinical trials for Upadacitinib, it was found that patients treated for inflammatory conditions with JAK inhibitors, including Rinvoq, were at an increased risk of developing pulmonary embolism (PE), arterial thrombosis, and deep vein thrombosis (DVT). Many of these incidents were serious, and some were fatal. Thus, it is advised to use Rinvoq very carefully in patients who have an increased risk of developing blood clots.
FDA Safety Communication
On February 4, 2021, the FDA issued a Drug Safety Communication after completion of the clinical trials of another drug Xeljanz/Xeljanz XR. The active ingredient in Xeljanz is tofacitinib. It also belongs to the class of JAK inhibitors. It is used to treat rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. The FDA warned that both Xeljanz and Xeljanz XR carried an increased risk of severe infections, heart problems, cancer, blood clots, and even death among patients.
Since Rinvoq (upadacitinib) belongs to the same JAK inhibitors drug class as Xeljanz/Xeljanz XR, the FDA issued a new Drug Safety Communication on September 1, 2021. It required the manufacturers to put an updated ‘Boxed Warning’ in the packaging of Rinvoq to include risks of heart-related events, blood clots, cancer, and death. Though Rinvoq has not undergone a similar safety trial as Xeljanz, they share the same action mechanism. Thus, the FDA considers that it may have the same risks as Xeljanz.
What is deep vein thrombosis (DVT)?
One of the serious side effects of Rinvoq is deep vein thrombosis (DVT). A form of venous thrombosis refers to a medical condition when a blood clot forms in a vein deep in the body. The clot partially or completely prevents blood from flowing through the vein. It usually happens in the lower legs or pelvis. A DVT can cause serious disability and even death.
The affected region of the body exhibits the following common symptoms of DVT:
- Tenderness, and
- Redness of the skin
- Veins near the skin of the affected area become larger than normal.
Pulmonary embolism (PE)
When a clot develops in a vein but stays there, it is referred to as a thrombus (for example, deep vein thrombosis). When the blood clot detaches from the vein and travels to another part of the body, it is called an embolus.
Clots in the lungs are called pulmonary embolism (PE). It refers to a blood clot that has traveled through the bloodstream and entered the vessels of the lung. It restricts the flow of blood to the lungs and depletes the oxygen in the lungs. This increases the pressure in the pulmonary arteries.
If treated properly, a pulmonary embolism can dissolve on its own and is not fatal. However, if left untreated, it can lead to complications and even death.
Common symptoms of pulmonary embolism include:
- Shortness of breath
- Coughing up blood
- Sharp chest pain, or pain in the shoulder, arm, neck, or jaw.
- Rapid heartbeat
- Excessive sweating
- Pale skin
- In some cases, passing out.
Arteries carry blood rich in oxygen from the heart to other parts of the body. When a blood clot blocks an artery, it is called arterial thrombosis. It may happen due to the hardening of the arteries, a condition known as arteriosclerosis. When calcium or fatty deposits thicken the artery walls, it leads to the deposition of plaque in these walls. This plaque can suddenly rupture and be followed by a blood clot. When arterial thrombosis occurs in coronary arteries that supply blood to the heart muscle, it can cause a heart attack. When it occurs in a blood vessel in the brain, it can cause a stroke.
Symptoms of arterial thrombosis depend on the location of the clot and vary from person to person. They include:
- Chest pain
- Swelling in the arm or leg
- Pain in one leg (usually in the inner thigh or calf)
- Numbness on one side of the body
- Sudden variation in mental state
Certain factors increase the risk of arterial thrombosis. These include diabetes, high cholesterol, high blood pressure, smoking, poor diet, lack of movement, lack of activity, obesity, family history of arterial thrombosis, and old age.
What is a Rinvoq lawsuit?
A Rinvoq lawsuit is a legal claim filed against drug manufacturer AbbVie Inc. The plaintiffs are people who consumed the drug as part of their treatment for rheumatoid arthritis and suffered an injury. The lawsuit offers them a chance to hold AbbVie liable and get compensation for their suffering.
Who can file a Rinvoq lawsuit?
People who took Rinvoq and were later diagnosed with pulmonary embolism, arterial thrombosis, blood clots, serious heart problems, or cancer can file Rinvoq lawsuit claims against AbbVie Inc. They should consult a law firm and ensure that they meet the criteria to become eligible plaintiffs. They will have to show the following:
- They were prescribed Rinvoq for their treatment.
- They took the prescribed dose, and
- They suffered side effects.
If you think you have a case, you can approach a law firm for a free case review. Our law firm offers a free consultation.
Grounds for filing a Rinvoq lawsuit
Rinvoq lawsuits are based on the grounds of defective design and failure to warn people of the health risks associated with the drug.
Product liability claims against pharmaceutical companies are filed based on defective manufacturing, dangerous side effects, and improper marketing of the drug. In case of defective manufacturing, the manufacturer is held liable for the drug that is improperly manufactured or somehow becomes tainted. This can be due to an error made at any point in the chain from the factory to the place where the patient gets the drug.
Improper marketing in the case of pharmaceuticals refers to inadequate warnings or instructions about the use of the drug. It includes the failure of the manufacturer to warn people about the dangerous side effects of the drug.
The plaintiff will have to prove that the manufacturer designed a defective drug and did not conduct adequate tests to test for its safety and efficacy. They will also have to show that the manufacturer failed to warn healthcare providers and the general public about the health risks associated with their drug and did not include adequate warnings in the labeling of the drug.
What can be claimed as compensation?
When demanding compensation, a law firm will examine the severity of the injury and the extent of suffering caused. The following can be claimed as compensation:
- Past and future medical expenses
- Lost wages
- Pain and suffering, including physical and mental, are caused by the injuries.
- Loss of earning capacity
- Other economic damages
If the case goes to trial, the jury may award punitive damages to punish the defendants for their conduct.
Will the lawsuit be a class action?
A class-action lawsuit is when several people who have suffered the same injury come together and file a lawsuit against the same defendant. For the Rinvoq lawsuit to be a class action, many people must suffer the same injury to qualify as a “class” and come together to file a case against the manufacturer.
Most product liability litigation is consolidated as multidistrict litigation (MDL). It differs from a class action as it has numerous cases that are consolidated into one litigation before a single court for pre-trial purposes. The plaintiffs retain their individual lawsuits. The judge selects a few cases to go forward to bellwether trials. These are sample jury trials that allow the parties to gauge how the judge and jury will perceive the case in an actual trial. They act as vital indicators in settlement negotiations between the plaintiffs and the defendant. If there is no settlement, the individual lawsuits return to the original district courts where they were first filed and then proceed to trial.
Statute of limitations
It is important to file a lawsuit within the prescribed time limit; else it will not be accepted. This limit is stated in the statute of limitations. It differs with each state. In some states, the statute begins to run from the day the injury occurs. In other states, it runs from the day the injured person discovers (or should have discovered) the injury. A law firm can help ascertain the exact time when the statute starts running and the deadline to file the lawsuit.
Do I have a Rinvoq Lawsuit?
If you or a loved one has been injured after taking Rinvoq, you should speak with the lawyers at Johnson // Becker.
We offer a Free Case Evaluation. Please contact us using the form below or by calling us at (800) 279-6386. We would be honored to speak with you and respond promptly to every inquiry we receive.