Drug Injury Watch

Beovu Lawsuits Filed Against Novartis for Patients Who Have Suffered Vision Loss Side Effects

Beovu Legal Cases Involve Retinal Artery Occlusion, Retinal Vasculitis, Intraocular Inflammation, Other Eye Problems

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

Beovu (brolucizumab) is prescribed for the treatment of neovascular (wet) age-related macular degeneration (AMD). Since being approved by the FDA in late 2019, Beovu has been associated with vision loss and blindness due to occlusive retinal vasculitis, retinal artery occlusion, intraocular inflammation, and other serious eye problems. In turn, Beovu lawsuits will likely be filed against Novartis, the manufacturer of Beovu, alleging this drug company failed to warn doctors about those serious Beovu side effects. Such drug injury Beovu legal cases might involve one or more of the following Beovu eye-related side effects:

Vision Loss
Blindness
Occlusive Retinal Vasculitis
Retinal Vasculitis
Retinal Artery Occlusion
Intraocular Inflammation
Eye Inflammation
Endophthalmitis
Retinal Detachment
Uveitis

These Beovu side effects can develop soon after the very first Beovu injection a patient receives or following a few Beovu injections, according to medical case reports submitted to the FDA.

We have created a Beovu timeline which indicates why Beovu lawsuits could be filed against Novartis.  The points of interest included in this Beovu timeline are the discovery of Beovu side effects that can lead to vision loss and blindness. statements by Novartis about Beovu drug safety issues, and more. Our Beovu timeline is kept up to date as we learn more about this Beovu drug injury situation.

You can get a quick overview of Beovu lawsuits for vision loss, blindness, and other serious eye problems on the Beovu information page for our Drug Injury Law website.

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If you want more in-depth information about the Beovu side effects situation, here are links to our earlier Drug Injury Watch articles:

• A Closer Look at the Vision-Related Side Effects Warnings Added with June 2020 Beovu Label Change (October 6, 2020)
• Safety of Beovu: A Lingering Issue Which Novartis Attempts to Counter with Recent Study Results (September 22, 2020)
• Beovu Retinal Vasculitis Case Report Is Presented In August 2020 Medical Journal Article (August 7, 2020)
• Possible Beovu Side Effects Discussed At American Society of Retina Specialists Annual Meeting In July 2020 (July 28, 2020)
• Beovu Safety Signal Found By External Review Committee Which Evaluated Beovu Post-Marketing Adverse Events (July 1, 2020)
• Beovu Label Change: Warnings About Possible Permanent Vision-Loss Side Effects Added In June 2020 (June 17, 2020)
• Beovu Vision-Related Side Effects Warnings Label Change Request By Novartis: News Report (April 9, 2020)
• Novartis Contends Beovu Safety Should Not Be In Dispute As Current Drug Label Provides Sufficient Warnings (March 4, 2020)
• Beovu Side Effects Include Retinal Vasculitis, Eye Inflammation: Safety Issues For Macular Degeneration Drug (February 27, 2020)

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 these drug injury Beovu legal cases. Or you can call us on our toll-free number: 800-426-9535.

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

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Picato Recalls Continue with Canada and Denmark Being Most Recent, All Due to Risk of Skin Cancer

A Global Phase-out of Picato Sales by LEO Pharma Inc. Due to this Picato Safety Finding Expected by End of 2020

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

 

But first, we get more information about this latest Picato recall from the above-referenced document:

Health Canada conducted a safety review of PICATO and concluded that there may be a link between its use and an increased risk of non-melanoma skin cancer. On July 2, 2020, Health Canada informed Canadians of this risk. In light of the risk of cancer, Health Canada further assessed the benefit-risk profile of PICATO and determined that the benefits of treatment with PICATO do not outweigh the potential risk of skin cancer.

On October 14, 2020, Health Canada directed LEO Pharma Inc. to stop the sale of PICATO at the manufacturer level. Subsequently, on October 26, 2020, LEO Pharma Inc. initiated the recall of PICATO from the Canadian market.

Here is the July 2020 Picato safety alert issued by Health Canada previously: "Summary Safety Review - Picato (ingenol mebutate) - Assessing the Potential Risk of Skin Cancer".

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Before this Picato recall in Canada, there had been several earlier Picato product withdrawals due to an increased risk of skin cancer as a Picato side effect. As reported in this October 28, 2020 item, "Denmark’s LEO Pharma initiates Picato phase-out", published on thepharmaletter.com site:

Following safety warnings on Picato (ingenol mebutate) from regulators, including the European Medicines Agency and the US Food and Drug Administration, Danish drugmaker LEO Pharma yesterday announced it was initiating a phase-out for the product, a gel for the treatment of actinic keratosis, which is expected to be completed by year-end 2020 at the latest as follows:

In the USA, LEO Pharma provided the FDA with notification of the permanent discontinuation in the manufacture of Picato and the withdrawal of New Drug Application (NDA) 202833 as Picato will no longer be marketed.

In Australia, LEO Pharma has already informed wholesalers and prescribers about discontinuation of Picato and will be withdrawing the marketing authorization.

We will continue to monitor significant developments as regards the Picato safety finding of an increased risk of skin cancer as well as watch for ramifications of the 2020 global Picato recall.

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

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Drug Safety Issue for Stelara: Severe Cardiovascular Events Soon After Initiation of Stelara Treatment

Stelara-Associated Acute Coronary Syndrome, Stroke, and Unstable Angina Seen in Recent Stelara French Medical Study

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

Stelara (ustekinumab) was approved by the FDA in 2009, initially for Crohn's disease and psoriatic arthritis, then ulcerative colitis in October 2019 and psoriasis in July 2020. Now, despite these recent additional treatment indications, there is an emerging drug safety issue for Stelara. In particular, Stelara-associated cardiovascular events were reported in a French medical study which, in turn, has resulted in some concern about the safety of Stelara.

The Stelara French study results were outlined in this medical journal article, "Association Between Early Severe Cardiovascular Events and the Initiation of Treatment With the Anti–Interleukin 12/23p40 Antibody Ustekinumab", published online September 9, 2020, by JAMA Dermatology. From the Abstract from this article:

Objective:  To assess whether the initiation of [Stelara (ustekinumab)] treatment is associated with increased risk of [severe cardiovascular events (SCEs)].

Design, Setting, and Participants:  This case-time-control study used data from the French national health insurance database, covering 66 million individuals, on all patients exposed to [Stelara (ustekinumab)] between April 1, 2010, and December 31, 2016, classified according to their cardiovascular risk level (high- and low-risk strata). The risk period was the 6 months before the SCE, defined as acute coronary syndrome or stroke, and the reference period was the 6 months before the risk period....

Results:  Of the 9290 patients exposed to [Stelara (ustekinumab)] (4847 men [52%]; mean [SD] age, 43 [14] years), 179 experienced SCEs (65 cases of acute coronary syndrome, 68 cases of unstable angina, and 46 cases of stroke). Among patients with a high cardiovascular risk, a statistically significant association between initiation of [Stelara (ustekinumab)] treatment and SCE occurrence was identified (odds ratio, 4.17; 95% CI, 1.19-14.59). Conversely, no statistically significant association was found among patients with a low cardiovascular risk (odds ratio, 0.30; 95% CI, 0.03-3.13).

Conclusions and Relevance:  This study suggests that the initiation of [Stelara (ustekinumab)] treatment may trigger SCEs among patients at high cardiovascular risk.... Although the study interpretation is limited by its observational design, these results suggest that caution may be needed in the prescription of [Stelara (ustekinumab)] to patients at high cardiovascular risk.

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Some commentary about this emerging drug safety issue for Stelara can be found in a September 18, 2020, Medscape article, "Study Results Suggest Ustekinumab May Trigger Acute CV Events Early in Treatment":

Offering a U.S. clinician's perspective on the French study, Anthony Fernandez, MD, PhD, director of medical dermatology at the Cleveland Clinic, called the findings "unique and interesting with very robust odds ratios. These posttreatment associations have actually been a big area of research over the past decade but not with such defined time periods."

No significant increases in risk have been seen with other biologics, Dr. Fernandez added, with the exception of briakinumab [(a human monoclonal antibody which is not FDA-approved)]. "But still, the current study does not definitively answer the question whether [Stelara (ustekinumab)] can trigger acute events within 6 months of treatment. There's smoke, but we haven't clearly seen a fire."...

... "The data certainly support the need for further research in this area," he said in an interview, "and in the meantime this paper will probably make me extra cautious in using [Stelara (ustekinumab)] in those at significant risk."

We point out that other medical experts who commented about this French medical study showing Stelara-associated cardiovascular events for the Medscape article were skeptical about the study's findings and less concerned as regards the safety of Stelara.

Of course, we will continue to monitor this emerging drug safety issue for Stelara, watching for further medical research about Stelara-associated cardiovascular events and any regulatory actions related to the safety of Stelara.

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

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Ocaliva FDA Adverse Events Reports for Hepatobiliary System Cases: An Analysis as of October 2020

Lack of Warnings in Current Ocaliva Drug Label for Some Serious Side Effects Involving Liver, Gallbladder, Bile Ducts

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

We are still wondering how the current FDA investigation of an Ocaliva safety signal -- said to be involving a potential liver disorder risk -- was able to fly below the radar for five months before first being reported in early October 2020. Remarkably, the first mention of this possible Ocaliva liver toxicity issue was found in a U.S. Securities and Exchange Commission (SEC) financial quarterly report filed by Intercept Pharmaceuticals, as discussed in our last article, "Potential Ocaliva - Liver Disorder Safety Signal Being Investigated by FDA as Side Effects Risk".

A few days after that FDA Ocaliva investigation "discovery" was made, we were provided some additional information about what types of hepatobiliary events (i.e., involving liver, gallbladder, bile ducts, or bile) might have given rise to this Ocaliva safety signal. From an October 13, 2020 news report, "Shedding light on Intercept’s opaque disclosure", published by Evaluate Vantage, we get these details:

[The safety database Advera Health Analytics] which gets its data from the FDA’s FAERS adverse event reporting system and adjusts for a number of factors to add context and remove duplication, shows several active liver toxicity signals not already cited on Ocaliva’s label.

These include liver failure and portal hypertension, all derived from adverse event reporting from in-market use of Ocaliva for [treatment of a rare chronic liver disease, primary biliary cholangitis (PBC)]....

One caveat is that all of these issues could be related to the underlying disease, since PBC affects the liver, but the higher the [risk odds ratio (ROR)] the less likely it seems that this would explain away the adverse event seen.

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For more details, we point out the Table titled "Most frequently reported adverse events for Ocaliva in the hepatobiliary system organ class" which is part of this recent Evaluate Vantage news report about the Ocaliva safety signal FDA investigation. Taken from that Table, here is a list of "serious" adverse events which were reported to the FDA but that are not "cited" on the current Ocaliva drug label:

• Chronic hepatic failure
• Portal hypertension
• Hepatic failure
• Hepatorenal syndrome
• Autoimmune hepatitis

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.

Of course, while we watch for findings from the FDA Ocaliva safety signal investigation, we will continue to monitor the medical and regulatory realms for significant developments regarding this Ocaliva liver toxicity issue.

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

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Potential Ocaliva - Liver Disorder Safety Signal Being Investigated by FDA as Side Effects Risk

October 2020 News Report Reveals "New" Ocaliva Liver Safety Issue, Which Had Been Under the Radar Previously

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

Ocaliva (obeticholic acid) was approved by the FDA in 2016 for the treatment of a rare chronic liver disease, primary biliary cholangitis (PBC). Specifically, Ocaliva is FDA-approved for use in combination with ursodeoxycholic acid (UDCA) in adult PBC patients with an inadequate response to UDCA, or as monotherapy in adult PBC patients unable to tolerate UDCA.

Back in 2017 and 2018, the FDA warned that Ocaliva was being incorrectly dosed daily instead of weekly in patients with PBC, and thereby increasing the risk of serious liver injury. For the details of this earlier drug safety issue for Ocaliva, see "FDA adds Boxed Warning to highlight correct dosing of Ocaliva (obeticholic acid) for patients with a rare chronic liver disease".

In October 2020 we first learned about a "new" drug safety issue for Ocaliva -- although it apparently has been on the FDA's radar since at least May 2020. Again, a possible Ocaliva liver-related side effects risk is what has attracted FDA scrutiny.

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It was this October 9, 2020, Endpoints News article, "In another blow to Intercept, the FDA is investigating Ocaliva for potential risk of liver disorder", which brought to light an Ocaliva liver safety FDA evaluation. In relevant part:

Just a month before handing Intercept Pharmaceuticals a CRL for Ocaliva in NASH, the FDA began evaluating the drug for a potential risk of liver disorder in primary biliary cholangitis (PBC) patients. The probe, which launched in May, was disclosed by the company deep down in their latest quarterly report filed with the SEC, and had not otherwise been communicated publicly by Intercept until reports surfaced this week.

[From that Intercept quarterly report: "The FDA has notified us that in the course of its routine safety surveillance, in May 2020 the FDA began to evaluate a newly identified safety signal regarding liver disorder for Ocaliva which the FDA classified as a potential risk...."]

An FDA spokesperson declined to offer any additional information aside from what was posted in FAERS, the agency’s adverse event reporting system, which states they are “evaluating the need for regulatory action.”

It was further reported in this October 2020 Endpoints News article that a spokesman for Intercept, the pharmaceutical company responsible for Ocaliva, said he anticipates the current Ocaliva liver safety FDA evaluation would take about 12 months.

As such, given that this Ocaliva liver safety FDA evaluation began about five months ago, we can look for the ongoing FDA investigation of possible Ocaliva liver disorder side effects to conclude in or about May 2021. Of course, between now and then we will be on the look-out for any significant developments concerning this new / not-so-new drug safety issue for Ocaliva.

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

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A Closer Look at the Vision-Related Side Effects Warnings Added with June 2020 Beovu Label Change

New Beovu Warnings for Endophthalmitis and Retinal Detachment as well as Retinal Vasculitis, Retinal Vascular Occlusion

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

In June 2020 Novartis revised the Prescribing Information for Beovu to add new warnings for some vision-related side effects linked to Beovu. In this earlier article, "Beovu Label Change: Warnings About Possible Permanent Vision-Loss Side Effects Added In June 2020", about that Beovu label change we focused on the new warnings about Beovu-associated retinal vasculitis and/or retinal vascular occlusion. Now, as regards the Beovu eye drug safety issue of vision loss, we look at the Beovu-associated endophthalmitis and Beovu-associated retinal detachment side effects.

From the new Beovu drug label, or "Full Prescribing Information (Revised: 6/2020)" document, in the WARNINGS AND PRECAUTIONS, here is the Beovu-associated endophthalmitis and Beovu-associated retinal detachment side effects warning:

5.1 Endophthalmitis and Retinal Detachment

Intravitreal injections, including those with BEOVU, have been associated with endophthalmitis and retinal detachment [see Contraindications (4.1) and Adverse Reactions (6.1)]. Proper aseptic injection techniques must always be used when administering BEOVU. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately [see Dosage and Administration (2.4) and Patient Counseling Information (17)].

As the retinal detachment is a more easily understood medical condition, we will take a closer look at the Beovu-associated endophthalmitis side effect part of the Beovu eye drug safety issue of vision loss in this article.

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To start, here is the definition of endophthalmitis from EyeWiki, a service of the American Academy of Ophthalmology.

Endophthalmitis is a purulent inflammation of the intraocular fluids (vitreous and aqueous) usually due to infection.

• Serious intraocular inflammatory disorder resulting from infection of the vitreous cavity
• Progressive vitritis is the hallmark of any form of endophthalmitis
• Histologically: massive infiltration of the vitreous cavity with inflammatory cells

For some information about Beovu-associated endophthalmitis we turn to an article published in August 2020 by the American Journal of Ophthalmology, ominously titled "Is This a 737 Max Moment for Brolucizumab?":

[S]oon after the widespread community adoption of [Beovu (brolucizumab)], sporadic reports began to surface that patients were experiencing severe sterile inflammation that could be difficult to distinguish from infectious endophthalmitis. Although cases of severe sterile noninfectious intraocular inflammation have been reported following the injection of other anti-VEGF drugs, this [Beovu (brolucizumab)]-associated inflammation was unusual because it was associated with an occlusive vasculitis and irreversible severe vision loss, albeit rare. This unpredictable severe inflammation could develop weeks after the last [Beovu (brolucizumab)] injection even if previous injections of [Beovu (brolucizumab)] were well tolerated, so previous [Beovu (brolucizumab)] injections without inflammation were no guarantee that subsequent injections would be safe.

The retinal community had not reported this type of vision-threatening occlusive retinal vasculitis after intravitreal injections of other commonly used anti-VEGF drugs, such as aflibercept, bevacizumab (Avastin; Genentech, South San Francisco, California, USA), and ranibizumab (Lucentis; Genentech).... [Footnotes omitted.]

We are currently investigating drug injury lawsuits against Novartis for Beovu causing vision loss and blindness which involve Beovu-associated endophthalmitis. This is in addition to Beovu cases which involve these more well-known vision-related Beovu side effects: occlusive retinal vasculitis; retinal artery occlusion; and, intraocular inflammation.

And, of course, we continue to watch for any information released by Novartis about the findings of their panel of experts who are considering this Beovu eye drug safety issue of vision loss.

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

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