FDA Warning: Xeljanz Patients at Risk of Pulmonary Embolism (Blood Clots in Lungs)
Patients taking Xeljanz and Xeljanz XR for rheumatoid arthritis or other conditions may have an increased risk of blood clots in the lungs. These clots could be fatal.
A pulmonary embolism is a blockage that occurs in one of the arteries in your lungs. Often these clots start in the legs and travel to the lungs. Because the clot blocks blood flow to the lungs, these embolisms can be fatal.
Warning Signs of Pulmonary Embolism:
- Chest pain. Often confused with a heart attack, the pain is usually worse when you try to breathe deeply (pleurisy) or cough.
- Shortness of breath.
- Difficulty breathing.
- Sometimes accompanied by bloody phlegm or mucus.
- Cyanosis (bluish colored skin and clamminess).
- Heavy sweating.
Secondary symptoms often include:
- Leg pain (often concentrated in the calf).
- Irregular heartbeat
History of FDA Involvement with Xeljanz
Xeljanz is manufactured by Pfizer, Inc, one of the largest pharmaceutical companies in the world. [The formal name of the drug is tofacitinib.] The FDA originally approved the drug in 2012 for use with patients suffering from moderate to severe rheumatoid arthritis. Later it was also approved for psoriatic arthritis and ulcerative colitis.
Between January 2013 and July 2018, approximately 132,000 patients in the United States took Xeljanz for rheumatoid arthritis. Pfizer reportedly earned $1.7 billion on its sales last year.
In February 2019, the FDA issued a safety alert about the risks of blood clots and death associated with Xeljanz. According to the report, between 2013 and 2018, the agency received 52 reports of deep vein thrombosis and 79 reports of pulmonary embolism. Of those patients reports, 15 were fatal.
Because they incidents are self-reported, there is no way of accurately estimating how many others have suffered from similar injuries or may have died. In our experience, many drug reactions are never reported to the FDA, either because the patient doesn’t know to report to his or her doctor or the connection between the symptom and drug is never made.
According to the FDA‘s February 2019 warning,
“The U.S. Food and Drug Administration (FDA) is alerting the public that a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR) was used in patients with rheumatoid arthritis (RA). FDA has not approved this 10 mg twice daily dose for RA; this dose is only approved in the dosing regimen for patients with ulcerative colitis.
“In this ongoing safety trial required by FDA when it approved tofacitinib for RA, the drug manufacturer, Pfizer, is transitioning patients who were on the high 10 mg twice daily dose to the lower, currently approved dose of 5 mg twice daily. This trial will continue and is expected to be completed by the end of 2019. We are working with the manufacturer to evaluate other currently available safety information for tofacitinib and will update the public with any new information based on our ongoing review.”
Pfizer claims it didn’t find the same risks as the FDA. A company press release said, “Similar results to study A3921133 have not been identified in Pfizer analyses of other tofacitinib RA clinical trials or routine monitoring of post-marketing safety data, including our statistical analyses of the FDA Adverse Event Reporting System database.”
We don’t know if the FDAstudy is complete but last week the FDA issued a “black box warning” for Xeljanz and Xeljanz XR. A black box warning is the strictest labeling requirement from the FDA. It is designed to warn patients and doctors of life threatening or serious health risks.
The new FDA black box warning says in part:
“For the treatment of UC [ulcerative colitis], use XELJANZ at the lowest effective dose and for the shortest duration needed to achieve/maintain therapeutic response.
“For patients with ulcerative colitis, use XELJANZ at the lowest effective dose and for the shortest duration needed to achieve/maintain therapeutic response.
“Avoid XELJANZ/XELJANZ XR in patients that may be at increased risk of thrombosis. For the treatment of UC, use XELJANZ at the lowest effective dose and for the shortest duration needed to achieve/maintain therapeutic response.
“The recommended dose for XELJANZ XR is 11 mg once daily. A dosage of XELJANZ 10 mg twice daily or XELJANZ XR 22 mg once daily is not a recommended regimen for the treatment of rheumatoid arthritis.
In effect, the FDA is not only warning about the risks of death, deep vein thrombosis and pulmonary embolism, it is also suggesting that doctors cut back on dosages of the drug.
Certainly, patients taking the drug at twice daily 10mg version of the product have an exponentially higher risk of suffering death and thrombolytic events but that doesn’t mean patients on lower dosages are out of the woods.
The FDA’s black box warning and February 2019 safety alert were mostly concerned with pulmonary issues such as embolisms and deep vein thrombosis. Pfizer had many other warnings, however, including these:
“Patients treated with XELJANZ / XELJANZ XR are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants, such as methotrexate or corticosteroids.
“If a serious infection develops, interrupt XELJANZ / XELJANZ XR until the infection is controlled.
Reported infections include:
Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before XELJANZ / XELJANZ XR use and during therapy. Treatment for latent infection should be initiated prior to XELJANZ / XELJANZ XR use.
Invasive fungal infections, including cryptococcosis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.
The most common serious infections reported with XELJANZ included pneumonia, cellulitis, herpes zoster, urinary tract infection, diverticulitis, and appendicitis. Avoid use of XELJANZ / XELJANZ XR in patients with an active, serious infection, including localized infections, or with chronic or recurrent infection.
In the UC population, XELJANZ 10 mg twice daily was associated with greater risk of serious infections compared to 5 mg twice daily. Opportunistic herpes zoster infections (including meningoencephalitis, ophthalmologic, and disseminated cutaneous) were seen in patients who were treated with XELJANZ 10 mg twice daily. Page 4 of 10
The risks and benefits of treatment with XELJANZ / XELJANZ XR should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection, or those who have lived or traveled in areas of endemic TB or mycoses. Viral reactivation including herpes virus and hepatitis B reactivation have been reported. Screening for viral hepatitis should be performed in accordance with clinical guidelines before starting therapy.
Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with XELJANZ / XELJANZ XR, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.
Caution is also recommended in patients with a history of chronic lung disease, or in those who develop interstitial lung disease, as they may be more prone to infection.
Lymphoma and other malignancies have been observed in patients treated with XELJANZ. Epstein Barr Virus-associated post-transplant lymphoproliferative disorder has been observed at an increased rate in renal transplant patients treated with XELJANZ and concomitant immunosuppressive medications.
Consider the risks and benefits of XELJANZ / XELJANZ XR treatment prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC) or when considering continuing XELJANZ / XELJANZ XR in patients who develop a malignancy.
Malignancies (including solid cancers and lymphomas) were observed more often in patients treated with XELJANZ 10 mg twice daily dosing in the UC long-term extension study.
Other malignancies were observed in clinical studies and the post-marketing setting including, but not limited to, lung cancer, breast cancer, melanoma, prostate cancer, and pancreatic cancer. NMSCs have been reported in patients treated with XELJANZ. In the UC population, treatment with XELJANZ 10 mg twice daily was associated with greater risk of NMSC. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
Clearly Xeljanz is serious medicine.
Why so many bad side effects? Xeljanz treats arthritis by suppressing the patient’s immune system, by doing so it allows other diseases to take hold.
How much does Pfizer know? How much are Pfizer sales reps still pushing higher dosages or pushing the medication for off label uses? Those questions will be asked in the upcoming lawsuits and investigations.
Xeljanz lawsuit cases are already being filed against the company. And last week’s black box warnings will push even more people to step forward.
Have You Suffered a Pulmonary Embolism or Other Problem from Xeljanz?
Medications have side effects. But pharmaceutical companies still have an obligation to make their products as safe as possible, to adequately warn patients and to properly educate physicians on the safety and proper doses / uses of their products.
Many Americans think that FDA approval of a drug is the final word. It isn’t. Although the FDA requires testing and efficacy studies, it mostly relies on the pharmaceutical companies to police themselves. That is why we weren’t shocked when the February 2019 report highlighted serious concerns while at the same time Pfizer was claiming its results were different.
When companies fail to properly test their drugs or recommend their use for diseases without FDA approval, patients often suffer and sometimes die. And when that happens, the pharmaceutical maker can be held financially responsible.
Damages Available in a Xeljanz Lawsuit
If you suffered a pulmonary embolism or deep vein thrombosis or if a loved one died from complications associated with Xeljanz (tofacitinib), you may be entitled to significant monetary damages:
Damages in a Xeljanz lawsuit can include:
- Medical expenses and hospital bills
- Prescription medications
- Future medical expenses
- Lost wages
- Future lost wages and diminished earnings capacity
- Pain and suffering
- Out of pocket expenses
- In death cases – burial expenses and lost earnings
The Xeljanz lawsuit (tofacitinib) cases are in their infancy. As discovery progresses, we will learn what exactly Pfizer knows and when they learned.
We know the Europeans did anot pprove the drug until much later (2017) and then in a much lower 5mg twice daily dose and only when other drugs didn’t work.
Our investigation right now is limited to patients:
- Treated for arthritis with Xeljanz or its extended release version
- Taking 10mg, twice daily
- Suffering from death, pulmonary embolism, deep vein thrombosis or stroke
To learn more or see if you have a Xeljanz lawsuit claim, contact us online, by email or by phone at 202-800-9792. We are a nationwide boutique law firm that has prosecuted cases in over 40 states. We also invite you to visit our dangerous drug lawsuit page that better explains the process of suing for injuries caused by dangerous drugs and why you should not rely on your local personal injury lawyer for help.
**Seeking Pfizer Whistleblowers
We got our start by representing whistleblowers including several pharma workers tired of the greed and dangerous drugs being pushed by their employers.
Since Xeljanz is a medication covered by Medicare, any inside information about dangerous off label use marketing or adulterated products may make you eligible for a cash whistleblower reward.
Even if you are not interested in a reward, we still want your help… and its okay to remain anonymous. Any information you provide can help us help patients. Use our contact information above. All whistleblower inquiries are protected by the attorney – client privilege and kept strictly confidential.