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FDA Issues New Xeljanz Warning

FDA Issues New Xeljanz Warning

March 2, 2021 | Pharmaceutical Litigation

For the third time in two years, the Food and Drug Administration has issued a safety warning about Pfizer’s powerful and popular arthritis/UC medicine. The latest warning is the strongest and most comprehensive one yet.

The FDA says that doses as small as 5mg per day could lead to cancer and heart problems, particularly among older adults.

These latest warnings come after more extensive review of the 2012 post-marketing safety study data collected by the FDA.

These trials did not end until 2020. Even now, only topline results, mostly from Pfizer and FDA press releases, are available.

So, more bad news may be coming. “It’s hard to live by release alone,” remarked Dr. Kevin Winthrop, director of the University of Oregon’s Center for Infectious Disease Studies. “To be honest, it’s hard to know what to think. We need to see the data in the analysis,” he added.

Leading rheumatologists say the latest revelations cast a serious cloud over the safety of powerful drugs like Xeljanz which have not been extensively studied.

Xeljanz’s Side Effects

Pfizer promoted Xeljanz, which is a JAK (Janus Kinase) inhibitor, as a powerful upgrade over Tumor Necrosis Factor (TNF) inhibitors.

Indeed, JAK blocks certain inflammation-causing enzymes, while TNF filters them.

Additionally, JAK is an oral medication, whereas TNF usually requires an injection. Pfizer aggressively marketed this aspect of Xeljanz as well.

But there is a dark side.

Because it is so much stronger than TNF, Xeljanz’s JAK has been linked to serious side effects, most notably blood clot issues like Deep Vein Thrombosis and Pulmonary Embolisms.

Both conditions are life-threatening if not treated promptly and properly.

The scary part is that many DVT patients have no idea they are sick until their conditions reach critical stages.

And, PE usually comes on suddenly and without warning, making it difficult to get the help needed when it’s needed.

Researchers fear that the more studies they do, the worse news they will uncover.

Harvard Medical School’s Dr. Rishi J. Desai warned that “Our understanding of the safety profile of JAK inhibitors is evolving.”

Moreover, the DVT and PE issue “is only one potential adverse event in the risk-benefit profile,” he added.

Legal Issues

Even when negative studies appear, drug companies like Pfizer are often able to suppress their findings.

Broadcast and other media outlets rely heavily on drug advertisements for revenue. It’s human nature to avoid biting the hand that feeds you.

So, with just a little indirect pressure, Pfizer can usually move Page 1 headlines all the way back to Page 8 or 10.

As a result, many victims have no idea their illnesses are connected to a specific drug. The delayed discovery rule preserves these victims’ legal rights.

This doctrine suspends the two-year statute of limitations until victims know the full extent of their injuries and link those injuries to the defendant’s dangerous product or wrongful act. But this rule is complex.

Assume Peter took Xeljanz for a few months in 2020 to deal with an ulcerative colitis flare-up. Pfizer did not alter the warning label until 2021.

By that time, Peter was no longer taking Xeljanz, so he did not see the warning. In 2022, Peter’s slow-developing DVT comes to a head, and he almost dies.

A year later, in 2023, he stumbles upon an article linking Xeljanz to DVT and related issues.

Pfizer would almost certainly argue that the two-year limitations period bars Peter’s legal action, since he took the drug and developed a blood clot in 2020.

But he did not know about his illness until 2022, and he did not know about the Pfizer connection until 2023.

Therefore, a New York personal injury attorney has until 2025 to file a damages claim on behalf of Peter.

How You Can Make Things Better

Fundamentally, a dangerous drug claim is not about compensation, although the compensation is possibly substantial, and most victims need every penny of it.

Emergency conditions like DVT often trigger tens of thousands of dollars in medical bills which health insurance companies refuse to pay.

A dangerous drug claim is about more than money. These claims hold companies responsible when they intentionally put profits before people.

Generally, these companies know about the elevated risk, yet they are unwilling to add a simple disclaimer to the label. They are afraid that such a warning will reduce sales.

Dangerous drug claims give you a chance to be part of the solution and make drugs safer for everyone.

Because of their intentional misconduct, juries usually order these companies to pay substantial punitive damages. Money is the only language that companies like Pfizer speak.

Only an eye-popping amount of damages convinces them to change the way they do business.

Using Xeljanz could lead to serious injury. For a free consultation with an experienced personal injury attorney, contact Napoli Shkolnik, PLLC. We do not charge upfront legal fees and handle these cases nationwide.

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