Side Effects Blog

The 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 we get these facts about high levels of Elmiron use:

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.

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

We are currently investigating possible Elmiron lawsuits for patients with past Elmiron use diagnosed with pigmentary maculopathy or macular degeneration.

If we can be of assistance to you or someone you know with Elmiron-related eye damage, you can submit an online Elmiron Case Evaluation Form or you can call us on our toll-free number: 800-426-9535.

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.

As to what the FDA did not say in that 2021 Xeljanz FDA Drug Safety Communication — but what seems to be indicated by this latest Xeljanz FDA action — we refer you 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.

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 in my part of the country during the national nightly news a couple of days after this “new” 2021 FDA drug safety alert about Xeljanz side effects was issued.

One wonders how the FDA might react to this “direct to consumer” advertisement for Xeljanz which Pfizer was still running 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.

• Like Eylea and Lucentis, Beovu injections are used for the treatment of neovascular (wet) age-related macular degeneration (AMD).
• However, Beovu side effects such as occlusive retinal vasculitis, retinal artery occlusion, and intraocular inflammation have resulted in vision loss and blindness.
• Starting in January 2021 Beovu lawsuits have been filed for patients alleging Novartis failed to adequately warn about these serious Beovu side effects.
• Given this situation, some eye doctors are avoiding Beovu when treating their AMD patients.

A possible indication of the Novartis strategy for battling back from this less-than-ideal current posture can be found in a “Novartis Fourth Quarter and Full Year 2020 Condensed financial report – Supplementary Data” document:

Post marketing cases termed as “intraocular inflammation.” and/or “retinal vascular occlusion” that may result in severe vision loss, typically associated with intraocular inflammation and the current COVID-19 situation had an unfavorable impact on sales. Novartis has a comprehensive plan, in strong collaboration with leading external global experts to educate the retina community about the positive benefit / risk profile of Beovu.

It seems that this Novartis plan to get Beovu back on the path of being a so-called “blockbuster” drug for Novartis in terms of sales might involve its external safety review committee (SRC). In the past, Novartis has implied that this panel of experts was set up to provide an independent review of the Beovu side effects case reports.

Our law firm is investigating possible Beovu lawsuits for patients who have suffered vision loss or blindness due to Beovu side effects. If we can be of assistance to you or someone else regarding a Beovu drug injury case, you can submit a Case Evaluation Form online or you can call us on our toll-free number: 800-426-9535.

From that January 2021 medical journal article about Elmiron maculopathy we get this background information set forth in its Introduction section:

Macular toxicity secondary to pentosan polysulfate sodium (PPS) (Elmiron; Janssen Pharmaceuticals, Beerse, Belgium) was first reported in 2018. PPS is the only U.S. Food and Drug Administration (FDA)-approved oral treatment for interstitial cystitis (IC), a painful urological condition affecting approximately 45 in 100,000 women and eight in 100,000 men globally.

Another contribution of this new Elmiron medical study to the medical literature has to do, in large part, with how one might diagnose Elmiron maculopathy secondary to pentosan polysulfate (PPS) toxicity. From the Conclusions section of the January 2021 OSLI Retina article:

Patients with long-term [use of Elmiron, i.e., exposure to PPS] may present with various pre-existing diagnoses but most PPS toxicity cases manifest with a specific constellation of OCT, FAF, and [OCT angiography (OCTA)] findings. Established maculopathy patients should be questioned regarding exposure to PPS, especially with negative genetic testing or atypical presentations.

Our law firm is investigating possible Elmiron lawsuits for patients who have suffered vision loss due to Elmiron maculopathy. If we can be of assistance to you or someone else regarding an Elmiron vision loss case, you can submit an Elmiron Case Evaluation Form online or you can call us on our toll-free number: 800-426-9535.

The most recent periodic review of international safety data identified cases of liver failure, some requiring liver transplant, in patients treated with GILENYA. Other cases of clinically significant liver injury were also reported in patients treated with GILENYA. Signs of liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, have appeared shortly following the initiation of treatment as well as after prolonged use.

In the US, the Gilenya drug label was revised back in November to add warnings about Gilenya-associated liver injury, including acute liver failure requiring a liver transplant. See 5 WARNINGS AND PRECAUTIONS, 5.5 Liver Injury.

We will watch to see whether the FDA mandates any further Gilenya label change with increased liver risk warnings here in the US going forward.

After considering the argument of counsel, we find that centralization of these actions in the District of New Jersey will serve the convenience of the parties and witnesses and promote the just and efficient conduct of the litigation. The actions involve common factual issues concerning the propensity of Elmiron to cause retinal injuries, notably atypical or pigmentary maculopathy. Several defendants have marketed Elmiron since its approval in 1996. This litigation likely will implicate complex scientific and regulatory issues. Centralization will eliminate duplicative discovery; avoid inconsistent pretrial rulings; and conserve the resources of the parties, their counsel and the judiciary. [Footnote omitted.]

Unlike most pharmaceutical drug injury lawsuits, for these Elmiron legal cases a person does not need to have been using Elmiron at the time when their eye damage or retinal injury was diagnosed by a doctor. This is because there can be a delay, or latency period, from a patient’s Elimiron “exposure” until there is Elmirion “toxicity” causing eye damage and retinal injury.

If we can be of assistance to you or someone else regarding a possible Elmiron lawsuit, you can send can submit an online Elmiron Case Evaluation Form or you can call us on our toll-free number: 800-426-9535.

Two months earlier, in September 2020, stronger warnings about retinal vasculitis and/or retinal vascular occlusion were put in the Beovu drug label used in Europe. See “Safety of Beovu: A Lingering Issue Which Novartis Attempts to Counter with Recent Study Results“.

That happened three months after there was a Beovu label change here in the US. See “Beovu Label Change: Warnings About Possible Permanent Vision-Loss Side Effects Added In June 2020“.

It was back in April 2020 that Novartis said it would work with drug safety regulators around the world to issue revised Beovu drug labels with new warnings about Beovu vision-related side effects. See “Beovu Vision-Related Side Effects Warnings Label Change Request By Novartis: News Report“.

But only a month before that, in March 2020, Novartis had asserted that its original (and then current) Beovu drug labels in the US and Europe were already had sufficient warnings about the Beovu adverse drug reactions and Beovu-related eye problems associated with its (then) relatively new age-related macular degeneration (AMD) drug. See “Novartis Contends Beovu Safety Should Not Be In Dispute As Current Drug Label Provides Sufficient Warnings“.

And this Beovu “safety issue” all started in February 2020, when the American Society of Retinal Specialists (ASRS) issued an alert to members about 14 cases of retinal vasculitis associated with Beovu injections. See “Beovu Side Effects Include Retinal Vasculitis, Eye Inflammation: Safety Issues For Macular Degeneration Drug“.

So, what might happen in 2021 as regards these Beovu adverse drug reactions and Beovu-related eye problems? One thing we are anxiously waiting for is more information to be released by Novartis about the findings of their panel of experts who are considering this Beovu safety issue.

Our law firm is investigating possible Beovu lawsuits for patients who have been diagnosed with vision loss, blindness, or other serious eye problems which are Beovu side effects.  Please feel free to send an email to Tom Lamb if we can be of assistance to you or someone else regarding a Beovu drug injury case. Or you can call us on our toll-free number: 800-426-9535.

Turning to Elmiron side effects warnings developments, on December 15, 2020, a Dear Healthcare Professional Letter titled, “ELMIRON (pentosan polysulfate sodium) and the Risk of Pigmentary Maculopathy”, was issued in Canada by Janssen, Inc. and Health Canada. Its key messages were: (1) Cases of Elmiron pigmentary maculopathy have been reported with long-term use of Elmiron; and (2) Elmirion is now contraindicated in patients with a previous history of any macular pathology.

Lastly, there is some new information about Elmiron pigmentary maculopathy diagnosis methods. A December 22, 2020, medical article, “From Bladder Pain to Blurry Vision: Pentosan Polysulfate Sodium and the Development of a Novel Maculopathy”, published in Ophthalmic Surgery, Lasers and Imaging Retina, discusses the symptoms of pigmentary maculopathy as well as how doctors might diagnose this serious eye disease which may lead to significant vision loss.

Our law firm is investigating possible Elmiron lawsuits for patients who have suffered vision loss due to Elmiron pigmentary maculopathy. If we can be of assistance to you or someone else regarding an Elmiron vision loss case, you can submit an online Elmiron Case Evaluation Form or you can call us on our toll-free number: 800-426-9535.

In more detail, this woman was treated with three injections of Beovu resulting in retinal vasculitis and intraocular inflammation one week after the Beovu third injection. About one month later, her doctors administered a Lucentis treatment. Soon thereafter this patient developed severe vitritis with worsening occlusive retinal vasculitis.

When reading this Beovu case report it appears this woman’s doctors were not sure whether (1) Lucentis had a role in the retinal occlusive vasculitis, worsening intraocular inflammation, and severe vision loss she suffered soon after her Lucentis injection, or (2) this was a Beovu vision loss case due to delayed Beovu hypersensitivity.

In the Abstract for this Beovu case report, however, we find this statement at the “Conclusion and importance” part:

Treatment with [Beovu (brolucizumab)] can result in intraocular inflammation and retinal vasculitis likely due to a delayed hypersensitivity reaction to the drug, supported by cytopathologic analysis of a vitreous sample. We demonstrate a case where retreatment with an alternative anti-VEGF agent resulted in worsening vision and vasculitis.

Our law firm is investigating possible Beovu lawsuits for patients who have been diagnosed with Beovu-related retinal vasculitis and suffered vision loss or blindness. If we can be of assistance to you or someone else regarding a Beovu vision loss case, you can submit an online Beovu Case Evaluation Form or you can call us on our toll-free number: 800-426-9535.