September 2021 Xelijanz Update
On September 1, 2021, the FDA announced that it was requiring Xeljanz to come with a new, beefed-up warning label which conspicuously warns that users may have an increased risk of potentially life-threatening conditions such as heart attack, cancer, blood clots, and stroke.
This new warning requirement from the FDA comes after the agency conducted its own review of recent Xeljanz clinical trials and related studies, which first determined that users of the drug had a higher rate of serious heart-related problems, cancer, pulmonary embolism, and fatalities.
In its safety communication announcing the new warning label requirements, the FDA also clarified the evidence linking Xeljanz and cancer. According to the FDA, Xeljanz users displayed significantly higher rates of lymphoma and lung cancer compared to a control group. Evidence linking Xeljanz to other types of cancer was less definitive.
Xelijanz Lawsuits Our Lawyers Are Reviewing
Our lawyers are currently accepting new cases from people who took Xeljanz and had any of the following health events:
- Pulmonary Embolism
- Deep Vein Thrombosis
- Other types of blood clot injury
Xeljanz (tofacitinib) was first approved and released in 2012 by pharmaceutical giant Pfizer. Xeljanz was a groundbreaking new type of drug called a JAK inhibitor which has a unique internal effect on certain types of cells.
Xeljanz is similar in many ways to a biologic. But this drug is a new subcategory of disease-modifying antirheumatic drugs (DMARD) called "JAK inhibitors." Xelijanz that block Janus kinase (JAK) pathways that are involved in our immune responses. These agents target specific steps in the process. So, in theory, these drugs don't wipe out the entire immune response as do some other RA treatments
The drug is primarily used for the treatment of very severe cases of rheumatoid arthritis. However, since about 2017 Xeljanz has also been used to treat ulcerative colitis and psoriatic arthritis. Pfizer aggressively marketed Xeljanz and quickly became one of the company's blockbuster drugs because it was working as intended if you set aside the risks.
Xeljanz is now one of the most heavily marketed and profitable drugs in history. Pfizer has reaped billions of dollars in sales from Xeljanz. In fact, Pfizer reported $2.4 billion in worldwide Xeljanz sales in 2020. This is big money, the kind of drug a pharmaceutical company desperately wants to keep in the market.
Normal approved dose levels for Xeljanz are 5 mg and 10 mg twice a day. To prevent arthritis inflammation, Xeljanz has to essentially block or suppress a user's natural immune system responses. As a result, the drug always had a long list of potentially serious side-effects. However, blood clots were never originally listed as a potential side effect of the drug.Xeljanz and Blood Clots
As part of the initial FDA approval for Xeljanz back in 2012, Pfizer was required to conduct a long-term post-market research study. The aim of this post-approval study was to evaluate the potential risks of cardiovascular problems resulting from the drug.
The initial results of this long-term study were provided to the FDA at the beginning of 2019 and they caused major concerns. Specifically, the study found that the higher Xeljanz dose (10 mg twice daily) appeared to cause life-threatening blood clots in some patients.
In response to these study results, the FDA issued a safety announcement and Pfizer was required to add a "black box warning" (the most serious type of drug label warning) about the risk of blood clot deaths at higher doses. The higher, 10 mg dose of Xeljanz is no longer approved for the treatment of arthritis because the risk of blood clots is considered too high.
This whole class of drugs is giving cause for concern. In June 2021, the FDA decided to further extend the review period for Jakafi, a bone marrow disease drug by Incyte that is looking to get approved for steroid-refractory chronic graft-versus-host disease. What is the concern? The concern is that it might cause cardiac complications and/or cancer. Similarly, expanded approval Abbie's Rinvoq is being held up as abrocitinib.Xeljanz Lawsuits
Pfizer is now facing a rapidly growing number of lawsuits by users of Xeljanz who suffered blood clots or similar injuries. All pharmaceutical companies have a duty to fully research the safety of their drugs before they are approved and released. This is particularly true with completely new types of drugs such as Xeljanz.
Drug companies also have a legal duty to warn about any potential risks, side effects, or health concerns associated with their drug. This is information is often critical because it enables doctors to make informed decisions about drug safety for individual patients.
Xeljanz blood clot lawsuits against Pfizer are alleging that the company breached its duties to the public in several ways:
- Pfizer negligently failed to conduct adequate safety research and testing before getting approval for Xeljanz.
- Pfizer new that the higher dose of Xeljanz caused blood clots and other problems, but failed to disclose this information.
- Pfizer failed to warn that higher doses of Xeljanz may cause blood clots and cardiovascular problems.
Most of these allegations appear to be fairly valid and Pfizier will likely be facing serious liability in these cases. The warnings about Xeljanz and blood clots are fairly recent, so not many blood clot lawsuits have been filed against Pfizer at this point.
Pfizer will likely be named in hundreds of Xeljanz lawsuits across the country. As of September 2021, there is still no MDL class action but that could change.Can You File a Xeljanz Lawsuit?
To qualify as a potential Xeljanz plaintiff with our law firm, you will need to satisfy at least the following three requirements:
- You were taking Xeljanz or Xeljanz XR for treatment of arthritis for a minimum of 6 months.
- You were taking the higher Xeljanz dose - 10 mg twice a day.
- You suffered a pulmonary embolism, deep vein thrombosis, stroke or other blood clot related injury while taking Xeljanz.
If you (or a deceased family member) satisfies all three of these conditions, our law firm wants to talk to you.Settlement Compensation Payouts for Xeljanz Lawsuits
If you have a potential Xeljanz lawsuit, it is only natural to wonder how much money your case might potentially be worth. The potential settlement amount of individual Xeljanz cases will vary based on a number of factors.
The most significant factor in determining the settlement amount (or trial value) of an individual Xeljanz blood clot lawsuit will be the extent of the victim's injuries. Some people who suffer blood clots from Xeljanz may only end up with a stay in the hospital and few days of stress and discomfort.
Others may be left permanently paralyzed, partially disabled, unable to talk, or dead. Plaintiffs with more serious permanent injuries from Xeljanz will have higher settlement amounts.
In the context of medical malpractice cases, however, the settlement value for pulmonary embolisms and similar blood clot injuries tends to be fairly high. This is because pulmonary embolisms often have catastrophic consequences such as death or limb amputation.
Can our lawyers guess the average settlement amount for a Xeljanz blood clot lawsuit? Our guess, and it is just speculation, is that average compensation will be between $100,000 and $200,000 and the cases that go to trial will average in the millions. This has long been our lawyers' opinion and the FDA announcement in September 2021, only strengthens that opinion.Miller & Zois is Accepting New Xeljanz Cases
If you suffered a blood clot, stroke, or similar type of event while taking Xeljanz contact the dangerous drug lawyers at Miller & Zois at 800-553-8082 on contact us online.