Taking Xeljanz and alcohol can cause severe medical problems, especially if you are also taking methotrexate to treat rheumatoid arthritis. However, the manufacturer of Xeljanz, Pfizer, never mentions alcohol in the warning label for the drug.
The Shouse Law Office is helping people file Xeljanz lawsuits against Pfizer to recover the compensation they need and deserve. Reach out to them soon before the statute of limitations expires and keeps you from invoking your rights if you have taken Xeljanz and gotten hurt when it reacted to alcohol. In this article, we discuss:
- 1. Xeljanz and rheumatoid arthritis
- 2. Xeljanz and methotrexate
- 3. Alcohol can cause problems if taken with Xeljanz and methotrexate
- 4. Other side effects of Xeljanz
- 5. Xeljanz lawsuits over injuries caused by alcohol
1. Xeljanz and rheumatoid arthritis
Xeljanz is the brand name for the drug tofacitinib. It was designed by Pfizer, who still manufactures the drug and sells it.
Originally approved by the U.S. Food and Drug Administration (FDA) to treat rheumatoid arthritis in November, 2012,1 Xeljanz has since been approved to treat psoriatic arthritis in December, 2017,2 and to treat ulcerative colitis in May, 2018.3
Xeljanz works by reducing the efficacy of JAK, or Janus kinase enzymes. JAK enzymes play a crucial role in how cells interact with their surroundings, including when they replicate and grow. When JAK enzymes push cells to replicate too much, it can lead to a buildup of tissues in the body. When that tissue buildup happens in joints, it can damage the bone and cartilage that is already there, drastically reducing the mobility of the joint. It can also cause the immune system to attack the new tissue, exacerbating the inflammation and pain in the joint.
When this happens, it is rheumatoid arthritis.
By inhibiting JAK enzymes, Xeljanz treats rheumatoid arthritis by fighting against this process. It is an especially popular treatment because earlier drugs for rheumatoid arthritis had to be injected into the joint to work.
2. Xeljanz and methotrexate
Xeljanz is not approved for everyone to treat their rheumatoid arthritis. Instead, the FDA limited the approved use of Xeljanz to those who had already tried another drug, methotrexate, but either did not experience good results or were intolerant to it.4 Xeljanz can also be taken alongside methotrexate, which can go by its brand names Trexall or Rheumatrex, or other nonbiologic disease-modifying antirheumatic drugs (DMARDs).
As a result, a lot of people who take Xeljanz to treat their rheumatoid arthritis also take methotrexate as a supplement.
3. Alcohol can cause problems if taken with Xeljanz and methotrexate
Drinking too much alcohol while treating rheumatoid arthritis is known to cause serious liver problems.
Alcohol stresses the liver by forcing it to process and filter the vast majority of the alcohol that gets imbibed. When taken during rheumatoid arthritis treatment involving Xeljanz and methotrexate, that strain can get exacerbated.
Both Xeljanz and methotrexate also strain the liver, as the organ is responsible for processing most of the drugs. One post hoc analysis looked at 25 different studies to find that the levels of bilirubin and two important liver enzymes – ALT and AST – were more likely to be elevated above the upper limits of normal (ULN) for people taking Xeljanz than those in the placebo control groups5:
|Group Taking Xeljanz (8,115)||Group Taking Placebo Pills (1,841)|
|ALT Above the ULN||20.9%||15.7%|
|ALT Three Times Above the ULN||1.2%||0.8%|
|AST Above the ULN||15.0%||9.6%|
|AST Three Times Above the ULN||0.6%||0.5%|
|Total Bilirubin Above the ULN||3.3%||2.3%|
This data is important, because doctors consider AST (aspartate transaminase) and ALT (alanine transaminase) levels to be important benchmarks in liver damage.
The figures in the study were backed up by one of Pfizer’s own clinical trials for Xeljanz. In this clinical trial, 19% of people taking Xeljanz to treat their rheumatoid arthritis had ALT levels above the upper limits of normal. 3% of them had readings more than three times the upper limits of normal. Meanwhile, only 4% of the placebo group had elevated ALT numbers.6
Together alcohol, the strain that gets put on the liver by Xeljanz can lead to liver damage, liver failure, and all of its attendant consequences.
People taking both Xeljanz and methotrexate are even more at risk if they drink alcohol. One study found that moderate to heavy drinkers faced an increased risk of liver damage and liver disease if they were taking methotrexate at the time.7
4. Other side effects of Xeljanz
The severe complications that can happen when Xeljanz is taken with alcohol are not the only side effects that Xeljanz can cause. Some of the most severe side effects related to Xeljanz include:
- Liver damage,
- Blood clots in the lungs, which can lead to a pulmonary embolism, and
- Malignancies and cancer.
5. Xeljanz lawsuits over injuries caused by alcohol
Hundreds of lawsuits have been filed against Pfizer over injuries caused by Xeljanz and the complications it creates when taken with alcohol. These lawsuits all claim that Pfizer failed to warn victims of the potential for harm, and point to the fact that Xeljanz’s warning label never mentions alcohol.
Drug companies like Pfizer have a legal duty to disclose the risks associated with their drugs. Both doctors and patients rely on these disclosures to make informed and crucially important decisions about their health. However, revealing all of the dangers associated with a drug can cut into the profits it makes, so many drug companies err on the side of nondisclosure to protect their bottom line.
Xeljanz lawsuits claim that Pfizer’s lack of a warning about the effects of mixing Xeljanz with alcohol amounted to a failure of that legal duty to disclose the drug’s risks. The lawsuits seek compensation for:
- Medical expenses,
- Pain and suffering,
- Professional ramifications of a long and difficult recovery, and
- Loss of consortium and companionship felt by the victim’s family.
They also seek punitive damages against Pfizer for its poor conduct.
These lawsuits are likely to be consolidated into a multidistrict litigation, or MDL, in the near future. Claims like these that involve hundreds or potentially even thousands of victims who have all been hurt by one course of conduct are often consolidated into an MDL to streamline the process.
- FDA Approval Letter for Xeljanz (November 6, 2012).
- Press Release, “Pfizer Announces FDA Approval of Xeljanz® (tofacitinib) and Xeljanz® XR for the Treatment of Active Psoriatic Arthritis,” Pfizer, (December 14, 2017).
- FDA Approval Letter for Xeljanz to Treat Ulcerative Colitis (May 30, 2018).
- Xeljanz Warning Label (May 2018).
- Soriano ER, Madariaga H, Castañeda O, Citera G, Schneeberger EE, Cardiel MH, Hendrikx T, Graham D, Shi H, Ponce de Leon D, “FRI0099 Liver enzyme abnormalities after tofacitinib treatment in patients with hepatic steatosis from the rheumatoid arthritis, psoriatic arthritis and psoriasis clinical programmes,” Annals of the Rheumatic Diseases 77(2):593-4 (June 15, 2018).
- ClinicalTrials.gov Identifier No. NCT00603512, “Comparison Of 4 CP-690,550 Doses Vs. Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis in Japan,” published at Tanaka Y, Suzuki M, Nakamura H, Toyoizumi S, Zwillich SH, “Phase II study of tofacitinib (CP-690,550) combined with methotrexate in patients with rheumatoid arthritis and an inadequate response to methotrexate,” Arthritis Care and Research 63(8):1150-8 (August 2011).
- Humphreys JH, Warner A, Costello R, Lunt M, Verstappen SM, Dixon WG, “Quantifying the hepatotoxic risk of alcohol consumption in patients with rheumatoid arthritis taking methotrexate,” Annals of the Rheumatic Diseases 76(9):1509-14 (March 23, 2017).