Drug Safety Developments

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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Belviq

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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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Diabetes Drugs Invokana, Jardiance and Farxiga Associated with Fournier's Gangrene

Necrotizing Faciitis of the Perineum Linked as Side Effect of SGLT2 Inhibitor Drugs

 

Written by: Lauren Schwab, Legal Assistant

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

 

Diabetes drugs in the sodium-glucose cotransporter 2 (SGLT2) inhibitors class are associated with Fournier's Gangrene, or necrotizing fasciitis of the perineum. Drugs within this class include, but are not limited to, Invokana (canaglifozin), Jardiance (empaglifozin), and Farxiga (dapagliflozin).

 

History of SGLT2 Drugs and Fournier's Gangrene

According to an August 29, 2018, Drug Safety Communication, "FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes”:

Fournier’s gangrene is an extremely rare but life-threatening bacterial infection of the tissue under the skin that surrounds muscles, nerves, fat, and blood vessels of the perineum....

In the five years from March 2013 to May 2018, we identified 12 cases of Fournier’s gangrene in patients taking an SGLT2 inhibitor...All 12 patients were hospitalized and required surgery. Some patients required multiple disfiguring surgeries, some developed complications, and one patient died. In comparison, only six cases of Fournier’s gangrene (all in men) were identified in review of other antidiabetic drug classes over a period of more than 30 years.

Similarly, a May 2019 FDA analysis article provides more evidence of Fournier's gangrene in association with SGLT2 Inhibitor diabetes drugs. The article, published by the medical journal Annals of Internal Medicine, entitled "Fournier Gangrene Associated With Sodium-Glucose Cotransporter-2 Inhibitors" states:

The FDA identified 55 unique cases of FG in patients receiving SGLT2 inhibitors between 1 March 2013 and 31 January 2019... Time to onset after initiation of SGLT2-inhibitor therapy ranged from 5 days to 49 months. All patients had surgical debridement and were severely ill...

FG is a newly identified safety concern in patients receiving SGLT2 inhibitors. Physicians prescribing these agents should be aware of this possible complication and have a high index of suspicion to recognize it in its early stages.

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Invokana / Farxiga / Jardiance

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Moving Forward and Potential Legal Action

The FDA is currently advising patients to seek immediate medical attention if they are experiencing symptoms of Fournier's gangrene. According to the August 29, 2018, Drug Safety Communication, "FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes”:

Patients should seek medical attention immediately if you experience any symptoms of tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, and have a fever above 100.4 F or a general feeling of being unwell. These symptoms can worsen quickly, so it is important to seek treatment right away.

Health care professionals should assess patients for Fournier’s gangrene if they present with the symptoms described above. If suspected, start treatment immediately with broad-spectrum antibiotics and surgical debridement if necessary. Discontinue the SGLT2 inhibitor, closely monitor blood glucose levels, and provide appropriate alternative therapy for glycemic control.

 

We will continue to monitor the current drug safety issue of Fournier's gangrene in relation to patients using SGLT2 inhibitor drugs such as Invokana, Jardiance and Farxiga. We are currently evaluating Fournier's Gangrene cases and possible drug injury lawsuits against the responsible pharmaceutical companies.

 

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FDA Announces Elmiron Drug Safety-Related Labeling Changes

Updated Label to Include Retinal Pigmentary Changes

 

Written by: Lauren Schwab, Legal Assistant

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

 

Elmiron (pentosan polysulfate sodium) was approved by the FDA on September 26, 1996, for the treatment of painful bladder syndrome (interstitial cystitis).  More recently, however, Elmiron has been linked to cases of eye damage and vision-related injuries. 

In my previous June 8, 2020, article, "Elmiron Potentially Linked to Severe Eye Disorders", I addressed the Elmiron label, which at the time still stated "Warnings: None".  Since the publication of this article, the FDA has released information on a label change for Elmiron, so that retinal pigmentary changes will be added to the label as a potential adverse reaction.

 

Recent FDA Label Change

On June 16, 2020, the FDA released information regarding an Elmiron label change.  The label was updated to include retinal pigmentary changes, otherwise known as pigmentary maculopathy, to the "Warnings and Precautions" as well as the "Adverse Reactions" sections of the label.  The symptoms of this adverse reaction were cited to include difficulty reading, slow adjustment to low or reduced light environments and blurred vision. An announcement from the FDA released on June 16, 2020, on the matter states:

Pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of ELMIRON® (see ADVERSE REACTIONS). Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use.  While the etiology is unclear, cumulative dose appears to be a risk factor.

The FDA also now recommends that patients receive retinal examinations including optical coherence tomography (OCT) and auto-fluorescence imaging within six months of starting Elmiron, and then periodically while continuing long-term treatment.

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Elmiron

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Leading Up to The Label Change

A 2018 study published by the Journal of Ophthalmology showed a link between Elmiron (pentosan polysulfate sodium or PPS) and pigmentary maculopathy:

We describe a novel and possibly avoidable maculopathy associated with chronic exposure to PPS. Patients reported symptoms of difficulty reading and prolonged dark adaptation despite generally intact visual acuity and subtle funduscopic findings. Multimodal imaging and functional studies are suggestive of a primary RPE injury. Additional investigation is warranted to explore causality further.

Similarly, a follow-up July 2019 study published by the Review of Ophthalmology showed findings of Elmiron related maculopathy:

We recently identified a unique pigmentary maculopathy in a cohort of patients who were receiving chronic pentosan polysulfate sodium therapy (Elmiron, Janssen Pharmaceuticals, Titusville, New Jersey), a popular medication for interstitial cystitis. Upon presentation to our clinic, these patients carried tentative diagnoses, including age-related macular degeneration and pattern dystrophy.

The findings of these studies, and other studies like them may be what led the FDA to requiring an Elmiron label change. Janssen Pharmaceuticals had made

Our law firm is currently investigating cases involving a vision-related Elmiron side effect as a possible drug injury lawsuit against the responsible pharmaceutical companies.

 

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Beovu Label Change Approved After Confirmation of Rare Adverse Side Effects

Retinal Vasculitis and Retinal Vascular Occlusion to be Added to Beovu Label

 

Written by: Lauren Schwab, Legal Assistant

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

 

After a recent external safety committee review of Beovu, several adverse side effects of the drug were found that may lead to severe vision loss. The FDA recently approved a label change for Beovu to include "Retinal Vasculitis and/or Retinal Vascular Occlusion" to the Warnings and Precautions section of the Prescribing Information for Beovu.

Recent Adverse Side Effects of Beovu Confirmed

Since Beovu's approval by the FDA in October 2019, Novartis has received 14 reports of vasculitis occurring in patients who received the drug for treatment of wet age-related macular degeneration. Novartis, the manufacturing company for Beovu, confirmed a safety signal of rare adverse events including retinal vasculitis and retinal vascular occlusion. Both retinal vasculitis and retinal vascular occlusion can lead to severe vision loss.

The adverse events typically occurred in patients who showed signs of intraocular inflammation. Physicians are being advised to look for signs of intraocular inflammation before injecting Beovu, and should not administer the drug if signs of intraocular inflammation are present, according to a press release by Novartis.

 

Novartis' Findings on Adverse Side Effects

According to a June 2020 article written for Ocular Surgery News, the cases of Beovu-related retinal vasculitis and retinal vascular occlusion are rare:

According to post-marketing data, retinal vasculitis, retinal vascular occlusion or retinal vasculitis plus retinal vascular occlusion were evident in every 6.99 per 10,000 injections. Retinal vasculitis was evident in 1.69 per 10,000 injections, retinal vascular occlusion was evident in 1.57 per 10,000 injections, and retinal vasculitis plus retinal vascular occlusion was evident in 3.73 per 10,000 injections.

However, both retinal vasculitis and retinal vascular occlusion can lead to severe vision loss and even blindness.

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Beovu

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Label Change Expected

According to a June 11, 2020, Press Release by Novartis, the company is currently working with the FDA to make label changes and updates to the prescribing information for the drug:

Novartis announced today that the US Food and Drug Administration (FDA) has approved a label update for Beovu (brolucizumab) to include additional safety information regarding retinal vasculitis and retinal vascular occlusion.

A recent Beovu Label Change Approval Letter released by the FDA on June 9, 2020, notes the changes that are to be expected in the coming weeks:

This Prior Approval supplemental biologics application provides for the addition of “Retinal Vasculitis and/or Retinal Vascular Occlusion” to the Warnings and Precautions section of the Prescribing Information.

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.

 

Drug Injury Watch: Side Effects News & Reports

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Elmiron Potentially Linked to Severe Eye Disorders

Elmiron Side Effects Include Macular Degeneration and Pigmentary Maculopathy

 

Written by: Lauren Schwab, Legal Assistant

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

 

Elmiron (pentosan polysulfate sodium) was approved by the FDA on September 26, 1996, for the treatment of painful bladder syndrome (interstitial cystitis). More recently, however, Elmiron has been linked to cases of eye damage and vision-related injuries. 

 

Elmiron Studies on Side Effects

Several studies, including a May 2018 study and an April 2019 study conducted by Emory Eye Center, have shown a connection between Elmiron and severe eye disorders, such as macular degeneration (maculopathy), more specifically pigmentary maculopathy. Macular degeneration is a serious eye disorder, typically classified by symptoms such as central vision loss, blurred, dimmed or spotty vision, prolonged dark adaptation, and blindness.

According to a report from Science Direct, Kaiser Permanente conducted a study reviewing medical records from nearly 4.3 million patients taking Elmiron. The study found that as the quantity and dosage of Elmiron increased, so did the amount of the patient's eye damage, i.e., dose-response relationship.

 

Label Warning Discrepancies

The underlying claim for Elmiron lawsuits being filed against the manufacturing company Janssen Pharmaceuticals and other drug companies is a failure to properly warn doctors and patients about the potential risks of vision problems associated with Elmiron.

Despite claims of eye damage from Elmiron, the label and prescribing information for Elmiron in the US remarkably still states "Warnings: None". In October 2019 Health Canada required the Elmiron label to be changed,with pigmentary maculopathy added to the "Warnings and Precautions", "Post-market Adverse Drug Reactions", and "Consumer Information" sections of the label. The United States, however, the FDA has not required any such changes be made to the Elmiron label.

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Elmiron

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Case Criteria and Current Litigation

There are currently several pending Elmiron lawsuits. The first lawsuit was brought against Teva Branded Pharmaceutical Products R&D, Teva Pharmaceuticals USA, Inc., Janssen Pharmaceuticals, Inc, and Johnson & Johnson, Inc.  This Elmiron lawsuit in the United States District Court for the District of Connecticut. 

The typical Elmiron lawsuit involves a woman between the ages of 30 to 60 who had ingested Elmiron for at least one year at a dosage of at least 100mg. The patient who is the plaintiff in the Elmiron lawsuit was diagnosed with a vision-related Elmiron side effect such as wither pigmentation maculopathy, pigmentation macular degeneration, pigmentation maculitis, retinal maculopathy or dry macular degeneration. Significantly, the patient does not need to be taking Elmiron up until the time of their Elmiron side effect diagnosis, unlike most drug injury cases.

Our law firm is currently investigating cases involving a vision-related Elmiron side effect as a possible drug injury lawsuit against the responsible pharmaceutical companies.

 

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Tasigna's Potential Effects on Treating Parkinson's Disease

Despite Side Effects, Does Tasigna Provide Any Medical Benefit to Parkinson's Disease Patients?

 

Written by: Lauren Schwab, Legal Assistant

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

 

Recent studies on Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) drug Tasigna (nilotinib) have shown it has no significant effects on individuals with Parkinson's disease. 

 

Studying Tasigna's Effects On Parkinson's Disease

According to a May 2020 Medpage Today article, "Leukemia Drug for Parkinson's: A Second Look", researchers have found:

Over 6 months, [Tasigna (nilotinib)] had no effect on symptoms or disease progression in people with moderate to advanced Parkinson's in the phase IIa study, though it appeared safe and tolerable at both 150 mg and 300 mg doses in a population with very stringent inclusion criteria, reported Tanya Simuni, MD, of Northwestern University in Chicago.

The study came about following a small, proof-of-concept study regarding the effects of Tasigna on Parkinson's patients conducted by researchers at Georgetown University in 2016. The Georgetown study suggested possible benefits of the drug on the motor function and quality of life of Parkinson's patients.

 

Tasigna's Safety and Tolerability

Currently, Tasigna is approved by the FDA for adult or pediatric patients diagnosed with Ph+ CML in the chronic phase, adult patients diagnosed with Ph+ CML resistant or intolerant to prior therapy that included imatinib, or pediatric patients diagnosed with Ph+ CML with resistance or intolerance to prior tyrosine-kinase inhibitor (TKI) therapy. Recently, there have been studies examining the impact of the drug on Parkinson's patients, though it is not currently approved by the FDA for use by patients afflicted by Parkinson's disease.

The study found that most Parkinson's disease patients found the drug to be tolerable, despite its lack of potential benefits. The drug was found to be tolerable at both the 150 mg and 300 mg doses, however one treatment-related serious adverse event did occur within the 300 mg group.

 

Tasigna's Side Effects and Potential Dangers

Tasigna has been linked to some serious drug side effects.  One is atherosclerosis, a disease that results in the thickening, hardening, and blocking of the arteries due to a buildup of plaque. In addition, Tasigna's side effects include heart attacks, strokes, lower limb amputations, aneurysms, and more.

For a complete list of side effects or more information on Tasigna, please visit our Tasigna drug information page. 

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

 

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