In September 2021, the Food and Drug Administration (FDA) issued a Drug Safety Communication and a black box warning to the manufacturers of Olumiant (baricitinib).
The communication asked the manufacturers to include the warning of serious risks of blood clots, cancer, heart-related events, and death linked with their drug, on the packaging of the product.
It was issued after the results of the clinical trial of another drug, Xeljanz/Xeljanz XR.
What is Olumiant?
Olumiant (baricitinib) is an oral medication used to treat adults with moderate to severe active rheumatoid arthritis (RA). It is generally given to patients who have been given at least one other Tumor Necrosis Factor (TNF) antagonist medicine but did not get an adequate response.
Olumiant belongs to a class of drugs known as Janus kinase (JAK) inhibitors. These are intracellular enzymes. They interfere with the production of cytokine, a protein that aids in controlling the immune system.
How does Olumiant work?
Olumiant has baricitinib as the active ingredient. The inactive ingredients are magnesium stearate, croscarmellose sodium, microcrystalline cellulose, mannitol, polyethylene glycol, ferric oxide titanium dioxide, polyvinyl alcohol, lecithin (soya), and talc.
They work 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. Olumiant disrupts the Janus kinase (JAK) pathways from inside the cells to prevent the production of new cytokines.
In 2018, the Food and Drug Administration (FDA) approved Olumiant to treat moderate to severe rheumatoid arthritis in adults who have had an inadequate response to one or more Tumor Necrosis Factor (TBF) antagonist therapies.
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.
- Anti-inflammatory drugs
- TNF inhibitor drugs
- JAK inhibitors
- Non-steroidal anti-inflammatory drugs
The recommended dosage for Olumiant is 2mg once daily. It is given with or without food. It can be used as monotherapy or be combined with other drugs such as methotrexate or other DMARDs. It is pertinent to note that Olumiant should be taken exactly as prescribed.
The use of Olumiant is not recommended for patients with severe liver impairment or those taking strong Organic Anion Transporter 3 (OAT 3) inhibitors. It is also recommended to avoid using Olumiant in patients who have active, serious infections, including localized infections.
Before administering Olumiant to patients, it is advised to check them for latent tuberculosis (TB). If found positive, TB should be treated first before administering Olumiant.
Side Effects of Olumiant
Since Olumiant works by suppressing the immune system, it has some associated side effects. In the clinical trials, patients with active rheumatoid arthritis were administered 2 mg and 4 mg of baricitinib daily. The most common side effects were cold sores, upper respiratory tract infection, herpes simplex, and nausea.
Rheumatoid arthritis patients receiving Olumiant have been found to be susceptible to serious infections due to bacterial, viral, invasive fungal, or mycobacterial pathogens.
The serious side effects of the drug include:
- Herpes zoster
- Urinary tract infection
- Risk of cancer including lymphoma and skin cancers
- Blood clots in lungs (pulmonary embolism) or veins in the legs (deep vein thrombosis)
- Stomach or intestinal tears
- Allergic reactions
- Change in lab tests: The use of Olumiant is not recommended for patients whose blood counts are too low or liver tests too high. If the results change, the treatment may be paused.
Olumiant and risk of blood clots
In the clinical trials for Olumiant (baricitinib), it was found that patients given the drug posed a higher risk of developing deep vein thrombosis (DVT) and pulmonary embolism (PE).
Additionally, incidents of arterial thrombosis (clots in the arteries) were also reported. Many of these incidents were serious, and some were fatal. Thus, it was advised to use Olumiant very carefully in patients who had 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 Olumiant (baricitinib) 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 Olumiant to include risks of heart-related events, blood clots, cancer, and death. Though Olumiant 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 Olumiant 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 wholly or partially 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.
Pulmonary embolism (PE) develops when there are clots in the lungs. It refers to a blood clot that has traveled through the bloodstream and entered the lung vessels. 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 appropriately treated, a pulmonary embolism can dissolve on its own and is not fatal. However, if left untreated, it can lead to complications and even death.
Symptoms of PE
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.
What is an Olumiant lawsuit?
An Olumiant lawsuit is a legal claim filed against drug manufacturer Eli Lilly and Company. 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 the manufacturer liable and get compensation for their suffering.
Who can file an Olumiant lawsuit?
People who took Olumiant and were later diagnosed with pulmonary embolism, blood clots, severe heart problems, or cancer can file Olumiant lawsuit claims against Eli Lilly and Company.
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 Olumiant 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 an Olumiant lawsuit
Olumiant 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 manufacturers 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 manufacturers 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 Olumiant lawsuit to be a class action, many people must suffer the same injury to qualify as a “class” and come together to file a lawsuit 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 starts from the day the injury occurs. Whereas, in other states, it starts 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.
If you or a family member suffered from taking Olumiant, you might be eligible to file a lawsuit against Eli Lilly and Company.
Do I have a Olumiant Lawsuit?
If you or a loved one has been injured after taking Olumiant, 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.