Drug Safety Developments

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 [email protected] 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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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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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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