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If you have rheumatoid arthritis, you may have been prescribed a medication called Xeljanz or Xeljanz XR. This prescription medicine is becoming a leading choice for adults when methotrexate and other medications fail to make a difference in the symptoms. It may also be given in conjunction with other medications to help the patient respond better.
Secondary uses for Xeljanz include ulcerative colitis and to block specific enzymes that impact the immune system. There are risks associated with taking this medication, and a medical provider may want to perform a test to make sure there is no infection before starting a person on a dosage.
Some people may have been given this medication even though it shouldn’t have been prescribed to them. Because of resulting complications, they may be eligible for a Xeljanz lawsuit to receive compensation for their losses.
What is Rheumatoid Arthritis?
Rheumatoid arthritis or RA is a debilitating type of arthritis that causes inflammation in joints and may progress to the point of losing mobility. It especially affects the fingers, wrists, ankles and feet. Do a search online and you can easily see how this condition can severely impact a person’s life. Several drugs have been approved to treat RA, but they have varying degrees of success.
RA is known as an autoimmune disease, which is when your immune system starts to attack your own body. As it worsens, the condition goes beyond your joints to other body parts, including your eyes, heart, skin, blood vessels and lungs.
Options for treatment often include medications, such as anti-inflammatory painkillers and corticosteroids. The patient may use topical pain relievers and narcotic prescription medications for severe pain. Other drugs do their job of suppressing the attacks from the immune system. Methotrexate is one of the most popular choice of these disease-modifying antirheumatic drugs (DMARDs). Arava, Plaquenil and Azulfidine are other DMARDs. There is no cure for RA, but early treatment can slow the progress of the disease and even allow for remission.
What Does Xeljanz Do and What Are the Risks?
Xeljanz is the trade name for tofacitinib (the active ingredient in the drug), which was approved by the Food and Drug Administration (FDA) in 2012. It is a drug manufactured by Pfizer, which is based out of New York City. This medication is a Janus kinase inhibitor and it works by targeting a cellular process and often is successful where other treatment medications fail.
This medication is a common choice to reduce pain and inflammation in the joints caused by rheumatoid arthritis if taken correctly. Many patients have reported improvements with the medicine and an improved quality of life with decreasing pain in their body. However, the fact is that not everyone is a good candidate and there is concern about the safety of the drug. Arthritis patients should alert their doctor if they have experienced the following conditions:
- Chronic infection
- Cancer of any kind
- Problems with the stomach or intestines
- Liver disease – especially if it is Hepatitis B or C
- Kidney disease
If a person has traveled recently or is scheduled to receive vaccinations to travel overseas, they need to alert their doctor for use of this medication. If someone has spent time in certain areas of the country, including Ohio and any state in the Southwest, they may also be at a higher risk for complications because of possible exposure to a fungal infection.
Xeljanz can lower the blood cell count and weaken your immune system. Bloodwork is usually done more often, and other examinations may be necessary to ensure the medication doesn’t cause damage. Another concern is the increased risk for certain types of cancers, including lymphoma.
A person who takes this medication is at an increased risk for infections. Signs of an infection could include the following:
- Chills and/or sweating
- Muscle pain or tiredness
- Increased need to urinate or pain and burning during urination
- Stomach pain
- Weight loss
- Shortness of breath and coughing
- Pink or red mucus when coughing
It is recommended that the patient alert the doctor if they have a low red blood cell count, signs of hepatitis, shingles or indications of a tear or hole in the stomach. Any signs of tuberculosis should be reported as well.
Side effects associated with Xeljanz include shingles, skin rash, headaches, diarrhea, symptoms of a cold, increased blood pressure and blood tests that are abnormal.
Other drugs may interact with this medication, especially if you are on prescription medications for arthritis or ulcerative colitis, which this medicine is designed to treat. Drug interactions can be severe and cause other complications. All concerns and possible side effects need the attention of a medical professional. It is important to get them involved as early as possible to prevent further problems.
The Increased Risk of Death with Xeljanz
While the listed side effects and cautions are enough to make anyone understand the seriousness and dangers of this drug, other potential problems exist for which the public hasn’t been alerted. If the manufacturer fails to provide the required warning, they may be held liable.
The FDA approved the use of Xeljanz for moderate to severe rheumatoid arthritis at 5 mg two times per day. The 10 mg twice a day dosage was only for those diagnosed with ulcerative colitis. However, some patients have been prescribed the higher dose for RA, which may change how the body handles the drug.
The FDA clinical trial is going on through 2019 with a review of the impact of the two dosages, but there are indications that patients taking the 10 mg twice-daily have an increased risk of a pulmonary embolism, which is a blood clot in the lung, compared to those who are taking the lower dose. They are also at a higher risk for death. It’s important to note that the FDA approved the lower dosage for treating arthritis but not the higher dosage. The FDA also denied approval for using the medication to treat psoriatic arthritis.
Anyone who has taken this medication and has the following symptoms occur should seek medical help immediately:
- Sudden onset of shortness of breath
- Chest pain
- Difficulty breathing
- Extreme sweating
- Coughing up blood
- Skin that has a blue tint or is clammy
These symptoms could be indications of a serious and life-threatening condition.
The European version of the FDA, the European Medicines Agency, rejected this medication because they could not find a study that supported its benefits to counteract the dangerous risks.
Filing a Xeljanz Lawsuit
Because of the seriousness of the side effects from the higher dosage of Xeljanz, patients who have suffered a severe medical condition from taking this medication may be eligible for compensation. The cost of medical care is expensive, and some people have lost family members due to the side effects. There is even a Facebook group for people who believe they have reason to file a lawsuit for their situation. This is a developing issue with more claims likely to be made against the product by multiple plaintiffs in the next few years.
While there have been no recall events for this drug, it may be claimed that the medication is defective and poses a significant danger to the patients who take it.
It is possible to recover damages for the following:
- Past medical bills
- Future medical bills
- Past lost wages
- Lost wages in the future
- Emotional and mental distress
For the surviving family members of the patients who passed away from complications with the medication, they may be able to receive compensation for funeral expenses, wrongful death and the mental pain as well as lost financial support.
Filing a lawsuit against a major manufacturer like Pfizer, who makes tofacitinib, is quite complicated. There must be proof that the company knew of the dangers and failed to provide adequate warnings to patients. An experienced personal injury attorney with a background in this type of class action lawsuit can help you determine whether your situation qualifies for legal action with a free case evaluation and assist you in building a case.
If you have suffered from this medication or lost a family member or other loved one because of the side effects, you may be eligible to receive compensation with litigation. If the manufacturer is proven to have failed in providing a disclaimer for health risks linked to this medication, they may be held liable and you may receive remedies in a settlement. It is important that you seek legal help today for your situation and find an experienced attorney to represent you.