FDA Xeljanz Safety Evaluation Timeline

What is Xeljanz?

Xeljanz is a medication intended to treat moderate-to-severe forms of rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. It is an immunosuppressant with the active ingredient tofacitinib and is part of the class of drugs known as Janus kinase (JAK) inhibitors.

How Does Xeljanz Work?

Xeljanz works by decreasing a substance called cytokines. Cytokines are proteins that help control the immune system. People with rheumatoid arthritis make more cytokines than needed, which leads to inflammation and pain. Xeljanz disrupts cell signals in the Janus kinase (JAK) pathways to decrease the production of cytokines.

Background on Xeljanz

The U.S. Food and Drug Administration (FDA) approved the medication in 2012 for rheumatoid arthritis patients who were not responding to other medications on the market at the time. In 2017, the FDA expanded its approval of Xeljanz and allowed the drug to be prescribed to patients with psoriatic arthritis, a condition that causes joint swelling or pain. The FDA expanded its approval once again in 2018 to treat ulcerative colitis. 

Despite the FDA’s continued approval, however, the FDA had lingering concerns about Xeljanz and ordered a phase IV, post-market study to be conducted by Xeljanz’s manufacturer, Pfizer.

FDA Xeljanz Clinical Safety Study

The FDA’s study began in March 2014 and recently concluded. It included patients with active moderate-to-severe rheumatoid arthritis who were 50 years or older and had at least one cardiovascular risk factor. 

The final results have not been published publicly. However, preliminary data shows that rheumatoid arthritis patients have up to six times the risk of developing a pulmonary embolism when taking the drug’s 10mg dose twice a day compared to patients taking another medication. Patients taking the 5mg twice daily dose have approximately three times the risk of pulmonary embolism.

Pulmonary embolisms are dangerous blood clots that travel to the lungs. Those who suffer from pulmonary embolisms may have an irregular heartbeat, experience chest pain and trouble breathing, feel faint or lightheaded, cough up blood, and experience pain, swelling, tenderness, and redness in parts of the body where the blood formed or traveled. These blood clots can be life-threatening, and those suffering from pulmonary embolisms should seek immediate medical attention. 

The FDA announced that it will continue to review the study’s results and communicate its final conclusions and recommendations in the future.

Xeljanz FDA Safety Clinical Trial Timeline

February 25, 2019: The FDA found that patients taking a dose of 10mg of Xeljanz twice daily may experience an increased risk of developing blood clots in the lungs and therefore issued a safety announcement. Participants in the study were all over 50 years old and each had at least one cardiovascular risk factor. The participants were taking either the 5mg twice daily dose or the 10mg twice daily dose of Xeljanz and were then compared to a similar group of participants on a tumor necrosis factor (TNF) inhibitor. Three days after the safety announcement from the FDA alerting the public to the increased risk of pulmonary embolism and death, Xeljanz’s manufacturer, Pfizer, sent a letter advising healthcare providers of the same risks. 

July 26, 2019: The FDA issued a Black Box Warning for the 10mg twice daily dose of Xeljanz. The black box warning focused on the increased risk of blood clots and death in people with rheumatoid arthritis over 50 years old with at least one cardiovascular risk factor. The black box warning limited the use of the 10mg twice daily dose of Xeljanz to treating ulcerative colitis patients whose condition was not already being sufficiently managed by other medications. As a result, the FDA discontinued the evaluation of the 10mg twice daily dose of Xeljanz in the ongoing clinical trial and switched the participants to the 5mg twice daily dose. 

February 4, 2021: The FDA issued a safety communication warning the public about the initial results from the ongoing Xeljanz study. The initial results found that there is an increased risk of heart-related problems and cancer in patients taking Xeljanz. The trial compared patients taking the 5mg twice daily and 10mg twice daily doses of Xeljanz to patients taking a tumor necrosis factor (TNF) inhibitor. The participants were all over age 50 and had at least one cardiovascular risk factor. Full results from the clinical trial are not yet available. However, the FDA is recommending that patients continue taking Xeljanz as they were prescribed by their physicians but also to consult their healthcare providers if they have questions or concerns.

How GoldenbergLaw Can Help

If you or a loved one suffered harm after taking Xeljanz, contact the Minnesota Xeljanz Attorneys at GoldenbergLaw today for a free consultation. We have provided Gold standard advocacy for more than 30 years! Contact us today, and you can leave the sleepless nights to us!

Judge Denies Defendants’ Preemption Motions In Valsartan MDL

On December 17, 2020, U.S. District Judge Robert B. Kugler ruled that the plaintiffs’ claims are not preempted in the Valsartan contamination multidistrict litigation (MDL). This ruling makes sure that claims against manufacturers, wholesalers, and pharmacies will continue in the MDL over their alleged failure to keep contamination out of Valsartan. 

Specifically, Judge Kugler noted that the defendants failed to take into account the U.S. Supreme Court precedent that the states’ policing powers can supersede federal law if that was the clear intent of Congress.

What is the Preemption Argument from Valsartan Manufacturers?

Valsartan manufacturers have asserted that they were prohibited by federal regulations determined by the U.S. Food and Drug Administration (FDA) from warning consumers about the contamination within the drug. They claimed that they could not alter their manufacturing process without FDA approval in addition to the Food, Drug and Cosmetic Act and the Drug Supply Chain Security Act (DSCSA)’s requirements which they claim can only be enforced by the government. 

Valsartan manufacturers, wholesalers, and pharmacies such as Teva Pharmaceuticals USA Inc., Mylan Pharmaceuticals Inc., AmerisourceBergen, Cardinal Health Inc., CVS and Walgreens all made the preemption argument.

Background on Preemption Arguments

Preemption arguments stem from the Supremacy Clause of the U.S. Constitution. It states that when state and federal law conflict, the federal law preempts (overpowers) state law. In the case of prescription drugs, Congress has allowed the U.S. Food and Drug Administration (FDA) to set the minimum national standards; therefore, their powers are viewed as federal law. The FDA has the primary responsibility to review the safety, efficacy, and labeling of medical products. 

Regarding drug manufacturers, states usually cannot penalize drug manufacturers for not including a warning that the FDA has already deemed to be unnecessary as long as the manufacturer follows all of the FDA’s other guidelines. Therefore, manufacturers cannot be held accountable to differing laws and regulations that may be enacted in 50 different states. 

The federal drug labeling preemption argument is based on the requirement that the brand-name drug has been tested and vetted by the FDA prior to entering the market. Since generic drugs are required by federal law to be a bioidentical drug, the argument is that different warnings are unnecessary and that generic manufacturers therefore cannot be held responsible for failing to provide additional or different warnings regarding their medication.

Injuries from Contaminated Valsartan

Valsartan’s contamination with the probable human carcinogen N-nitrosodimethylamine (NDMA) can create an increased risk for the following cancers: 

  • Bladder Cancer
  • Blood Cancer 
  • Breast Cancer
  • Colorectal / Intestinal Cancer
  • Esophageal Cancer
  • Gastric Cancer
  • Kidney Cancer
  • Liver Cancer
  • Lung Cancer 
  • Pancreatic Cancer
  • Pharyngeal Cancer
  • Prostate Cancer
  • Uterine Cancers 

What Was Judge Kugler’s Reasoning Behind The Ruling?

Judge Kugler explained that Congress’ intent in passing the DSCSA was to protect consumers from exposure to drugs that may be “counterfeit, stolen, contaminated or otherwise harmful” by creating a national system for product tracing. He determined that the DSCSA does not preempt state requirements pertaining to aspects of distributing drugs: “Although the preemption clause seeks to eliminate inconsistent state regulations related to tracing of pharmaceuticals, Congress did not enact the DSCSA in an effort to displace all state law regarding defective pharmaceutical drugs. Under the defendants’ view of the Act, Congress would have barred most, if not all, relief for persons injured by defective pharmaceuticals.”  

Judge Kugler added that there is no danger of inconsistent rulings since the FDA has already researched the cause of the contamination sufficiently to develop an understanding about the chemical processes involved in creating it.

How Does It Impact the Valsartan MDL?

Valsartan MDL Judge Kugler’s rejection of the defendants’ dismissal motion based on the preemption argument is a boost for the plaintiffs in the Valsartan MDL. The personal injury, economic loss, and medical monitoring lawsuits that are at stake in the MDL may continue to move forward due to this ruling. 

GoldenbergLaw Can Help

If you or a loved one has been diagnosed with cancer after taking the blood pressure medication Valsartan, contact the Dangerous Drug Attorneys at GoldenbergLaw for a free consultation. With thirty-four years of experience, we have the knowledge, experience, and compassion to give you the Gold standard of advocacy that you deserve. Contact us today to discuss a free Valsartan lawsuit consultation and leave the sleepless nights to us!