Side Effects Blog

From the Summary section of that 2021 Federal Register Notice:

The Food and Drug Administration (FDA or Agency) has determined that BELVIQ (lorcaserin hydrochloride) tablets, 10 milligrams (mg), and BELVIQ XR (lorcaserin hydrochloride) extended-release tablets, 20 mg, were withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications (ANDAs) for lorcaserin hydrochloride tablets, 10 mg and 20 mg.

According to that 2021 Federal Register Notice, this further FDA action regarding Belviq means:

[The FDA] will remove BELVIQ (lorcaserin hydrochloride) tablets, 10 mg, and BELVIQ XR (lorcaserin hydrochloride) extended-release tablets, 20 mg, from the list of drug products published in the Orange Book. FDA will not accept or approve ANDAs that refer to this drug product.

Going back to the February 2020 FDA Drug Safety Communication announcing the Belviq drug recall, “FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market”, these are some of the specific types of cancer associated with Belviq:

Pancreatic Cancer
Colorectal Cancer
Colon Cancer
Rectal Cancer
Lung Cancer

Our law firm is investigating possible Belviq lawsuits where patients have been diagnosed with cancer, including but not limited to the types listed above.

One indication of this concern is found in a March 18, 2021, BioPharma news report, “AbbVie’s approval delay raises further concerns about JAK drugs”, from which we get the following:

The Food and Drug Administration may take up to three months longer to review an application from AbbVie to get Rinvoq, its marketed medicine for rheumatoid arthritis, also approved to treat active psoriatic arthritis. The company now expects a decision toward the end of the second quarter.

AbbVie gave few details about the reasons for the delay in a Wednesday statement, noting only that the FDA had requested new information on the drug’s benefits and risks in psoriatic arthritis patients. But after speaking with the company, Vamil Divan, an analyst at Mizuho Securities, learned the requests were for long-term safety data similar to what Pfizer recently showed for Xeljanz, a rival drug that works like Rinvoq.

We will continue to watch for newly released information from the Xeljanz safety clinical trial that showed Xeljanz-associated heart problems and possible Xeljanz-related cancers and which is the basis for the February 2021 Xeljanz FDA Drug Safety Communication. In addition, for the reasons stated above, we will monitor the safety profile of Rinvoq and Olumiant to see whether those are JAK inhibitors drug class adverse drug events and side effects risks.

As regards the pigmentary maculopathy Elmiron side effect, the new Elmiron Medication Guide includes the following:

Changes in the retina of the eye (pigmentary maculopathy). Taking ELMIRON may be associated with pigment changes in the retina of the eye that may continue even after stopping treatment with ELMIRON. Tell your healthcare provider including your eye doctor right away if you have any vision changes including any of these symptoms:

• difficulty reading
• your vision takes longer to adjust to low or reduced light
• blurred vision

Throughout your treatment, regular eye examinations that include retinal examinations are suggested for early detection of retinal/macular changes….

As we have stated previously, the June 2020 Elmiron label change that finally added warnings concerning vision problems such as retinal pigmentary changes and pigmentary maculopathy was overdue from our perspective. Accordingly, there have been Elmiron lawsuits filed by patients who have suffered vision loss against the pharmaceutical companies responsible for Elmiron.

We are currently investigating possible Elmiron lawsuits for patients with past Elmiron use diagnosed with retinal pigmentary eye problems such as the pigmentary maculopathy Elmiron side effect.

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.

(1) We started investigating these Beovu eye problems soon after the American Society of Retinal Specialists (ASRS) issued a Beovu drug safety alert to its members in February 2020. In fact, our February 27, 2020 article, “Beovu Side Effects Include Retinal Vasculitis, Eye Inflammation: Safety Issues For Macular Degeneration Drug“, was one of the first articles written about these Beovu eye problems.

(2) During the past 13 months — from February 2020 to March 2021 — we have closely monitored this Beovu drug safety issue and written many more articles about the circumstances surrounding various Beovu eye injection reactions causing vision loss and blindness such as:

• Retinal Vasculitis
• Occlusive Retinal Vasculitis
• Retinal Artery Occlusion
• Retinal Vascular Occlusion

(3) The first three Beovu vision loss lawsuits filed in the US were for clients of our law firm. Each of those three women had their Beovu lawsuit filed as an individual case. The basic liability allegations in those Beovu lawsuits, as well as other Beovu cases concerning Beovu eye problems, are:

• Novartis misrepresented that Beovu was a safe treatment for age-related macular degeneration; and,
• Novartis failed to warn about Beovu eye injection reactions causing vision loss and blindness.

If we can be of assistance to you or someone else regarding a possible Beovu lawsuit for vision loss or blindness due to Beovu eye injection reactions, you can submit a Beovu Case Evaluation Form online or you can call us on our toll-free number: 800-426-9535.

Again, we point out the important fact that these Beovu vision loss lawsuits are filed as individual cases. There will not be any Beovu class actions for Beovu eye problems. As such, people with Beovu eye injection reactions must contact a lawyer or law firm to have their Beovu lawsuit filed so they can get legal compensation from Novartis for their Beovu drug injury.

We respectfully suggest those people should contact our law firm for the 3 reasons set forth above.

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.