Drug Safety Developments

Xeljanz Safety Concerns and New Precautions

 

Written by: Laura Beasley, Legal Assistant

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

 

You may have read our previous articles about Xeljanz and its risk of leading to Pulmonary Embolism or even death.  In June, we posted "Xeljanz Related Blood Clots Can Cause Pulmonary Embolism (PE) Or Deep Vein Thrombosis (DVT) With Patient Deaths Possible" that provides information on the serious side effects found out through a post-marketing study on the drug.  The FDA has finally put in place the “Black Box Warning" to draw attention to these serious risks.

 

Treatment and Trials

Xeljanz can be used to treat ulcerative colitis as well as psoriatic or rheumatoid arthritis.  The recent article, “FDA Requires Box Warnings for Pfizer Drug Xeljanz”, relays information from the FDA that the 10 mg dosage twice a day should not be used for the aforementioned types of arthritis, just ulcerative colitis.  Even further, it should only be used for ulcerative colitis if other medications are not sufficient for the patient.

The use of Xeljanz for the treatment of rheumatoid arthritis was discussed in the Milwaukee Journal Sentinel article, “FDA puts stringent warning on the Pfizer drug Xeljanz because of clots and deaths”, noting that:

The FDA also released data from a safety trial of the drug in people with rheumatoid arthritis, showing there were 19 blood clots in the lungs in those who got higher-dose Xeljanz compared with three who got other drugs known as TNF blockers. There also were 45 deaths in those who got high-dose Xeljanz compared with 25 who got TNF blockers.

The "Black Box Warning" came five months after this clinical trial.  The FDA has received public criticism, such as from physician Michael Carome with Public Citizen, for "moving more slowly and less aggressively to protect public health relative to regulators in other countries"

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New Safety Precautions

Medscape also just published an article on the subject, “FDA Adds Boxed Warning on Risk for PE, Death With Higher Dose Tofacitinib (Xeljanz)”, which reports that in May, health officials in Europe had already advised physicians against the twice a day 10 mg dose of the medicine due to high risk of PE.

Edward V. Loftus, Jr., MD, the Chief Medical Editor of Healio Gastroenterology and Liver Disease, notes:

Based on what I have read, I do not know what the actual magnitude of that risk is, in other words, what’s the relative risk or absolute risk for thromboembolism?

But, there must have been some signal at the higher dose that they saw this signal and so, the European's put out the warning and now the FDA is basically putting out the same warning and they are making it a boxed warning.

While this is confusing, we just have to be cognizant of the warning, which is use the lowest dose possible that keeps your patient in remission.

 

As more information and developments arise regarding the safety of Xeljanz, we will make sure to provide updates whenever possible.

You can visit our law firm's website to submit a free case evaluation if you think you or someone you know may have a personal injury or wrongful death lawsuit as a result of Xeljanz side effects. 

Textured Breast Implants Ban: Will the FDA Reevaluate?

 

Written by: Laura Beasley, Legal Assistant

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

As we have continuously discussed here, textured breast implants are being banned in some countries not including the U.S. You can refer to our most recent previous article on the topic, “U.S. FDA Refrains from Textured Implants Ban”, to explore what has happened thus far worldwide as regards banning textured breast implants due to the risk of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).

 

The FDA’s Reasoning

It is our understanding that the FDA is choosing to not ban textured breast implants in the U.S. due to the lack of a strong causal relationship between this particular type of implant and BIA-ALCL.

In March of this year, the FDA sent out warning letters to both Allergan and Mentor because they did not conduct the necessary post-approval study requirements. An April 2019 article of ours, “March 2019 FDA Meeting on Breast Implants: A Summary Of What You Need To Know”, can provide you with the information contained in the warning letters and details about the post-approval studies.

 

Statements from the Manufacturers

Healio just published an article, “FDA weighs breast implant risks, benefits amid links to cancer, other illnesses”, which includes statements from representatives of both Allergan and Mentor defending their companies’ products.

Both vice presidents from Allergan and Mentor / Johnson & Johnson have expressed similar thoughts about their companies' products in response to the FDA's warning letters. Essentially, they both vouch that their breast implants are monitored and supported by large and long-term clinical studies. In response to the warning about their memory shape implants, Raina Dauria of Mentor / Johnson & Johnson adds:

The use of textured devices in the U.S. has decreased substantially, and Mentor has been challenged in enrolling this study group, despite taking steps to increase enrollment.

As regards the general discussion of potential risk of BIA-ALCL, Stephanie Manson Brown, MD, of Allergan shares: 

Patients with BIA-ALCL can have an excellent prognosis when identified early and treated appropriately... the leading hypothesis centers around biofilm and there are three likely factors that contribute to this, including procedure, product and patient.

This May 2019 Helio article also discusses the onset of symptoms of BIA-ALCL, from the perspective of The University of Texas MD Anderson Cancer Center, with delayed seroma as apparently being the most prominent symptom. Mark Clemens, MD, notes the association between specific brands of implants and the risk of BIA-ALCL. That risk is apparently 7.1 to 8.3 times higher with Allergan Biocell implants compared to all other manufacturers combined.

Canada in Contrast

Allergan may have only received a warning letter in the U.S., but in Canada its sales are being put to a halt. Two days ago Canada’s government website published the article, “Health Canada suspends Allergan's licences for its Biocell breast implants after safety review concludes an increased risk of cancer”, which informs that Health Canada has determined a much higher risk of BIA-ALCL in relation to macro-textured implants, this being 85% of the 26 confirmed cases in Canada. As a result, they have suspended the sale and import of Allergan’s Biocell breast implants and Allergan is voluntarily recalling such unused implants.

An article from Reuters published on the same day, “Allergan to recall textured breast implants in Canada” delivers this quote:

Health Canada’s decision is in contrast to public rulings and positions by other regulatory bodies around the world, including the U.S. Food and Drug Administration’s (FDA) recent position, Allergan said.

With such a strong conclusion from Health Canada regarding the risk of BIA-ALCL from textured implants and the hundreds of women who have been diagnosed, even some deaths occurring, we should wonder... is the FDA going to change its mind?

 

We encourage you to visit our Breast Implants Lymphoma Cancer page on our website for more information on the topic of breast implants and BIA-ALCL.

U.S. FDA Refrains from Textured Implants Ban

 

Written by: Laura Beasley, Legal Assistant

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

 

In our most recent article on breast implants and their link to Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), “Textured Breast Implants Bans on the Rise” we left off wondering whether or not the U.S. was going to follow in the footsteps of Canada and France as regards banning textured implants.

 

No Ban in the U.S.- Why?

As of early May, we can now confirm that the U.S. will not be part of the ban at the current time.

The New York Times provided us with an article on May 2, 2019, “F.D.A. Won’t Ban Sales of Textured Breast Implants Linked to Cancer” which informs us that while most BIA-ALCL cases have occurred in relation to textured implants, the risk and data is still too low to prompt a ban. Smooth implants cannot be disregarded as a potential cause for the rare lymphoma.

This may have you questioning whether or not a ban on textured implants should occur, since the potential risks have been made well-known and other countries have already banned them. This May 2019 New York Times article educates us that, “Only about 10 percent of the implants used in the United States are textured, but in other countries the figure can be as high as 80 percent” 

Additionally, on May 3, 2019, The Washington Post published an article, “FDA won’t ban breast implants linked to cancer at this time” which shared information similar to the article from The New York Times, but gives some additional insight:

The FDA does not believe the product — a kind of textured implant — meets the legal standard for being banned at this time, based on available data and information, according to a statement issued Thursday by Amy Abernethy, FDA principal deputy commissioner, and Jeffrey Shuren, director of the agency’s Center for Devices and Radiological Health.

Measures to be Taken Rather than a Ban

An NBC news article from May 3, 2019, “FDA will not ban textured breast implants at this time” tells us that the FDA plans to make label changes and requirements for reporting incidents:

The agency says it plans to work with patient groups and manufacturers to make changes to the labels of textured implants that could include a black box warning - the FDA’s strictest caution. Manufacturers will also be required to submit adverse event reports instead of the current practice of quarterly summary reports, and details of these will now be made available to the public.

The May 2019 Washington Post article reiterates the possibility of the black-box warning to come and adds that the FDA “may require doctors and patients to sign risk checklists to make sure patients have the necessary information to make an informed decision.”

In furtherance, the FDA is going to require individual medical device reports to be filed by the manufacturing companies if any problems occur with the breast implants. This will ensure that the presence of these breast implant problems is made more available to the public.

 

Even without an FDA ban, it seems like women may steer away from textured implants altogether now because of the associated risks. Rest assured that we will continue to monitor the situation of textured breast implants and report any new information as regards the FDA's plan considering there will be no ban. You can visit our Breast Implants Lymphoma Cancer page on our website for more information on the topic.

MiraLAX: Official Science Effort Regresses while the Public's Investigation Progresses

 

Written by: Laura Beasley, Legal Assistant

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

 

Recent Communication with the FDA and CHOP

If you have kept up with our previous articles on MiraLAX, or follow the issue in general, you may have noted the ongoing delay in the Children's Hospital of Philadelphia (CHOP) PEG 3350 study and the lack of information from both CHOP and the FDA on the matter. Refer to our earlier article, “Efforts to Advance MiraLAX Studies and Innovations to Inform the Population”, to grab some details of the study.

Now it appears the same problem is occurring. Those who advocate for and investigate the MiraLAX issue have been in communication with CHOP and the FDA, urging both to provide some sort of an answer as to what is going on with the CHOP study. Ultimately, why children still are not even enrolled when the study was supposed to be completed in 2018.

The FDA’s press has said, “assays required to analyze the data that will be gathered raise novel scientific issues and will be challenging to develop...the FDA is providing additional assistance with this... we have asked CHOP to give more frequent updates”

Meanwhile, a representative from CHOP has said they are, “actively working with the FDA to finalize methods of this study and an announcement will be made once we start enrolling patients”

 

FAERS and OpenFDA Inconsistencies

It has come to our attention that running MiraLAX and polyethylene glycol (PEG) 3350 on the FDA Adverse Event Reporting System (FAERS) and OpenFDA gives very different results. FAERS shows the total cases for MiraLAX at 24,413 and PEG 3350 at 26,924. On the other hand, OpenFDA shows the total reports in its database for MiraLAX at 43,340 and PEG 3350 at 64,125.

This huge data discrepancy was sent to the Center for Drug Evaluation and Research as an inquiry. The response was that, “All data in FAERS public dashboard is based on FAERS data. We are not familiar with the source for OpenFDA reports. FAERS public dashboard shows ONLY suspects [sic] drugs. That could be one of the reasons for the discrepancy since OpenFDA could show both suspect and concomitant [drugs].”

 

Film for Thought

An upcoming film, "My Kid is Not Crazy", takes an interesting perspective on the issue of neuro-psychiatric problems in young children.

Dr. Susan Swedo with the National Institute of Health dedicated her time to researching, understanding, and finding the cure for the condition she calls “Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcal Infections (PANDAS)” You can visit the film’s website to learn more about what PANDAS is.

It appears the main takeaway that the audience will get from this film is that children who develop the symptoms of PANDAS may often be diagnosed with a mental illness. As a result, they may be given medications or other treatments to combat their “neuropsychiatric issue”. Doctors are quick to settle on such a diagnosis and pharmaceutical companies are happy to make money off of the medications.

To understand how this film relates to the MiraLAX issue, you can read the May 2017 article of ours, “Growing Concern About Reports Of Children Who Developed Neuro-Psychiatric Problems After Taking MiraLAX”. Both PANDAS and MiraLAX present the same sort of issue in the behavior of young children.

 

We will continue to monitor the MiraLAX issue, including new developments and study updates. As always, we are open to any relevant information parents and medical researchers may have and intend to keep the public as informed as we are. 

 

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Textured Breast Implants Bans on the Rise

 

Written by: Laura Beasley, Legal Assistant

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

 

As previously stated, we have been keeping up with what is going on as regards the dangers of breast implant procedures in relation to the rare blood cancer, Breast Implant-Associated Anaplastic Large Cell Lymphoma. For more a more extensive background of BIA-ALCL in relation to breast implants, visit our Breast Implants Lymphoma Cancer page on our law firm's website.

 

Numbers Update

An NBC News Article, “French authorities call for ban of Allergan textured breast implants” provides us with recent data on this issue. The number of BIA-ALCL diagnoses has gone from one per million to one per 2,832. The total number of cases now is 457 in the U.S. and approximately 700 worldwide. The number of deaths has risen from 9 to 16.

 

BIA-ALCL Education is a Necessity

Earlier this month, a MedPage Today article, “Breast Implant-Associated Lymphoma on the Rise” asserts the need for doctors and patients to understand the risks, signs, and symptoms of BIA-ALCL prior to any breast implant procedure, but especially ones with textured implants. This way, patients are able to give educated, informed consent before undergoing a procedure. Patients have been previously misdiagnosed due to the lack of awareness or failure to conduct appropriate practice recommendations. The earlier BIA-ALCL is diagnosed, the better. 

 

Ban on Textured Implants

The February 2019 NBC News Article informs that in the beginning of February, France banned Allergan’s textured breast implants. 85% of the French market comes from textured breast implants, but they have become too increasingly associated with BIA-ALCL. The ban was put in place two days after the FDA’s public investigatory hearing regarding the health risks surrounding breast implant devices. You can refer to our recent article from early April, “March 2019 FDA Meeting On Breast Implants: A Summary Of What You Need To Know” for a concise version of what took place at the meeting.  

We learn from the ICIJ article, “Canada Halts Sales of Cancer-Linked Breast Implants, as Global Scrutiny Grows” that now two more countries, Canada and the Netherlands, are following France's decision.

A recent February article of ours, “Breast Implants Lymphoma Cancer Cases Updates For United States And Canada: February 2019" provides information as to the earlier stages of this issue in Canada. Now, Canada has announced its plans to ban textured breast implants, with intent from Health Canada to alert Allergan of the upcoming suspension of implant sales. 

In the Netherlands, the Dutch National Plastic Surgery Association has voluntarily suspended macro-textured and polyurethane implants, in response to an urgent request from the Dutch health minister.

This ICIJ article also highlights new findings and developments on breast implant risks:

According to one forthcoming study, Silimed polyurethane textured implants pose a 23-times higher risk of ALCL, and Allergan Biocell textured implants pose a 16-times higher risk of ALCL, than lower surface area Siltex textured implants by Johnson & Johnson. Based on data from Australia and New Zealand, the study will appear in the May issue of the journal Plastic and Reconstructive Surgery.

This issue is evidently becoming increasingly troublesome in the United States and other countries around the world. As always, we will continue to monitor new information and developments in the BIA-ALCL literature, and to see if the U.S. may follow in the decision to ban textured implants.

March 2019 FDA Meeting On Breast Implants: A Summary Of What You Need To Know

 

Written by: Laura Beasley, Legal Assistant

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

 

It is likely that many of you, at this point, have heard about the issue of BIA-ALCL and may know someone who has had it.

 

Breast Implants and Rare Blood Cancer

BIA-ALCL is Breast Implant-Associated Anaplastic Large Cell Lymphoma. We have monitored this type of cancer and its relation to breast implants for quite some time now. You can refer to several of our past articles to learn more background on the subject matter. “2019 Discoveries and Warnings on Breast Implant-Associated Lymphoma” is our most recent article as regards general information. The longer we monitor this issue, the greater the concern about it becomes.

Due to the fact that this type of cosmetic surgery is the most popular one in the United States, hundreds of thousands of women undergo it. This means that hundreds of thousands of women are at risk, and many of them never warned.

Now that more diagnoses are popping up and the issue is being taken more seriously, the FDA decided that it is time to address this in front of the public. This is in efforts to ensure that women and medical doctors are warned and understand the risks, and to call out the manufacturing companies who have not been compliant. 

The article we published on March 22, 2019, "Lymphoma Cancer Associated With Breast Implants: FDA Advisory Committee Meeting March 2019" provides an outline as to the March 25-26, 2019 FDA CDRH General and Plastic Surgery Devices Advisory Committee Meeting.

 

FDA on the Issue

The FDA recently published an article in March 2019, “FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements” which informs that 2011 is when the FDA first acknowledged that there may be a link between breast implants and this type of cancer. However, it was extremely rare and there could be no conclusion as regards the relationship.

Now that the FDA is making formal public statements about the association, the risks are becoming more evident, which is something many women had not been aware of. 

The March 2019 FDA article makes the statement, “Breast implants are not lifetime devices and the longer a patient has the implants, the more likely they are to experience local complications and adverse outcomes requiring breast implant removal”

The amount of women who have been or are diagnosed with BIA-ALCL has risen significantly in the past few years.

 

Educating and Warning the Public while Calling out Manufacturers

As mentioned, days after the FDA issued the two warning letters, they conducted an advisory committee meeting in which they called out breast implant manufacturers such as Mentor Worldwide LLC in Irvine, California and Sientra, Inc. of Santa Barbara, for not conducting mandatory studies on post-op patient satisfaction. We get this information from the March 2019 FDA article:

Breast implant post-approval studies designed at the time of device premarket approval to follow patients longitudinally and answer our long-term questions have been unreliable. Poor compliance and changes in surgical practice over time have produced results difficult to interpret in a generalized manner much less with the precision needed to deliver personalized patient care.

These post-approval studies were supposed to follow-up with patients who were enrolled in the study. A specific number of patients to be enrolled was set by the FDA. The main issues arose in the facts that these companies simply did not have near the correct number of women in the studies as well as very low follow-up rates.

Additionally, the FDA meeting that took place included hearing from the companies that manufacture the legal, approved breast implants: Allergan, Mentor, Sientra, and IDEAL. It also heard from advocates who shared their personal experiences with this issue.

An article related to the subject from The Washington Post, “Women who say they were sickened by breast implants demand FDA action: ‘I was not warned.’,” stated:

Many of the advocates who spoke on Monday called for a ban on textured implants – the kind strongly linked to the cancer. There is some evidence the problem could be caused by bacterial infections involving the implants, researchers said.

As stated before, but emphasized now, we recommend that anyone thinking about undergoing such a procedure or already has, should speak with their medical doctor about the risks associated.

Visit our Breast Implants Lymphoma Cancer page on our website for more information.

2019 Discoveries and Warnings on Breast Implant-Associated Lymphoma

 

Written by: Laura Beasley, Legal Assistant

Law Offices of Thomas J. Lamb, P.A. 

 

We have previously published several articles regarding the association between breast implants and lymphoma cancer. On our law firm’s website, you can learn more about our current investigation of breast implant cases that involve lymphoma and blood cancers.

 

Background of Population at Risk

There continues to be an apparent correlation between breast implants and lymphoma cancer, referred to medically as Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA - ALCL). The number of reported cases is only rising, and it is important for women to realize what kind of implants are the most at-risk for causing this type of cancer.

CNN news recently published an article in February 2019, "FDA Reports Additional Cases of Cancer Linked to Breast Implants", which provides information as to how many women in the world are in this at-risk population. It notes that there are around 10-11 million women who have the implants.

The February 2019 CNN article confirms that these cases are seen mostly with textured implants rather than smooth ones. The article also notes that this cancer is treatable if detected early because its onset is slow.

The company Allergan, specifically, has textured breast implants which have been recently recalled in Europe due to their connection with BIA-ALCL. Read more about this health concern in Europe through our earlier article, "Breast Implants Recall: Allergan Textured Products in Europe Removed From Market December 2018"

Diagnoses and Lawsuits

To find more detailed information about the lawsuits which have been filed in the past, see our previous article, "Several 2018 Breast Implant Lymphoma Cancer Lawsuits Already Filed".  Currently, news companies are publishing articles with updated information about the association as well as the increase in women diagnosed. The February 2019 CNN news article states:

At least 457 women in the United States so far have been diagnosed with anaplastic large cell lymphoma, the Food and Drug Administration said in a statement Wednesday. Of those, nine have died as a result of the rare cancer, which affects cells in the immune system and can be found around the breast implant

The number of medical device reports regarding this issue received by the FDA is now at 660, showing a notable increase in the past year. Our recent February 2019 article, "Breast Implants Lymphoma Cancer Cases Update", provides a more detailed summary of this knowledge.  

 

Alerting Medical Doctors of Implant Risks

It is our understanding that the FDA is now sending letters to medical doctors, “urging them to learn about BIA - ALCL so they can better diagnose and treat women who may be at risk” (February 2019 NBC news article).

In addition, ALCL is now apparently a known risk with implants beyond breast implants. Medscape published an article, "Fatal Implant - Associated Lymphoma After Buttock Enhancement", which alerts physicians to the association between ALCL and textured silicone implants used in places other than breasts.

We encourage you to discuss with your doctor if you are planning on undergoing or have undergone an implant surgery to understand the potential risks.

Efforts to Advance MiraLAX Studies and Innovations to Inform the Population

 

Written by: Laura Beasley, Legal Assistant 
Law Offices of Thomas J. Lamb, P.A.

 

As the complications with the over-the-counter (OTC) drug MiraLAX remain present, we have continued to monitor any developments in the research that is being conducted.

Previously, the CHOP study had reportedly been “suspended indefinitely” without much public knowledge as to why or when it may resume. An earlier article of ours from January 2018, "MiraLAX Pediatric Study on Psychiatric Side Effects Projected to be Completed in 2018" goes into more depth of what this study is, and you can see the timeline of events which have occurred up until the delay.

 

FDA and Concerned Population Push for Advance in Study

Part of our continuous monitoring has been maintaining communication with parents and members of the community who have been affected by, or are involved with, this issue.

To reiterate, MiraLAX is an OTC drug which is used to help with occasional constipation. Polyethylene glycol (PEG) 3350 is the active ingredient which is the subject that the MiraLAX complications are in reference to. You can get more detailed information about these adverse reactions from our May 2017 article, "Growing Concern About Reports of Children Who Developed Neuro-Psychiatric Problems After Taking MiraLAX"

We understand that there has been communication involving the United States Food and Drug Administration (FDA), concerned parents and members of the community, and the United States Senator regarding the matter through legislative means.

 

Necessary Revision for Components of the Study

Within the CHOP study, there were to be two phases; the first being developing precise laboratory assays to measure several PEG 3350 metabolites. More information on PEG 3350 and the metabolites or "compounds" which it is comprised of can be found in our previous article from October 2018, "Inconclusiveness of MiraLAX Studies Leading to Frustration for Parents". The second phase is the main clinical study, where the goal is to see if there is noticeable amounts of the PEG 3350 or metabolites in the blood of children who take it for chronic constipation.

Apparently, the suspension of the CHOP study was due to developmental issues regarding the precise techniques for correct measurement of the PEG 3350 metabolites - in other words, the first phase of the study was not able to be completed, which suspended the second phase.

This recent communication involving the FDA emphasizes the cruciality of establishing the appropriate techniques for detecting and measuring PEG 3350 and the related metabolites, so that there are reliable and meaningful results during the main clinical phase. Expert scientists within the Office of Pharmaceutical Quality have been requested to assist with this process.

 

Innovations for Reaching Large Audience

Additionally, it is our understanding that there is an investigative podcast in the works which will interview parents and members of the community who are directly affected by this issue, as well as provide insight and updates on developments within the study of this drug. If you are familiar with podcasts, you can understand how sufficient this technique is for delivering information to a large audience with the ability to put out new information whenever desired. If you are not familiar with them, and you are curious to know more about the MiraLAX situation, this would be a great opportunity to hear from knowledgeable, involved people.

When the podcast becomes active, we will be sure to share information as to how to listen to it. Accordingly, if and when we are aware of any advancements in the CHOP study or new information for the MiraLAX situation in general, we will continue to keep our audience as informed as we are.  

Inconclusiveness of MiraLAX Studies Leading to Frustration for Parents

 

Written by: Laura Beasley, Legal Assistant 

Law Offices of Thomas J. Lamb, P.A. 

 

Background

Polyethylene Glycol (PEG) 3350, the active ingredient in MiraLAX, has increasingly become a serious concern for the parents of children who have been put on this drug. 

An earlier post of ours in May 2017, "Growing Concern About Reports Of Children Who Developed Neuro-Psychiatric Problems After Taking MiraLAX" introduced the issues with the PEG 3350 usage:

Despite the fact that MiraLAX is not intended for use by young children, pediatricians and other doctors have been prescribing or recommending MiraLAX use in that patient population for many years, apparently. Generally, this use of MiraLAX by children pursuant to their doctor's guidance is called "off-label" use.

What has reportedly happened to these children (according to their parents) as a result of this long-term usage of PEG 3350, is extreme neuro-psychiatric effects such as: depression, anger, anxiety, paranoia, and mood swings.

In January 2018, our post, "MiraLax Pediatric Study on Psychiatric Side Effects Projected to be Completed in 2018" gives detailed information regarding a citizens' petition to investigate the drug's safety as well as the FDA's response. This includes information about the well-known CHOP study that was supposed to be completed by the end of 2018 and has apparently been suspended indefinitely.

 

A New Study on PEG 3350 Safety

We now have knowledge of a new study that has taken place in efforts to resolve the continuing concerns of long-term PEG 3350 use in children.  On October 4, 2018, Gastroenterology & Endoscopy News published an article, "New Study Tries to Address PEG 3350 Safety Concerns"  [registration required - free], which provides a comprehensive summary of the study.

The study included administering a small amount of PEG 3350 (17 g) with tap water to the children and then monitoring their blood samples over a period of 3 hours compared to that of similar children who did not take the drug.

Diethylene glycol, ethylene glycol, and triethylene glycol - compounds which are neurotoxic at high concentrations - were found normally present in all of the participants.  From this, they came to the conclusion that using PEG 3350 for long periods of time does not create a hazardous increase in these compounds and therefore, is safe.

 

Concerns Continue

Though this new study sought to ease the minds of worrying parents, thousands are displeased with the results and, in fact, are left seeking even more information than before.

First-hand accounts from parents denounce the realities of this study.  The article, "New Study Tries to Address PEG 3350 Safety Concerns" [registration required - free],  shows that even the authors of the study acknowledge this lack of congruity:

Despite these findings, the researchers acknowledged that "limitations of this study prevent affirming that PEG 3350 does not cause neuropsychiatric events."  These limitations included the small sample size, potential variation in susceptibility to PEG 3350–related compounds, and exclusion of children with compromised mucosal barrier function.

We are aware that these inconclusive studies are creating a population of frustrated, information-seeking parents.  That being said, our analysis of this possible drug-safety problem is ongoing and we remain open to any new or relevant information parents and medical researchers may have.   

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Esmya and Risk of Serious Liver Injury: UK Drug Regulator Issues Safety Alert in August 2018

 

In early August 2018 the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued an alert to healthcare professionals concerning the risk of serious liver damage from Esmya (ulipristal acetate).

This August 2018 MHRA Esmya alert also provided information about new measures intended to minimize the risk of serious liver damage. These Esmya prescribing restrictions and requirements replace the temporary safety measures introduced in February 2018.

In the US, the FDA has declined to approve Esmya as a treatment for abnormal uterine bleeding in women with uterine fibroids. Instead, the FDA is requesting more information about drug safety issues.

• MHRA Alert re: Esmya and Risk of Serious Liver Injury

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