Drug Safety Developments

Xeljanz Safety Trial Results Which May Lead to Xeljanz Recall

Other JAK Inhibitors May Be Negatively Affected by Xeljanz Study Results, Too

 

Written by: Lauren Schwab, Legal Assistant

Law Offices of Thomas J. Lamb, P.A.

 

On February 5, 2021, we reported on a potential upcoming Xeljanz recall following a Drug Safety Communication from the U.S. Food and Drug Administration (FDA) regarding new evidence about Xeljanz adverse events in our article, "Will There Be a Xeljanz Recall in the Future?".  We will now provide you with a more in-depth look into the results of the Xeljanz safety trial, or Xeljanz study, that prompted the February 2021 FDA Drug Safety Communication about Xeljanz.

 

Xeljanz Study Results 

On Wednesday, January 27, 2021, Pfizer announced the results from the FDA-mandated Xeljanz safety trial.  This Xeljanz study was composed of a randomized group of 4,362 patients who all had at least one cardiovascular risk factor and were taking either a 5 or 10 mg/day dosage of Xeljanz or a tumor necrosis factor (TNF) inhibitor.  The study found patients taking Xeljanz showed significantly higher rates of adjudicated malignancies when compared with patients taking TNF inhibitors.  Similarly, those taking Xeljanz saw significantly higher rates of major adverse cardiovascular events (MACE) compared to TNF inhibitors. 

According to January 27, 2021 article, "JAK Inhibitor Mises Endpoint in Safety Study. Now What?":

Adverse events were pooled for the two [Xeljanz (tofacitinib)] doses for evaluating the primary endpoints. Incidence rates for MACE were slightly higher with the 10-mg versus 5-mg dose (10.5 vs 9.1 per 1,000 person-years); rates of malignancies did not differ between dosages. Following a signal for increased risk of pulmonary embolism and mortality at the higher dose, patients in the 10-mg arm were moved to the 5-mg dose in early 2019.

Cancer and MACE safety signals had been noted in the drug's clinical trials and later postmarketing reports, leading to cautions on tofacitinib's label, including boxed warning about increased mortality, thrombosis, and lymphoma and other malignancies.

While the complete analysis of the Xeljanz study conducted by Pfizer has not yet been published, the company reports they are working with the FDA to review the Xeljanz safety trial results as they become available.  It is expected the results of the study will yield further data on Xeljanz and pulmonary embolism, mortality, and comparative effectiveness.

Xeljanz is classified as a JAK inhibitor, which works by blocking Janus kinases (JAKs), which is an enzyme that regulates immune cells.  This allows for Xeljanz to fight inflammatory diseases such as rheumatoid arthritis and ulcerative colitis.  Recent studies like the Pfizer report on Xeljanz look into the concern JAK inhibitors may impair the body's ability to fight off dangerous microbes or cancer.

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How Xeljanz Fares Against TNF Inhibitors and Other JAK Inhibitors

According to January 27, 2021 article, "Safety finding weighs on Pfizer's inflammation drug, and could spell trouble for others", the results of the Xeljanz study could have impacts on other JAK inhibitors, and even TNF inhibitors:

Results show that among Xeljanz-treated patients, 98, or 3.37%, had a major cardiovascular event sometime between when they started treatment to 60 days after they stopped. In the TNF group, 37, or 2.55%, experienced such an event. Malignancies, excluding non-melanoma skin cancer, were seen in 122, or 4.19%, of patients given Xeljanz and 42, or 2.89%, of patients given a TNF inhibitor. With regard to Xeljanz, Pfizer said heart attack and lung cancer were the most frequently reported major cardiovascular events and malignancies, again excluding non-melanoma skin cancer.

Other JAK inhibitors since Xeljanz have also been approved for use by the FDA, though some of them also carry Black Box Warnings about infections, thrombosis, and cancer risk.

According to January 27, 2021 article, "Pfizer's big blockbuster Xeljanz flunks its post-marketing safety study, renewing harsh questions for JAK class", Xeljanz may not fare well against TNF inhibitors:

And on Wednesday, Pfizer announced that the six-year study 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.

However, overall it seems we do not have enough data to come to a conclusion about a possible Xeljanz recall or other JAK inhibitors recalls.  According to the same January 27, 2021 article, "Pfizer's big blockbuster Xeljanz flunks its post-marketing safety study, renewing harsh questions for JAK class":

It’s also not yet clear how the new findings will impact JAK inhibitors more broadly. In a note to investors, RBC’s Brian Abrahams said physicians already take safety issues into account when considering JAK inhibitors, but that the new data could make the FDA “even more risk-averse on labeling for the class going forward.” That could impact Incyte as they await the FDA’s decision on a topical formulation for Jakafi, one of the only JAK inhibitors that does not yet have a black box warning.

 

Current FDA Recommendations

Although the FDA has released a safety alert warning patients about the associated risks of Xeljanz, physicians are currently still recommended to continue to follow the recommendations listed in the drug's prescribing information.  Patients are advised not to discontinue Xeljanz use without first consulting their physician.

According to February 2, 2021 article, "FDA warns of increased risk for heart-related issues, cancer linked to Xeljanz", Pfizer is committed to a continued review of results from the recent Xeljanz study:

“Providing information on the safe and effective use of our medicines is imperative,” Tamas Koncz, MD, PhD, chief medical officer for Inflammation and Immunology at Pfizer, said in a company release. “We believe that extensive additional analyses of these study data, and communicating them as soon as possible, will further clarify the benefit and risk profile of tofacitinib to help inform medical decision-making and patient care.”

The FDA is currently recommending health care providers report any adverse events related to Xeljanz to the FDA's MedWatch Safety Information and Adverse Events Reporting Program.

 

Be assured that we will continue to follow this latest Xeljanz drug safety issue as well as watch for possible further FDA regulatory actions, including a possible Xeljanz recall.

 

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Will There Be a Xeljanz Recall in the Future?

FDA Issues New Safety Alert for Serious Heart-Related Problems and Cancer

 

Written by: Lauren Schwab, Legal Assistant

Law Offices of Thomas J. Lamb, P.A.

 

A possible Xeljanz recall may be on the horizon following the release of a February 4, 2021, Drug Safety Communication from the U.S. Food and Drug Administration (FDA) regarding new evidence about Xeljanz adverse events.  This FDA Xeljanz safety alert was issued following the recent release of findings from a safety clinical trial that shows an increased risk of serious heart-related problems and cancer being associated with Xeljanz.

 

Summary of Xeljanz History

In 2012 Xeljanz was approved by the FDA to treat adults with rheumatoid arthritis, and in 2017 the drug was approved by the FDA to treat psoriatic arthritis.  Shortly thereafter, in 2018, the drug was approved by the FDA to treat ulcerative colitis.

By February 2019 through July 2019, safety clinical trials conducted by Xeljanz manufacturer, Pfizer, began to show an increased risk of blood clots and death when taking the drug at a higher dosage of 10mg twice daily.  Patients included in the study were at least 50 years old, and were required to have at least one cardiovascular risk factor.

We reported on the risks of Xeljanz at the higher dosage on our Drug Injury Watch blog in a February 2019 article, "Xeljanz Recommended Dosage For Ulcerative Colitis Patients May Increase Risk Of Pulmonary Embolism":

There appears to be a somewhat "under the radar" drug-safety issue with the 10 mg twice daily recommended dosage of Xeljanz for patients with ulcerative colitis (UC), according to this February 20, 2019 article, "FDA cites an ‘ongoing review’ for Pfizer’s blockbuster Xeljanz, with implications for the class", published by Endpoint News [free subscription required]. 

Given the results of those 2019 safety clinical trials, the FDA mandated a Black Box Warning label for Xeljanz, in part cautioning doctors about the increased risk of blood clots and death associated with Xeljanz.

According to 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)", while the recent safety clinical trial is complete, the FDA is awaiting additional results:

The clinical trial is now complete and initial results show a higher occurrence of serious heart-related events and cancer in RA patients treated with both doses of tofacitinib compared to patients treated with a TNF inhibitor. FDA is awaiting additional results from the trial.

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Plans for a Xeljanz Recall in the Near Future?

The February 2021 Drug Safety Communication about Xeljanz and its association with heart-related problems as well cancer risks is very concerning because it comes on top of the 2019 Xeljanz Black Box Warning.  However, the FDA reportedly will await further information before making any additional Xeljanz label changes or take any other regulatory actions.

According to this February 4, 2021 news report, "No Xeljanz Plan Yet From FDA", it is possible that a Xeljanz recall may be coming in the future, but as of now the FDA is not ready to take action:

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 [i.e., a Xeljanz recall.]

For now, the agency is content with "alerting the public that preliminary results from a safety clinical trial show an increased risk of serious heart-related problems and cancer" relative to tumor necrosis factor (TNF) inhibitors.

Since the analysis of the clinical trials is not yet complete, the FDA has reported it will evaluate the results once received and will communicate its final conclusions and recommendations once the review has been completed.

In the same MedPage Today report, "No Xeljanz Plan Yet From FDA", the Black Box Warning is referenced yet again, though there is no mention of when, or even if, a Xeljanz recall will occur:

[Xeljanz (tofacitinib)] and two other JAK inhibitors already carry boxed warnings about increased mortality, thrombosis, and lymphoma and other malignancies. These were mandated after clinical trials showed numerically higher rates of these events with the drug versus placebo or other comparators. The FDA also ordered a dedicated safety study for [Xeljanz (tofacitinib)] to better understand the risks; it did the same for one of the other JAK inhibitors, baricitinib (Olumiant). It did not do so for the third, upadacitinib (Rinvoq).

Under a REMS, drugmakers might be ordered to provide training for prescribers about the risks, develop special educational materials for patients, and/or require patients to certify they received the materials and understand them.

 

Current Recommendations from the FDA

According to February 2021 Xeljanz Drug Safety Communication issued by the FDA, "Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib)", the current recommendations for Xeljanz are as follows:

Patients should not stop taking [Xeljanz (tofacitinib)] without first consulting with your health care professionals, as doing so may worsen your condition. Talk to your health care professionals if you have any questions or concerns.

Health care professionals should consider the benefits and risks of [Xeljanz (tofacitinib)] when deciding whether to prescribe or continue patients on the medicine. Continue to follow the recommendations in the [Xeljanz (tofacitinib)] prescribing information.

Be assured that we will continue to follow this latest Xeljanz drug safety issue as well as watch for possible further FDA regulatory actions, including a possible Xeljanz recall.

 

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Boston Children's Hospital Offers Alternatives to MiraLAX for Constipation Treatment

MiraLAX Has Been Associated With Neuropsychiatric Problems in Children

 

Written by: Lauren Schwab, Legal Assistant

Law Offices of Thomas J. Lamb, P.A.

 

For the past few years, we have reported on the popular over-the-counter constipation drug MiraLAX, and its adverse side effects in children. While the Food and Drug Administration (FDA) continues to fund research for a potential connection between the two, few advancements have been made in the research.

 

MiraLAX Overview

While many pediatricians have recommended parents use MiraLAX to treat chronic childhood constipation, the drug has yet to be approved by the FDA for use in children.  However, the drug quickly became a topic of discussion amongst parents, as many parents report behavioral and neurological issues in their children that they claim stem from the child's use of MiraLAX.

MiraLAX is typically mixed with eight ounces of water and is meant to be used one to two times daily to treat constipation.  Some individuals notice common side effects, such as loose bowel movements, bloating or nausea, although these side effects typically improve with a dosing adjustment.

 

Boston Children's Hospital Makes Recommendations to MiraLAX Alternatives

The Boston Children's Hospital offers alternatives to MiraLAX, claiming the drug is simply one of the many options when treating chronic childhood constipation.  According to the hospital, lifestyle modification should be the first form of treatment.  This includes increased hydration, high-fiber diets and regular exercise.

According to the Boston Children's Hospital's page entitled, "Division of Gastroenterology, Hepatology and Nutrition - MiraLAX and Other Options for Treating Constipation", other medication alternatives to MiraLAX are also available for constipation treatment:

When lifestyle modifications have been exhausted, medication options for treating constipation include:

• MiraLAX
• lactulose (a non-absorbable sugar)
• magnesium hydroxide (aka Milk of Magnesia)
• senna (an herbal extract that stimulates bowel motions)
• mineral oil 

The hospital stresses these products should only be used if recommended by a trained healthcare professional.

 

Additional Information and Sources

While few advancements have been made in terms of PEG 3350 research in relation to MiraLAX use by children, parents and other family members may find comfort in joining the Facebook group "Parents Against MiraLAX".  Additionally, you may want to consider referring to our February 2020 article, "MiraLAX: The Quest to Get Answers from the FDA"  for more information of past PEG 3350 studies.

As always, we will continue to monitor the issues surrounding MiraLAX and will provide you with any new or relevant information. Please feel free to share any relevant information with us, as well.

 

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Gilenya Associated with Cases of Liver Injury, Including Acute Hepatic Failure Requiring Liver Transplant

January 2021 Drug Safety Update for Gilenya Issued by Medicines and Healthcare products Regulatory Agency

 

Written by: Lauren Schwab, Legal Assistant

Law Offices of Thomas J. Lamb, P.A.

 

Gilenya, a medication used to treat different forms of multiple sclerosis (MS), has updated its advice about the risks of serious liver injury and herpes meningoencephalitis in the UK.  According to a January 2021 Drug Safety Alert issued by the UK's Medicines and Healthcare products Regulatory Agency (MHRA), "Fingolimod (Gilenya▼): updated advice about the risks of serious liver injury and herpes meningoencephalitis", serious and some fatal cases of liver injury, including acute hepatic failure requiring liver transplant have been associated with Gilenya:

A recent European review of safety data identified 7 cases of clinically significant liver injury that developed between 10 days and 5 years after the start of fingolimod treatment, including 3 post-marketing reports of acute hepatic failure requiring liver transplantation. Liver samples showed submassive hepatic necrosis in 2 patients, and one of these samples also contained features of acute hepatitis.

This January 2021 safety update comes after the European Medicines Agency released a review of Gilenya safety data in November 2020, as discussed in our recent blog post, "Gilenya Safety Alert November 2020: Cases of Acute Liver Failure Requiring Liver Transplant".

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According to January 2021 Gilenya MHRA alert, the current advice for healthcare professionals is to monitor liver function tests routinely, both before, during, and after treatment with Gilenya.  Additionally, the article provides advice both for patients exhibiting signs of liver injury, and those without signs of liver injury:

• in patients without signs and symptoms of liver injury, the updated advice is:
  • monitor liver function tests more frequently if serum aspartate aminotransferase (AST) or serum alanine aminotransferase (ALT) levels exceed 3-times the upper limit of normal (ULN) but less than 5-times ULN with a normal bilirubin level
  • discontinue fingolimod if ALT or AST levels exceed 5-times ULN or if they are at least 3-times the ULN and bilirubin is increased – fingolimod may be re-started following a careful benefit-risk assessment of the underlying cause when serum levels have returned to normal
• in patients with symptoms or signs of hepatic dysfunction:
  • check liver function tests urgently
  • discontinue fingolimod if significant hepatic injury is confirmed; further treatment with fingolimod may be considered following recovery only if an alternative cause of hepatic dysfunction is established

We will continue to monitor the Gilenya safety profile with special attention to cases of Gilenya-related liver failure following drug-induced liver injury associated with Gilenya.

 

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Pre-existing Eye Conditions Linked to Beovu-related Adverse Events

Case Study Further Supports Link Between Beovu and Adverse Events

 

Written by: Lauren Schwab, Legal Assistant

Law Offices of Thomas J. Lamb, P.A.

 

Novartis has recently identified patients with pre-existing eye conditions prior to being treated with Beovu as being at higher risk of potentially suffering from vision-threatening adverse events caused by the drug in a recent review. The discovery comes following a February 2020 warning issued by the American Society of Retinal Specialists warning patients of severe vision loss linked to the use of Beovu.

 

What the Novartis Review Found

In the review issued by Novartis, the main risk of experiencing vision-altering side effects such as retinal vasculitis and/or retinal vascular occlusion within the six months after the first administration of Beovu was prior intraocular inflammation and/or vascular occlusion in the year prior to the first injection of Beovu.

In more detail, according to this November 14, 2020, Reuters article, "Novartis identifies possible risk factors for Beovu patients":

The observed overall risk rate of 0.46% for all Beovu-treated patients increased to 3.97% in people who had the conditions before treatment, Novartis said.

Around the world, drug regulators are approving updated safety guidelines aimed at identifying ways to prevent severe vision loss when using Beovu. Novartis continues to uphold its position that Beovu is a valuable and important treatment option for patients with wet AMD, with an overall favorable benefit/risk profile.

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Beovu Case Study: Adverse Events Related to Beovu Injection

As mentioned previously, Beovu has been related to cases of retinal vasculitis and severe vision loss, especially with patients who have a medical history of retinal vasculitis and/or retinal vascular occlusion.  A case study published in the American Journal of Ophthalmology Case Reports in December 2020 outlines the complications a 76-year old had following her Beovu injections.

Approximately one week following her third administration of Beovu, the woman experienced pain, decreased vision, and increased floaters. One month after her last Beovu injection, the patient was switched to Lucentis, a drug also aimed at treating wet AMD. Three weeks following the switch in medication, the patient experienced several adverse side effects including photophobia, pain, and decreased vision. 

According to the December 2020 American Journal of Ophthalmology Case Reports article, "Brolucizumab-related retinal vasculitis with exacerbation following ranibizumab retreatment: A clinicopathologic case study", several adverse side effects were reported:

Examination was significant for 0.5+ anterior chamber cells, vitritis, mild peripheral vascular sheathing, and decreased vision from 20/70 to 20/200....

Examination revealed worsening uveitis, vitritis, vascular sheathing, and decreased vision to count fingers.

Additionally, in the same article, it was concluded the adverse events were in relation to Beovu, with no mention of Lucentis causing the vision-related issues:

Treatment with brolucizumab [Beovu] 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.

 

For a complete list of side effects or more information on Beovu, please visit our Beovu Drug Information Page. 

We will continue to monitor the issues surrounding Beovu and provide you with any new or relevant information.  Please feel free to share any information with us as well.

 

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IPF Drug Esbriet Recalled in Canada Due to Risk of Drug-Induced Liver Injury

 

Esbriet Linked to Adverse Side Effects Concerning Liver Function

 

Written by: Lauren Schwab, Legal Assistant

Law Offices of Thomas J. Lamb, P.A.

 

Esbriet, an anti-fibrotic and anti-inflammatory drug intended for the treatment of idiopathic pulmonary fibrosis (IPF), has recently been linked to the risk of drug-induced liver injury.  IPF can cause the lung tissue to become scarred over time, making it increasingly difficult to breathe. The drug has been recalled by Health Canada in the form of a "Dear Healthcare Professional Letter".

 

Adverse Effects Caused by Esbriet

According to September 14, 2020 recall alert published by HealthCanada, drug-induced liver injury has been reported as an adverse side effect caused by Esbriet, and in rare cases can have serious clinical consequences including death.  The alert advises healthcare professionals to do the following:

• perform liver function tests (ALT, AST, and bilirubin) before initiating treatment with ESBRIET, subsequently at monthly intervals for the first 6 months, and then every 3 months thereafter.
• promptly measure liver function tests in patients who report symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice.
• consider discontinuation or dose adjustments in the event of liver enzyme elevation (see Table in the Information for healthcare professionals section).
• not use ESBRIET in patients with severe hepatic impairment or end-stage liver disease.
• use ESBRIET with caution in patients with pre existing mild to moderate hepatic impairment (Child-Pugh Class A and B).

The majority of reported adverse events occurred within the first 6 months of treatment.

 

Who is Affected by an Esbriet Recall

The recall alert warns patients should discuss any previously existing liver problems with their doctor before taking Esbriet.  Patients with severe or end-stage liver disease should not take Esbriet, as Esbriet may cause liver problems and other abnormal blood test results.

Patients are advised to stop taking Esbriet and to seek immediate medical attention if experiencing any sign of liver injury, such as tiredness, yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting or loss of appetite.

 

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Paragard IUD Associated with Painful Complications

 

Adverse Side Effects and Complications May Lead to Litigation

 

Written by: Lauren Schwab, Legal Assistant

Law Offices of Thomas J. Lamb, P.A.

 

What is Paragard?

The device, meant to be clinically inserted to prevent pregnancy, has been marketed as a safe and effective birth control that allows women to choose when they want to have children without the side effects of other birth control methods. Paragard is considered to be a copper IUD, made up of a plastic base with a copper wire wrapped around it. The Paragard device is claimed to be 99% effective, with the ability to last up to ten years, and must be removed by a doctor.

 

What are the Possible Side Effects and Complications?

Paragard has many side effects, though Teva Pharmaceuticals claims most effects wear off after two to three months of use, a time known as the "adjustment period". These side effects include spotting between periods, longer or heavier periods, pelvic inflammatory disease (PID), expulsion, vaginal discharge, infections, pain during sex, allergic reactions, anemia, menstrual cramps, perforation of the uterus, and/or difficulty removing the device.

If the Paragard device breaks or fractures during removal, women can be seriously injured, as this often requires an additional painful and extensive surgery, or even a hysterectomy. Additionally, if a woman were to become pregnant while the device is implanted, the resulting pregnancy would be ectopic, meaning the fertilized egg is growing outside the main cavity of the uterus, which can lead to life-threatening bleeding and other complications.

 

Have Paragard lawsuits been filed?

The Paragard IUD manufacturers, Teva Pharmaceuticals and Cooper Companies Inc., have come into the spotlight since a New York woman named Vanesha Johnson sued the company after the arm of the device broke off and implanted itself into her during removal.  Johnson claims the company failed to adequately warn both herself and her physician of the risks associated with the device.  As a result of her Paragard use, Johnson claims to have suffered a loss of reproductive health, pain, suffering, mental anguish, loss of enjoyment of life, and financial burden regarding medical bills.

Current Paragard claims involve complications including IUD breakage upon removal, IUD expulsion or falling out of uterus, IUD migration, ectopic pregnancy, IUD embedded in the uterus, infection and/or abscess, inflammation caused by copper left in body, perforation of uterine wall or cervix, scarring and damage to other organs, surgeries, hysterectomies, infertility, or death.

 

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Beovu Safety Issues Have Impacted Novartis Share Price

Novartis Facing Financial Struggles and Challenges Getting Doctors on Board with Beovu

 

Written by: Lauren Schwab, Legal Assistant

Law Offices of Thomas J. Lamb, P.A.

 

After a series of intraocular inflammation events related to Beovu were reported to the drug's manufacturer, Novartis, the company decided to conduct a safety review aimed at investigating the incidents, some of which led to severe vision loss.  The assessment completed by the independent Safety Review Committee on April 8, 2020, concluded there is a confirmed safety signal of rare adverse events. The subsequent label change and issues surrounding Beovu may have impacted Novartis' share value.

 

Financial Issues for Novartis

Additionally, Novartis' CEO released a statement admitting the COVID-19 pandemic has made it increasingly difficult to value takeover candidates. In "Novartis CEO says COVID-19 makes valuing takeover targets tougher", an August 2020 article written for Reuters, Novartis Chief Executive Vas Narasimhan expressed his disappointment with the company's development of drugs aimed at fighting COVID-19:

Narasimhan, a U.S. citizen who took over two years ago as CEO, acknowledged disappointment that Novartis’ existing medicines had not proven more useful against COVID-19. For instance, the company, like others, abandoned a trial of its older malaria medicine hydroxychloroquine after it failed to help patients in scientific studies.

 

Moreover, he said Novartis had hoped to be faster in developing new drugs against COVID-19 and could have potentially profited from more cooperation with smaller biotech companies. “We concentrated more on our own in-house activities - and learned a lesson from it,” he said....

 

Novartis’ share price has fallen 15% this year, compared to peer Roche Holding AG’s 2% rise.

In addition to the potential financial impact of COVID-19 on Novartis, CEO Narasimhan expressed belief safety issues related to Beovu may have cost Novartis shares nearly 10% of their value.

 

Doctors Reluctant to Fully Embrace Beovu

Additionally, Novartis is seemingly having a difficult time getting eye doctors to fully embrace Beovu, a claim made in a September 2020 Fierce Pharma article, "Novartis, Roche fined $526M in France for alleged Lucentis marketing missteps":

Novartis, meanwhile, has been struggling to persuade eye doctors to embrace Beovu, which was approved in the U.S. last October and in the EU in February. But that same month, the American Society of Retina Specialists flagged 14 cases of retinal vasculitis reported among Beovu patients, most of which were serious enough to put them at risk of vision loss.

It was enough to prompt eye doctors surveyed by Piper Sandler to drastically reduce their estimates for Beovu’s market share potential; after initially predicting it could grab 17% share by August, they revised that prediction downward to just 8.4%. The docs predicted “anger and mistrust of [Novartis], indicating an uphill battle," Piper Sandler analysts wrote in a note to clients.  (Emphasis added)

Sales of Beovu fell from $68 million in the first quarter of this year to $34 million in the second. COVID-19 shutdowns didn’t make selling eye drugs any easier: Novartis reported that in the second quarter, Lucentis sales dropped 25% year over year to $401 million.

 

For a complete list of side effects or more information on Beovu, please visit our Beovu Drug Information Page. 

We will continue to monitor the issues surrounding Beovu and provide you with any new or relevant information.  Please feel free to share any information with us as well.

 

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FDA At Standstill in MiraLAX Research With Children's Hospital

Few Advancements Made In PEG 3350 MiraLAX Research

 

Written by: Lauren Schwab, Legal Assistant

Law Offices of Thomas J. Lamb, P.A.

 

For the past few years, we have reported on the adverse reactions of the popular over-the-counter constipation drug MiraLAX.  There are many reports of a potential connection between Polyethylene Glycol (PEG 3350), the active ingredient in this constipation medication, and the development of neuropsychiatric problems.  The FDA continues researching the potential connection between the two, with few advancements made.

 

The FDA's Current Position

Currently, there are no products approved by the FDA for the relief of occasional constipation in pediatric patients.  However, in 2014 the FDA provided the Children's Hospital of Philadelphia (CHOP) with a grant to study the effects of PEG 3350, the active ingredient in constipation medications like MiraLAX, on pediatric patients.  The study was aimed at seeing the extent to which pediatric patients may absorb smaller molecules found in PEG 3350.  Unfortunately, the grant period ended on September 20, 2019, before the study was completed.

However, the FDA continues to express interest in completing the study, and is currently looking to secure funding in order to collect additional samples, continue data analysis and draft a manuscript expressing the study's findings.  More information on the study can be found in this March 2017 pamphlet released by CHOP.  There is no current end date on the study.

 

Research vs Personal Narratives

While few advancements have been made in terms of PEG 3350 research, many studies continue to support the notion that it is still the best drug on the market for pediatric use of constipation relief.  As seen in the March 2017 CHOP informational pamphlet:

PEG 3350 has been studied in children and is often considered the best drug for constipation (see next page). Many children have been treated for months to years.

This idea is further supported in other research articles, such as in a North American Society For Pediatric Gastroenterology, Hepatology & Nutrition January 2015 document "Polyethylene Glycol 3350 (PEG 3350) Frequently Asked Questions":

Is PEG 3350 safe for use in children long-term?
Several research studies have shown PEG 3350 to be safe in children when used for several weeks to several months.  Currently there have been no studies specifically on the use and safety of PEG 3350 in children for longer periods of time.  In clinical practice, however, it is common for pediatric gastroenterologists to prescribe PEG 3350 for chronic use and there have been no reports of serious, long-term side effects in the medical literature.

Why, then, is PEG 3350 and MiraLAX continued to be reported as "safe" for pediatric patients by these research articles if the concerns of parents and family members about long-term side effects continues to grow?

 

Additional Information and Sources

While few advancements have been made in terms of PEG 3350 research in relation to MiraLAX, parents and other family members may find comfort in joining the Facebook group "Parents Against MiraLAX".  Additionally, you may want to consider referring to our February 2020 article, "MiraLAX: The Quest to Get Answers from the FDA"  for more information of past PEG 3350 studies.

As always, we will continue to monitor the issues surrounding MiraLAX and will provide you with any new or relevant information. Please feel free to share any relevant information with us, as well.

 

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Off-Label Use of Belviq for Seizure Control in Dravet's Syndrome Patients to Continue

FDA Agrees to "Expanded Access" Program for the Drug

 

Written by: Lauren Schwab, Legal Assistant

Law Offices of Thomas J. Lamb, P.A.

 

Since its approval by the FDA in 2019, Belviq has been used to treat obesity. The drug had also commonly been used to treat Dravet Syndrome, also known as Severe Myoclonic Epilepsy of Infancy (SMEI), which is a rare form of intractable epilepsy that begins in infancy.  It is common for physicians to prescribe medication for "off-label" use for rare diseases such as Dravet Syndrome.

 

Belviq Taken Off the Market, With Some Exceptions

On February 13, 2020, the FDA announced Eisai, the drug manufacturing company for Belviq, agreed to withdraw the drug from the U.S. market due to clinical trial results that showed an increased risk of cancer associated with Belviq.  According to a February 2, 2020, Drug Safety Communication released by the FDA:

When FDA approved lorcaserin in 2012, we required the drug manufacturer to conduct a randomized, double-blind, placebo-controlled clinical trial to evaluate the risk of cardiovascular problems, which found that more patients taking lorcaserin (n=462; 7.7 percent) were diagnosed with cancer compared to those taking a placebo, which is an inactive treatment (n=423; 7.1 percent). The trial was conducted in 12,000 patients over 5 years. A range of cancer types was reported, with several different types of cancers occurring more frequently in the lorcaserin group, including pancreatic, colorectal, and lung.

 

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Many Dravet Syndrome patients became concerned regarding the removal of Belviq from U.S. markets, however, the Dravet Syndrome Foundation said in a February 2020 statement that they have worked alongside Eisai to make an exception for Dravet Syndrome patients:

DSF Scientific Director, Nicole Villas, along with our Medical Advisory Board reached out to Eisai on behalf of DSF and our community. Eisai heard these concerns and spoke with the FDA about continuing to supply Belviq to patients with Dravet syndrome who benefit from this medication. 

 

The Future of Belviq for Dravet's Syndrome Patients

Following the Dravet Foundation's work with Eisai, the FDA agreed to an "Expanded Access" program in order to allow for continued use of Belviq for Dravet Syndrome patients, despite the recent withdrawal from the market as an obesity drug. According to a February 2020 statement by the Dravet Foundation:

Eisai and the FDA have agreed to proceed with expanded access for Belviq (lorcaserin) for Dravet syndrome patients. Physicians with patients on Belviq can reach out to Eisai at esi_medinfo@eisai.com for information on how to enroll their patient in the centralized Expanded Access program.

 

For people with possible Belviq lawsuits -- personal injury or wrongful death -- we encourage them to submit a Belviq Case Evaluation Form.  It is free, confidential, and there is no obligation.

Of course, we will continue to monitor the medical research for more information about the specific types of cancer cases associated with Belviq.

 

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