Xeljanz Side Effects Include Heart Attacks, Strokes, and Cancers
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Our law firm is investigating Xeljanz lawsuits filed against Pfizer, the pharmaceutical company responsible for Xeljanz — and, we contend, serious Xeljanz side effects. Related to this, there is a possible Xeljanz recall following the latest FDA regulatory action.
To start, it is unusual the FDA pointed out, again, in 2021 that there are cases of Xeljanz causing heart problems and Xeljanz causing cancer. We say that because those serious Xeljanz side effects were already “highlighted” by means of the Black Box Warning which was added to the Xeljanz drug label back in 2019. As such, it is possible the FDA may mandate a Xeljanz recall in the future, but this remains to be seen. Regardless, it is likely there will be Xeljanz lawsuits filed on behalf of patients who have suffered Xeljanz side effects such as heart attacks, strokes, and cancers.
This FDA Drug Safety Communication, “Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib)“, provides the latest details about these two Xeljanz safety issues: (1) Xeljanz causing heart problems; and (2) Xeljanz causing cancer.
As background, in 2012, Pfizer’s Xeljanz was approved by the FDA to treat adults with rheumatoid arthritis, and in 2017 the drug was approved by the FDA to treat psoriatic arthritis. Shortly thereafter, in 2018, the drug was approved by the FDA to treat ulcerative colitis. It is also indicated for the treatment of adult patients with moderately to severely active rheumatoid or active psoriatic arthritis who have had an inadequate response to certain other drugs.
Again, we remark about this noteworthy February 2021 FDA Xeljanz Drug Safety Communication being issued on top of the prior Xeljanz Black Box Warning. We think it will result in new Xeljanz lawsuits being filed for patients against Pfizer, as well as the prospect of a Xeljanz recall mandated by the FDA.
Some of the adverse drug events and side effects related to Xeljanz are:
- Heart Attacks
- Myocardial Infarction (MI)
- Strokes — Ischemic / due to a blood clot
- Deep Vein Thrombosis (DVT)
- Pulmonary Embolism (PE)
- Arterial Thrombosis
Our law firm is investigating possible Xeljanz lawsuits for patients, whether or not there is a Xeljanz recall, and we would like to help you or someone you know with such a case.
We encourage you to submit a Xeljanz Case Evaluation Form online – it is free, confidential, and there is no obligation. Or, if you prefer, call our toll-free number, (800) 426-9535, to speak directly to attorney Tom Lamb about a possible drug injury case. Either way, you will get Mr. Lamb’s impressions — not an intake person, a paralegal, nor some other lawyer — about your case based on his many years of experience.
Most Recent Article About Xeljanz
After the January 2021 release of limited data from a Xeljanz safety trial which often goes by its short name, ORAL Surveillance, some experts raised the possibility that there may consequences for other drugs in the Janus kinase (JAK) inhibitors class of drugs. Specifically, some have asked whether the FDA may extend its new Xeljanz warnings about Xeljanz causing heart problems and Xeljanz causing cancer to those other drugs.
Besides Xeljanz, there are two other JAK inhibitors approved by the FDA:
- Olumiant (baricitinib) from Eli Lilly & Co.; and,
- Rinvoq (upadacitinib) from AbbVie.
To read more of this article, click below:
This February 4, 2021, FDA Drug Safety Communication, “Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib)”, announce the new Xeljanz warnings. It is the ORAL Surveillance Xeljanz safety trial data that is the basis for those new Xeljanz warnings as well as some Xeljanz drug safety alerts issued by the FDA during the past few years.
For some commentary on this Xeljanz safety trial, which started in March 2104 and was completed in July 2020, we go to this February 16, 2021, Healio Rheumatology article, “‘We need to see the data’: FDA’s Xeljanz safety warning stirs concerns for JAK inhibitors”:
[Stanley Cohen, MD, clinical professor in the department of internal medicine at the University of Texas Southwestern Medical School, and medical codirector of the Metroplex Clinical Research Center, told Healio Rheumatology] the fact that ORAL Surveillance was a head-to-head trial suggests there is “certainly a signal” for major cardiovascular events and cancer with [Xeljanz (tofacitinib)].
“I do think these results are serious,” Cohen said. “I think it’s something we have to look at critically, and again, with just the topline — what can you say? We need to look at all the data and better understand the data.
As mentioned above, the February 2021 FDA safety alert about Xeljanz having increased risks for serious heart-related problems and cancers raises the issue of whether all JAK inhibitors share these side effect risks:
According to Cohen, Pfizer’s results with Xeljanz indicate that other companies that produce JAK inhibitors should likely go back and examine their clinical trial programs, selecting out those patients with the same risk factors to see if there was any imbalance in MACE or malignancies.
As such, besides just watching for more data from the Xeljanz safety trial showing an increased risk of serious heart-related problems and cancer associated with Xeljanz, we will look for any indication that the new Xeljanz warnings might be added to Olumiant and Rinvoq, also.[View article in full at original source]
Earlier articles about Xeljanz by attorney Tom Lamb on the Side Effects Blog:
- Xeljanz 2021 FDA Warnings: Xeljanz Causing Heart Problems and Xeljanz Causing Cancer
- Xeljanz Side Effects Include Blood Clots, Pulmonary Embolism, And Serious Infections
- Xeljanz Should Be Used With Caution In Patients At High Risk Of Blood Clots
- Xeljanz FDA Drug Safety Communication About Increased Risks of Blood Clots And Death
- Serious Side Effects For Xeljanz 10 mg Dose Leads To European Drug Safety Regulatory Action
- Xeljanz Used For Ulcerative Colitis May Increase Risk Of Pulmonary Embolism
More articles about Xeljanz on our Drug Safety Developments website:
- Xeljanz Safety Trial Results Which May Lead to Xeljanz Recall
- Will There Be a Xeljanz Recall in the Future?