Drug Injury Watch

Past Elmiron Use Linked to Pigmentary Maculopathy and Vision Loss, Again, by Two Recent Medical Studies

Patients with High Levels of Elmiron Use Have More Than a 2-Times Increased Risk of Developing Serious Eye Problems

 

(Posted by Tom Lamb at Drug Injury Watch)

 

Two new medical journal articles provide further support for the fact that past Elmiron use is associated with pigmentary maculopathy and vision loss. Remarkably, according to one medical study, patients with high levels of Elmiron use have more than a 2-times increased risk for getting a diagnosis of pigmentary maculopathy or macular degeneration.

Elmiron (pentosan polysulfate sodium, or PPS) was approved by the FDA way back in September 1996 for the treatment of painful bladder syndrome (interstitial cystitis). In recent years, however, cases of Elmiron-related eye damage have been reported.

It is important to know that a patient does not have to have been using Elmiron regularly right up until the time when their pigmentary maculopathy or macular degeneration was diagnosed in order for those conditions to be considered Elmiron-related eye damage.

The first article, "Pentosan Polysulfate and Vision: Findings from an International Survey of Exposed Individuals", was published in December 2020 by the Retina medical journal. From the Abstract for this article:

• Purpose: To investigate patient-reported visual function in individuals taking [Elmiron (pentosan polysulfate sodium, or PPS)] for interstitial cystitis.
• Results: ... Respondents in the highest [Elmiron (pentosan polysulfate sodium, or PPS)] exposure tertile were more likely to report difficulty with reading small print (adjusted OR 2.29, 95%CI 1.15-4.57) and to have a diagnosis of macular degeneration and/or pigmentary maculopathy (adjusted OR 2.41, 95%CI 1.44-4.03) than unexposed respondents.

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The second article, "Maculopathy Secondary to Pentosan Polysulfate Use: A Single-Center Experience", was published in February 2021 by the Clinical Ophthalmology medical journal. From the Abstract for this article:

• Aim: To investigate the prevalence of retinal pathology in patients with a history of exposure to [Elmiron (pentosan polysulfate sodium, or PPS)].
• Methods: Patients exposed to [Elmiron (pentosan polysulfate sodium, or PPS)] and seen in the ophthalmology clinic at Northwestern University during 1/1/2002 to 1/1/2019 were identified from electronic health records (EHR) by an electronic data warehouse (EDW) search. Visual acuity (VA), reasons for clinic visit, ocular conditions, and duration of exposure to [Elmiron (pentosan polysulfate sodium, or PPS)] were noted....
• Results: A total of 131 patients who were exposed to [Elmiron (pentosan polysulfate sodium, or PPS)] and seen at the Northwestern Ophthalmology clinic were identified in the EHR. Forty patients of 131 had imaging. Patients with imaging or fundus examination suspicious for [Elmiron (pentosan polysulfate sodium, or PPS)] maculopathy were placed into the suspect group. Of the 40 patients that had imaging, 5 (12.5%) had features suspicious for PPS maculopathy. Of the remaining 91, 5 (5.4%) had macular pigmentary changes described on fundus exam. Among the 10 patients in the suspect group, the average duration of [Elmiron (pentosan polysulfate sodium, or PPS)] use was 4.2 years... and the average cumulative dose was 380g....

We are currently investigating possible Elmiron lawsuits for patients with past Elmiron use diagnosed with eye problems such as:

Vision Loss / Blindness
Maculopathy (retinal or pigmentation)
Retinal Pigmentary Endothelium Injury (RPE)
Pigmentation Maculitis
Macular Degeneration (pigmentation or dry)

If we can be of assistance to you or someone you know with Elmiron-related eye damage, you can send an email to Tom Lamb or you can call us on our toll-free number: 800-426-9535. Or, if you prefer, simply submit an online Elmiron Case Evaluation Form -- it is free, confidential, and there is no obligation.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review is done by attorney Tom Lamb)

Xeljanz Has A New Drug Safety Issue, We Just Don't Know How Significant It Is, Yet

February 2021 FDA Warning: Xeljanz Increased Risks for Serious Heart-related Problems and Cancers 

 

(Posted by Tom Lamb at Drug Injury Watch)

 

During the past few years, there have been some Xeljanz drug safety alerts issued by the FDA based on a post-marketing safety clinical trial ordered by the FDA when it first approved Xeljanz (tofacitinib) in 2012. That clinical trial often goes by its short name, ORAL Surveillance, instead of its full title, "Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis".

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":

[D]espite this trial wrapping in July 2020, its full results, beyond the co-primary endpoints — including secondary endpoints such as pulmonary embolism and mortality as well as efficacy data — remain unavailable. Only the topline results have been released, and only through alerts and press releases from the FDA and Pfizer.

This has left many experts anxious to dig into the full data, which could hold drastic consequences not only for Xeljanz, but also for [Janus kinase (JAK) inhibitors] as a class. Until then, they said, it’s difficult to forecast what impact these results will have.

In our recent post, "Xeljanz FDA Drug Safety Communication in February 2021 Puts Heightened Scrutiny on Pfizer", we touched upon the two latest Xeljanz safety issues, Xeljanz causing heart problems and Xeljanz causing cancer. But there is still a lot that we do not know, yet, about how significant this new drug safety issue, or will be, for Xeljanz -- and Pfizer, the pharmaceutical company responsible for Xeljanz.

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The February 2021 Healio Rheumatology article referenced above helps us a bit on that front:

Pfizer, via a press release, announced the co-primary endpoint results of the completed study in January. Those endpoints — noninferiority with [Xeljanz (tofacitinib)] compared with TNF inhibitors related to major adverse cardiovascular events and malignancies excluding non-melanoma skin cancer — were not met, the company said. In addition, based on the prespecified secondary comparisons, there was no evidence of a difference in the primary endpoints between the two [Xeljanz (tofacitinib)] treatment groups.

According to the Pfizer release, the primary analyses included 135 participants with major adverse cardiovascular events and 164 subjects with malignancies. For [Xeljanz (tofacitinib)], the most frequently reported cardiac event was myocardial infarction, while the most frequently reported malignancy was lung cancer.

This article goes on to point out that despite the lack of data from this Xeljanz safety trial completed in July 2020, the results which have been available to date are concerning for rheumatologists:

[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.

Lastly, 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.

Besides Xeljanz, there are two other JAK inhibitors approved by the FDA:

1. Olumiant (baricitinib) from Eli Lilly & Co.; and,
2. Rinvoq (upadacitinib) from AbbVie.

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 related developments concerning Olumiant and Rinvoq.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review is done by attorney Tom Lamb)

Xeljanz FDA Drug Safety Communication in February 2021 Puts Heightened Scrutiny on Pfizer

Apparently, the Xeljanz Black Box Warning Added in July 2019 Was Not Enough; Is a Xeljanz Recall Coming Next?

 

(Posted by Tom Lamb at Drug Injury Watch)

 

In early February 2021 the FDA doubled-down on these two Xeljanz safety issues: (1) Xeljanz causing heart problems; and (2) Xeljanz causing cancer. 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)", provided the latest details about these "not-new" Xeljanz safety issues. And what I mean by this characterization is there was already a so-called Black Box Warning that points out reports of Xeljanz causing heart problems and Xeljanz causing cancer which was added to the Xeljanz drug label back in July 2019.

As background, Xeljanz (tofacitinib) is approved by the FDA for the treatment of adult patients with moderately to severely active ulcerative colitis (UC). 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.

During the past two years we have posted these earlier articles about various Xeljanz safety issues:

• February 21, 2019: "Xeljanz Recommended Dosage For Ulcerative Colitis Patients May Increase Risk Of Pulmonary Embolism"
• June 4, 2019: "Xeljanz Related Blood Clots Can Cause Pulmonary Embolism (PE) Or Deep Vein Thrombosis (DVT) With Patient Deaths Possible"
• August 1, 2019: "Xeljanz Warning For Increased Risk Of Blood Clots And Death With Higher Dose Used For Ulcerative Colitis"
• November 4, 2019: "European Medicines Agency (EMA) Warns Xeljanz Increases Risk Of Pulmonary Embolism (PE) And Deep Vein Thrombosis (DVT)"
• March 20, 2020: "Xeljanz Side Effects Include Serious, Potentially Fatal Infections As Well As Blood Clots And Venous Thromboembolism"

Coming back to the present time, let's start by taking a look at  what the FDA said at the beginning of its February 2021 Xeljanz Drug Safety Communication:

The U.S. Food and Drug Administration (FDA) is alerting the public that preliminary results from a safety clinical trial show an increased risk of serious heart-related problems and cancer with the arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib) compared to another type of medicine called tumor necrosis factor (TNF) inhibitors. FDA required the safety trial, which also investigated other potential risks including blood clots in the lungs and death. Those final results are not yet available.

We will evaluate the clinical trial results we have received to date and will work with the drug manufacturer to obtain further information as soon as possible. We will communicate our final conclusions and recommendations when we have completed our review or have more information to share.

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For what the FDA did not say -- but what can be discerned given this latest Xeljanz FDA action -- we turn to this February 4, 2021 MedPage Today news report, "No Xeljanz Plan Yet From FDA":

But the FDA is not yet prepared to take action, which could include ordering new label language, requiring a risk evaluation and mitigation strategy (REMS), or even pulling the drug from the market.

It seems highly unusual that the FDA felt compelled to point out, again, in 2021 the Xeljanz safety issues of Xeljanz causing heart problems and Xeljanz causing cancer, as those were already "highlighted" by means of the Xeljanz Black Box Warning added back in 2019.

For the time being, at least, it appears that Pfizer is not inclined to withdraw Xeljanz from the market given that there was a Xeljanz television advertisement that ran here during the national nightly news just a couple of days ago.

One wonders how the FDA might react to this continued "direct to consumer" advertising for Xeljanz which Pfizer is (still) sponsoring after the February 2021 FDA Xeljanz Drug Safety Communication about Xeljanz causing heart problems and Xeljanz causing cancer.

It seems within the realm of possibility that the FDA may mandate a Xeljanz recall in the future, but this remains to be seen.

Of course, we will be vigilant as, with the FDA, we wait for "further information" from the safety clinical trial showing an increased risk of serious heart-related problems and cancer associated with Xeljanz.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review is done by attorney Tom Lamb)