Side Effects Blog

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.

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.

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.

Information for consumers and health professionals on new drug warnings and other safety information, drug label changes, and shortages of medically necessary drug products.

FDA Adverse Event Reporting System (FAERS) from the U.S. Food and Drug Administration

FDA Adverse Event Reporting System supports the FDA’s post-marketing safety surveillance program for all marketed drug and therapeutic biologic products. It contains adverse event reports FDA has received from manufacturers as required by regulation along with reports received directly from consumers and healthcare professionals.

And here’s one more research resource, this one from the National Library of Medicine, for finding drug safety and side effects warnings information:

DailyMed from the U.S. National Library of Medicine

The National Library of Medicine (NLM)’s DailyMed searchable database provides the most recent labeling submitted to the Food and Drug Administration (FDA) by companies and currently in use (i.e., “in use” labeling). DailyMed contains labeling for prescription and nonprescription drugs for human and animal use, and for additional products such as medical gases, devices, cosmetics, dietary supplements, and medical foods.

At the Law Offices of Thomas J. Lamb, we are constantly monitoring drug safety and side effects warnings information because we represent people in drug injury cases.

If we can assist you or someone you know with a possible drug injury case, you can submit an online Case Evaluation Form or you can call us on our toll-free number: 800-426-9535.

Here is a list of the drug injury cases that our law firm is involved with at the present time.

• 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.

In June 2021 it was reported that Invokana, Farxiga, Jardiance, and other drugs in the Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors class, are associated with an increased risk of retinal vein occlusion. This new SGLT2 inhibitors side effect was the subject of a presentation at the 81st Scientific Sessions of the American Diabetes Association which was based on the first study to examine the potential association of retinal vein occlusion with the use of SGLT2 inhibitors.

From this news report published on the PracticeUpdate website (free registration required), “ADA 2021: SGLT2 Inhibitors May Increase the Risk of Retinal Vein Occlusion”, we get these details:

In a subgroup analysis, significant interactions were evident with use SGLT2 inhibitors and risk of retinal vein occlusion concerning age ≥ 60 years (hazard ratio 1.53, 95% confidence interval 1.20–1.94, P =.0135) and estimated glomerular filtration rate < 60 mL/min/1.73 m2 (hazard ratio 3.13, 95% confidence interval 155–6.32, P = .0083). No significant interactions were evident for sex, age, body mass index, presence of comorbidities, multiple lifestyle factors, or use of other anti-diabetes agents.

[The researchers concluded] “In a matched cohort study, we found that SGLT2 inhibitors were associated with a significantly increased risk of retinal vein occlusion. The elderly and patients with chronic kidney disease were at higher risk for retinal vein occlusion,”….

Of course, we will continue to monitor the medical literature for more about this new SGLT2 inhibitors side effect related to vision/eyes, retinal vein occlusion.

In postponing Rinvoq, the FDA said it’s still reviewing those Pfizer data, according to AbbVie. In February, the agency alerted patients and doctors of Xeljanz’s safety signal. At that time, it said it would dig into the results and consider what moves to take.

Existing JAK inhibitors, including Rinvoq, already bear warnings of increased risk of blood clots on their U.S. labels. Xeljanz’s cardiovascular red flag obviously made the FDA nervous about it being a class-wide problem for all JAK drugs.

For some additional perspective, we turn to this June 25, 2021, EndpointNews article, “FDA pushes back decisions on AbbVie’s Rinvoq sNDAs to further review a failed Pfizer trial”:

The regulator’s continued evaluation of the Pfizer trial shows those safety concerns have not abated. Pfizer announced in January that ORAL Surveillance, its six-year post-marketing trial for its JAK inhibitor Xeljanz, had failed. Across 4,362 patients, those who received either a low or high dose of Xeljanz experienced more major cardiovascular events — such as stroke and heart attack — than those on Humira or Enbrel. They also had higher rates of cancer, with Pfizer failing to hit non-inferiority on both primary endpoints.

We will continue to watch for further developments and indications concerning an FDA Advisory Committee for Xeljanz, Rinvoq, and other JAK inhibitors so that outside experts to review their risk/benefit profiles as regards new indications such as atopic dermatitis. If this comes to be, we expect that FDA Advisory Committee would be discussing the new JAK inhibitors heart side effects and cancer risks issues which were flagged by means of the earlier Xeljanz safety signal.

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. In turn, strokes, heart attacks, and lower limbs amputations can be Tasigna side effects as these are serious medical conditions that can result from, or are secondary to, atherosclerosis-related diseases.

In more detail, 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.

As background, in Canada the drug company Novartis Pharmaceuticals has issued stronger warnings about atherosclerosis-related diseases being Tasigna side effects — compared to what is found on the US version of the Tasigna drug label. This situation has given rise to the contention that warnings about Tasigna side effects in the current US drug label are insufficient, or a failure to adequately warn. In turn, Tasigna drug injury lawsuits have been filed against Novartis here in the U.S.

Novartis has proactively communicated these data to health authorities and will pursue an update to the Beovu prescribing information globally.

We are watching for this forecasted Beovu label change which will, presumably, add new and updated warnings about Beovu vision loss side effects.

For a more in-depth view of this latest development as regards Beovu safety issues, we turn to this June 1, 2021, FiercePharma news report, “Novartis calls off 3 Beovu trials testing more frequent dosing on concerns of vision-threatening side effect”:

[In the MERLIN clinical trial] Beovu doubled the rate of intraocular inflammation compared with [Eylea], with 9.3% percent of patients suffering the complication in the Beovu trial arm. That compared with 4.5% for Eylea. None of the Eylea patients developed reginal vasculitis or retinal vascular occlusion, while those side effects happened in 0.8% and 2% of Beovu patients, respectively. The problem could potentially damage a person’s vision.In Merlin, the rate of vision loss from any cause was 4.8% for Beovu patients and 1.7% for Eylea patients….

The company has yet to identify the root cause behind Beovu’s safety problem.

As we have reported previously, Beovu lawsuits for our clients have been filed starting in January 2021, alleging Novartis failed to warn doctors and patients about these Beovu safety issues. Our law firm began investigating drug injury lawsuits against Novartis for Beovu back in February 2020, and we continue to accept Beovu cases that involve vision loss and blindness due to occlusive retinal vasculitis, retinal artery occlusion, and intraocular inflammation.

From the May 2021 Ocaliva FDA Drug Safety Communication we get this statement about what the FDA is doing:

We added a new Contraindication, FDA’s strongest warning, to the Ocaliva prescribing information and patient Medication Guide stating that Ocaliva should not be used in PBC patients with advanced cirrhosis. Advanced cirrhosis is defined as cirrhosis with current or prior evidence of liver decompensation (e.g., encephalopathy, coagulopathy) or portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia). We also revised the Boxed Warning, our most prominent warning, to include this information along with related warnings about this risk.

And later in the May 2021 Ocaliva FDA Drug Safety Communication about a “new” Ocaliva-related liver injury and the Ocaliva label change, here is what the FDA found during its Ocaliva liver safety evaluation:

In the five years since Ocaliva’s accelerated approval, FDA identified 25 cases of serious liver injury leading to liver decompensation or liver failure associated with Ocaliva in PBC patients with cirrhosis, both in those without clinical signs of cirrhosis (compensated) or in those with clinical signs of cirrhosis (decompensated). Many of these PBC patients had advanced cirrhosis before starting Ocaliva…. After starting Ocaliva, the pace of the liver decompensation or failure reported suggested these adverse events, which resulted in liver transplant in a small number of cases, were related to the drug rather than progression of the underlying PBC.

We are investigating possible Ocaliva drug injury lawsuits that would be filed against Intercept Pharmaceuticals, the responsible drug company, for patients who have been diagnosed with these serious possible Ocaliva side effects.

Purpose of review: The aim of the present review is to provide a comprehensive summary of available knowledge regarding toxic maculopathy secondary to [Elmiron, or pentosan polysulfate sodium (PPS)].

Recent findings: [Elmiron (PPS) toxicity] was described in 2018, and additional studies characterize it as dysfunction of the retinal pigment epithelium centered on the posterior pole, which can progress despite drug cessation. Requisite exposure can be as little as 0.325 kg and 2.25 years but averages closer to 1–2 kg and 10–15 years. Multimodal imaging should include near-infrared reflectance, optical coherence tomography, and fundus autofluorescence. Cross-sectional studies demonstrate evidence correlating cumulative dosing and the likelihood/severity of maculopathy. Early estimates of prevalence range from 12.7 to 41.7% depending on dosing, with overall rates around 20%.

It is important to know that a patient does not need to have current Elmiron use right up until the time when their pigmentary maculopathy is diagnosed for it to be considered Elmiron-related eye damage.

We are currently investigating possible Elmiron lawsuits for patients with past Elmiron use diagnosed with pigmentary maculopathy. If we can assist you with an Elmiron-related eye damage legal case, you can submit an online Elmiron Case Evaluation Form or call us on our toll-free number: 800-426-9535.