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Olumiant and Those JAK Inhibitors Drug Safety Issues: Eli Lilly’s “Spin”

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Olumiant (baricitinib), Xeljanz (tofacitinib), and Rinvoq (upadacitinib) are the three Janus kinase (JAK) inhibitors currently approved by the FDA for the treatment of arthritis and other inflammatory conditions. In September 2021 the FDA announced a JAK inhibitors drug class label change. Specifically, the FDA is requiring revisions to the “Black-Box” warnings for Olumiant, Xeljanz,  and Rinvoq to include information about the increased risk of serious side effects associated with JAK inhibitors drugs.

Olumiant is an Eli Lilly drug, and this pharmaceutical company is attempting to distinguish the safety profile of their respective JAK inhibitors drug product from the JAK inhibitors drug class safety issues flagged by the FDA.

For example, there is this Lilly News Release document, “OLUMIANT® Long-Term Safety Profile Established Up to 9.3 Years in Integrated Analysis of More Than 3,700 Patients with Rheumatoid Arthritis”, which was issued on November 9, 2021.

For some analysis and context about that November 2021 Olumiant press release from Eli Lilly, we refer you to this Fierce Pharma news report, “Eli Lilly touts long-term safety data for Olumiant amid classwide scrutiny on JAK meds”, published on November 10, 2021.

In the new pooled analysis, the incidence of major adverse cardiovascular events (MACE) for Olumiant was 0.51 per 100 patient-years of exposure, which Lilly said falls within the range in the general rheumatoid arthritis population as described in epidemiological studies….

In a subgroup of patients over 50 years old who had at least one existing heart risk factor, the incidence rate of MACE [for Olumiant] was higher at 0.77 per 100 patient-years.

That latter patient population was targeted in Pfizer’s postmarketing safety study for Xeljanz. As [Pfizer] disclosed earlier this year, Xeljanz’s MACE incidence rate was 0.91 per 100 person-years at the 5 mg dose….

As for the cancer rates, the age-adjusted number for Olumiant was 0.92 per 100 person-years, which Lilly again said appeared similar to the general U.S. population. In the Pfizer trial, Xeljanz recorded a cancer rate of 1.13….

The FDA is still considering the details of the JAK inhibitors drug class “Black-Box” warnings label change it announced in September 2021.

Our law firm is investigating possible drug injury lawsuits for patients who used Olumiant, Rinvoq, or Xeljanz and then suffered serious side effects associated with JAK inhibitors drugs. These include heart problems such as heart attacks, strokes, pulmonary embolism (PE), and deep vein thrombosis (DVT), as well as cancers such as lymphoma and lung cancer.

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Two Padcev-induced TEN / SJS Cases Where Patient Died From Their Padcev Side Effects

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We continue to monitor the medical literature for any Padcev skin reaction case report involving toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS). In this post, we cover two Padcev-induced TEN / SJS cases where the patient died from their Padcev side effects.

We start with a Case Report item published by the Journal of The American Academy of Dermatology (JAAD), “A rare presentation of enfortumab vedotin–induced toxic epidermal necrolysis”. This man presented to the hospital for the evaluation of a rash that developed shortly after his day 8 infusion of Padcev. In more detail, from the JAAD Case Report:

The patient was scheduled to receive [Padcev (enfortumab vedotin)] on days 1, 8, and 15 of a 28-day cycle at the M.D. Anderson Cancer Center. He tolerated day 1 of his medication well; however, after his day 8 infusion, an erythematous rash with associated skin sloughing developed on <20% of his body…. @His medication list was reviewed for the identification of a potential cause of SJS/TEN…. Based on his recent initiation of [Padcev (enfortumab vedotin)] and his rapid-onset development of the rash, the drug was deemed to be the cause and was discontinued, and he was started on a topical steroid. A biopsy was performed, and the pathology revealed interface dermatitis with central areas of full-thickness epidermal necrosis, consistent with an SJS/TEN overlap (Fig 3).

… His rash progressed to involve >30% of his skin, and he was diagnosed with TEN…. The patient died 20 days after admission on February 27, 2020.

Our next Padcev skin reaction case report was found in an article published by the medical journal Frontiers in Oncology. The lengthy title of that article is “Case Report: Enfortumab Vedotin for Metastatic Urothelial Carcinoma: A Case Series on the Clinical and Histopathologic Spectrum of Adverse Cutaneous Reactions From Fatal Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis to Dermal Hypersensitivity Reaction”. This Padcev-induced TEN case report concerns a 71-year-old male, whose case was described in relevant part as follows:

He received [Padcev (enfortumab vedotin)] 1.25 mg/kg on days 1 and 8 of the first cycle. Within 24 h of the day 8 infusion [of Padcev], he experienced diffuse pruritus. Four days after the infusion, he presented to the emergency department with fevers to 101°F and mouth pain but was otherwise hemodynamically stable with unremarkable cardiac and pulmonary exams. His dermatologic exam on admission revealed a small ulceration on the right lateral upper lip, well-demarcated erythema of the inferior tongue tip, and tender erythema of the axillae, flanks, inguinal region, and soles of feet…. The clinical and histologic findings were compatible with early changes of SJS/TEN….

ICU transfer with IV methylprednisolone treatment was initiated on day 3 for involvement of 18% total body surface area and high SCORETEN of 7…. He subsequently was transferred to the burn unit at a nearby hospital, but the patient expired several days later.

We are investigating Padcev-induced TEN / SJS cases for patients who suffered these serious and sometimes fatal Padcev side effects as possible drug injury lawsuits to be filed against Astellas Pharma US, Inc., the manufacturer of Padcev.

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Drug Regulator MHRA Imposes More Xeljanz Use Limitations in October 2021

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In this Drug Safety Update document, “Tofacitinib (Xeljanz▼): new measures to minimise risk of major adverse cardiovascular events and malignancies”, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) took new regulatory action regarding the Xeljanz risk of cardiovascular events as well as the Xeljanz risk of cancers, or malignancies.

Issued by the MHRA on October 6, 2021, this document states that Xeljanz should not be used by these patients in the groups identified below unless there is no suitable drug treatment alternative:

  • people older than 65 years of age;
  • people who are current or past smokers;
  • people with other cardiovascular risk factors, such as diabetes or coronary artery disease;
  • people with pre-existing cancer or malignancy risk factors.

About the Xeljanz risk of cardiovascular events, we find this important information in the October 2021 MHRA Xeljanz document:

Predictive factors for development of myocardial infarction (fatal and non-fatal) were identified using a multivariate Cox model with backward selection. These factors were age older than 65 years, male sex, current or past smoking, history of diabetes, and history of coronary artery disease (which includes past myocardial infarction, coronary heart disease, stable angina pectoris, or past coronary artery procedures).

And about the Xeljanz risk of cancers, that document provides this information:

Predictive factors for development of malignancies (excluding non-melanoma skin cancer) were identified using a multivariate Cox model with backward selection. These were age older than 65 years and current or past smoking.

We will watch for possible additional drug regulatory actions due to the Xeljanz risk of cardiovascular events as well as the Xeljanz risk of cancers, and report significant developments here.

Our law firm is handling Xeljanz drug injury lawsuits for patients with cases of Xeljanz causing heart problems such as heart attacks, strokes, pulmonary embolism (PE), and deep vein thrombosis (DVT), as well as Xeljanz causing lymphoma, lung cancer, and other cancers.

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Imbruvica Heart-Related Side Effects and Cardiotoxicity Safety Issues

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In this article, we point out a few of the medical news reports about heart-related Imbruvica side effects that have been published in the past 12 months.

First, there is this November 2020 Healio article, “Link between ibrutinib-related hypertension, heart problems necessitates close monitoring”, which provides some key findings from several different medical journal articles about research focused on heart-related Imbruvica side effects. From the Conclusions part of that Healio article:

[Chronic lymphocytic leukemia (CLL)] is a disease of the elderly. Real-world evaluations suggest many patients initiated on [Imbruvica (ibrutinib)] have significant comorbidities, many of them cardiovascular.

Hypertension — an important risk factor for the development of atrial fibrillation — may occur at a much higher rate in real-world practice settings than reported in clinical trials.

Patients should be monitored for the development of new or worsened hypertension, particularly early in the therapy course.

Second, we have a June 2021 report from ThePharmaLetter, “Imbruvica: new safety signal for use with rituximab and ACE inhibitors” about the European Medicines Agency (EMA) issuing a new safety signal for Imbruvica with rituximab:

As part of its advice on safety-related aspects to other European Medicines Agency committees, the Pharmacovigilance Risk Assessment Committee (PRAC) last week discussed a direct healthcare professional communication (DHPC) containing important safety information for Imbruvica (ibrutinib).

This DHPC aims to inform healthcare professionals about a new safety signal of sudden or cardiac death with Imbruvica when used in combination with rituximab and angiotensin-converting enzyme (ACE) inhibitors. The signal was recognized following a review of the findings of a clinical trial….

Third, and most recent, is a September 2021 MedPage Today news report, “Ibrutinib for CLL Tied to Higher Heart Risks vs Chemotherapy”, about there being increased risks for atrial fibrillation, bleeding, and heart failure seen in a Canadian cohort of patients using Imbruvica:

Use of the Bruton tyrosine kinase (BTK) inhibitor ibrutinib (Imbruvica) was linked with cardiovascular risks in patients with chronic lymphocytic leukemia (CLL), according to results of a population-based cohort study.

Over 3 years, the incidence of atrial fibrillation (AF)-related healthcare contact was 22.7% in patients treated with [Imbruvica (ibrutinib)] compared with 11.7% in patients who received chemotherapy, risk of hospital-diagnosed bleeding was 8.8% and 3.1%, respectively, and risk of heart failure (HF) was 7.7% and 3.6%, reported Husam Abdel-Qadir, MD, PhD, of Women’s College Hospital in Toronto, and colleagues.

We will continue to monitor the medical literature for more reports of heart-related Imbruvica side effects, as well as watch for possible regulatory action by the FDA or the EMA.

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Possible New Xeljanz Side Effect: Peripheral Neuropathy

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As reported in this Letters to the Editor item, “Tofacitinib and Risk of Peripheral Neuropathy? Experience of 2 Cases in Patients With Rheumatoid Arthritis”, patients treated with Xeljanz (tofacitinib) for their rheumatoid arthritis (RA) may be at risk of neurological adverse events, such as Xeljanz-related peripheral neuropathy. That item about neurological Xeljanz adverse event reports was published in the March 2021 edition of JCR: Journal of Clinical Rheumatology.

According to the FDA, as of September 2021 some of the generally recognized Xeljanz side effects and Xeljanz adverse events are:

Heart Attacks
Myocardial Infarction (MI)
Strokes — Ischemic / due to a blood clot
Deep Vein Thrombosis (DVT)
Pulmonary Embolism (PE)
Arterial Thrombosis
Lymphoma
Lung Cancer
Other Cancers
Death

We will continue to monitor the medical literature for developments regarding serious Xeljanz-related peripheral neuropathy and other Xeljanz adverse event reports.

At the present time, our law firm is investigating Xeljanz lawsuits filed against Pfizer, the pharmaceutical company responsible for Xeljanz, for patients with cases of Xeljanz causing heart problems such as heart attacks, strokes, pulmonary embolism (PE), and deep vein thrombosis (DVT), as well as Xeljanz causing lymphoma, lung cancer, and other cancers. Please feel free to contact us if we can help you or someone you know with a Xeljanz drug injury case.

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Padcev Linked to SJS and TEN: From No Warning to “Black Box” in Less Than 2 Years

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We are going to look at how the Padcev drug label went from having no warning about Padcev skin side effects Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) when approved by the FDA in December 2019 to the Padcev drug label having a “Black-Box” warning about the SJS and TEN skin side effects in July 2021, less than 2 years after Padcev came on the market

To start, Padcev (enfortumab vedotin-ejfv), an injection drug for intravenous use, was approved by the FDA in December 2019 for the treatment of certain adult patients with locally advanced or metastatic urothelial cancer (mUC), a type of bladder cancer.

Padcev skin side effects Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are serious skin reactions that can be life-threatening and even fatal. In people who have developed SJS), the more severe skin reaction TEN is diagnosed when more than 30% of the skin surface is affected and the moist linings of the body (mucous membranes) have extensive damage. Put otherwise, toxic epidermal necrolysis (TEN) is a severe form of Stevens-Johnson syndrome (SJS). And, significantly, TEN is such a serious skin reaction that it can be fatal, causing patient deaths in some situations.

In the initial Padcev drug label (“Revised: 12/2019”) there was a warning about general, low-level Padcev skin side effects in the Warnings and Precautions section at 5.4 Skin Reactions.

The first label change to add warnings for the Padcev skin side effects Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) came in March 2021. From the “Revised: 3/2021” Padcev drug label at 5.1 Skin Reactions:

Severe cutaneous adverse reactions, including fatal cases of Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN) occurred in patients treated with PADCEV. SJS and TEN occurred predominantly during the first cycle of treatment but may occur later.

But only four months later, in July 2021, the FDA mandated increased warnings about the Padcev skin side effects Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), in the form of a so-called “Black Box” warning with the bolded title WARNING: SERIOUS SKIN REACTIONS

Our law firm is investigating cases for patients who have suffered the Padcev skin side effects Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) as possible drug injury lawsuits to be filed against Astellas Pharma US, Inc., the manufacturer of Padcev.

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Elmiron and Maculopathy: Two Recent Medical Articles About an Elmiron Vision Side Effect

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In this post, we look at some relatively recent research regarding the still-emerging drug safety issue of Elmiron and maculopathy, i.e., maculopathy is an Elmiron vision side effect.

According to “Screening needed for pentosan polysulfate sodium-associated maculopathy”, published on September 2, 2021, by Ocular Surgery News:

In most cases, retinal findings do not appear until a patient has been on [Elmiron] for 10 to 15 years, according to Elliott Sohn, MD, of the University of Iowa. Because patients generally start to present with interstitial cystitis in their 40s, once they start to develop maculopathy, it is easily confused with macular degeneration.

“The maculopathy appears to be dose dependent and most often seen when the patient has been on [Elmiron] for a total cumulative dose of 1,500 g,” Sohn said. “A lot more research needs to be done to better understand why and how this is happening, as well as the prevalence of it.”

Two medical journal articles published in 2021 have presented some of this needed research about Elmiron and maculopathy.

First, from the Abstract for this study report published in the September 1, 2021 edition of The Journal of Urology, “PD01-09 PATIENT PERCEPTION OF OCULAR RISK IN PENTOSAN POLYSULFATE USE FOR INTERSTITIAL CYSTITIS”:

  • CONCLUSIONS: While the mechanism of maculopathy in [Elmiron] use is not fully understood, this risk must be weighed against its potential benefit as a treatment for interstitial cystitis. Physicians should counsel patients on risk of ocular complication in long term and high dose [Elmiron] use, and consider alternative therapies and early ophthalmologic referral in patients with lifetime cumulative doses [of Elmiron] greater than 500 g.

Second, from the Abstract for this study report published in the February 11, 2021 edition of the medical journal Clinical Ophthalmology, “Maculopathy Secondary to Pentosan Polysulfate Use: A Single-Center Experience”:

  • Conclusion: A novel drug-induced maculopathy has been associated with [Elmiron] use with a distinct clinical constellation that can be accurately identified with multimodal imaging.

Of course, we will continue to monitor this still-emerging drug safety issue of Elmiron and maculopathy.

Our law firm is investigating possible Elmiron drug injury lawsuits for cases of an Elmiron vision side effect such as retinal pigmentary changes and pigmentary maculopathy resulting in vision loss.

[View article in full at original source]

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Xeljanz: Heart Attacks, Strokes, Cancers, Blood Clots, and Deaths – Updated FDA Warnings 2021

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On September 1, 2021, we saw new FDA Xeljanz warnings about the increased risks of heart attacks, strokes, cancer, blood clots, and deaths. These Xeljanz drug safety problems have been associated with all doses of Xeljanz (5 mg tablet and 10 mg tablet) and Xeljanz XR (11 mg tablet and 22 mg tablet).

This September 2021 document, “FDA requires warnings about increased risk of serious heart-related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions“, begins with the following new information:

Based on a completed U.S. Food and Drug Administration (FDA) review of a large randomized safety clinical trial, we have concluded there is an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death with the arthritis and ulcerative colitis medicines Xeljanz and Xeljanz XR (tofacitinib). This trial compared Xeljanz with another type of medicine used to treat arthritis called tumor necrosis factor (TNF) blockers in patients with rheumatoid arthritis. The trial’s final results also showed an increased risk of blood clots and death with the lower dose of Xeljanz. A prior DSC based upon earlier results from this trial, reported an increased risk of blood clots and death only seen at the higher dose.

In more detail, from the Data Summary section of the above-referenced September 2021 document, here are the most recent FDA findings as regards various Xeljanz side effects:

There was an increased risk of death, MACE, malignancies, and thrombosis associated with both regimens of Xeljanz. The data showed evidence of a dose-dependent increased risk for [major adverse cardiovascular events (MACE) — defined as cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke], all-cause mortality, and thrombosis at both doses of Xeljanz when compared to treatment with [tumor necrosis factor (TNF) blockers]. Additionally, the data showed evidence of a non-dose-dependent increased risk for malignancy excluding [nonmelanoma skin cancer (NMSC)] at both doses of Xeljanz when compared to TNF blockers. Lymphomas and lung cancers were observed at a higher rate in patients treated at both doses of Xeljanz compared to those treated with TNF blockers. In particular, a higher rate of lung cancers was observed in current or past smokers treated with Xeljanz. Current or past smokers had an additional increased risk of overall cancers.

We will continue to monitor the Xeljanz drug safety problems of serious side effects and adverse drug reactions suffered by some patients who were using Xeljanz as prescribed by their doctor.

Further, we expect these new FDA Xeljanz warnings in September will lead to the filing of more Xeljanz lawsuits against Pfizer for cases of Xeljanz causing heart problems such as heart attacks and strokes as well as Xeljanz causing cancers.

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Tasigna Drug Injury Lawsuits Federal Court MDL Consolidation Order

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There is a newly created Tasigna multi-district litigation (MDL) for those Tasigna drug injury lawsuits filed in the federal court system.  We get some of the reasoning for this consolidation of Tasigna side effects cases from the August 10, 2021, JPML Transfer Order issued for IN RE: TASIGNA (NILOTINIB) PRODUCTS LIABILITY LITIGATION, MDL No. 3006:

All actions can be expected to share factual questions arising from allegations that Novartis failed to appropriately warn of the risks that use of Tasigna may cause severe atherosclerotic injuries. Despite warning doctors and patients in Canada of the heightened risks of atherosclerotic-related conditions, plaintiffs contend that Novartis concealed its knowledge of Tasigna’s unreasonably dangerous risks from plaintiffs, other consumers, and the medical community in the U.S. All plaintiffs bring claims for strict products liability – failure to warn and negligence. Issues of general causation and Tasigna’s labeling and regulatory history appear common to all actions….

Novartis opposes centralization, arguing that there are too few actions to justify centralization and that informal cooperation is feasible. We are not persuaded by these arguments…. [Footnotes omitted.]

As we previously, in early June 2021, the New Jersey Supreme Court consolidated some other Tasigna drug injury lawsuits filed against Novartis for pretrial proceedings as part of a New Jersey state court multi-county litigation (MCL).

Here is what one needs to know about these Tasigna drug injury cases. Since at least 2013 Tasigna has been linked to atherosclerosis, which is a disease that results in thickening, hardening, and blocking of the arteries due to the buildup of plaque. The following medical conditions are considered to be atherosclerosis-related diseases:

Peripheral Arterial Disease (PAD) involving lower limbs;
Peripheral Arterial Occlusive Disease (PAOD);
Ischemic Heart Disease; and,
Ischemic Cerebrovascular Disease.

In turn, these serious medical conditions can result from, or are secondary to, atherosclerosis-related diseases:

Strokes / Cerebrovascular Accidents (CVA)
Heart Attacks / Myocardial Infarctions (MI)
Lower Limbs Amputations
Aneurysms, e.g., Brain Aneurysm
Deep Vein Thrombosis (DVT)
Pulmonary Embolism (PE)
Chronic Kidney Disease
Kidney / Renal Failure

As such, these various medical conditions are considered to be Tasigna side effects.

For the past few years, well before these recent Tasigna MDL and Tasigna MCL orders, we have been investigating Tasigna drug injury lawsuits against Novartis for patients who were diagnosed with an atherosclerosis-related disease and thereafter suffered subsequent Tasigna side effects, such as an amputation, aneurysm, stroke, or heart attack.

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Drug Injury Lawsuits: List of Some Cases Filed in First Half of 2021

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A drug injury lawsuit is a personal injury case or a wrongful death case involving a serious drug side effect or a severe adverse drug reaction.

Here are some of the prescription medications for which drug injury lawsuits were filed against the responsible pharmaceutical company in the first half of 2021:

  • Xeljanz
  • Beovu
  • Elmiron
  • Injectafer
  • Belviq
  • Ocaliva
  • Uloric
  • Invokana / Farxiga / Jardiance
  • Tasigna
  • Actemra

The best way to make a claim for legal compensation for an injury or death caused by a serious drug side effect or a severe adverse drug reaction is by filing an individual drug injury lawsuit (not a class action).

It is important to know that each state has a statute of limitations that determines the time period within which one may file a drug injury lawsuit. For example, in some states a personal injury claim must be filed within 1 or 2 years from the date that the serious drug side effect or the severe adverse drug reaction is diagnosed. Likewise, some states require that a wrongful death claim be filed within 1 or 2 years from the date of a death which was caused by a serious drug side effect or a severe adverse drug reaction. Be aware that these statutes of limitations, or deadlines, vary from state to state.

Because of these strict filing deadlines, you should not delay in finding an experienced drug injury lawyer when you may have a possible case involving a serious drug side effect or a severe adverse drug reaction.

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Law Offices of Thomas J. Lamb, P.A.
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