Drug Safety Developments

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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Invokana / Jardiance / Farxiga: Increased Risk Of Pancreatitis, According To Health Canada Safety Review

 

Health Canada's safety review of sodium-glucose cotransporter-2 (SGLT2) inhibitors -- e.g., Invokana (canagliflozin), Farxiga (dapagliflozin), and Jardiance (empagliflozin) -- concluded in July 2018 with the finding that there may be a link between the use of SGLT2 inhibitors and acute pancreatitis. However there was limited evidence to suggest a link with chronic pancreatitis. Health Canada is working with the manufacturers to update the Canadian product monographs, or drug labels, for SGLT2 inhibitors to include this increased risk of pancreatitis.

 

• Summary of Safety Review by Health Canada

 

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Esmya: FDA Does Not Approve This New Drug For Abnormal Uterine Bleeding Due To Safety Concerns

 

On August 21, 2018 the drug company Allergan Plc announced that the FDA has declined to approve Esmya, its treatment for abnormal uterine bleeding in women with uterine fibroids.

Instead, the FDA is requesting more information about drug safety issues concerning Esmya, which has been approved for use in Europe.

Notably, earlier this year European drug regulators put restrictions on the use of Esmya while they investigate reports that Esmya is linked to serious liver damage.

We have covered that Esmya drug safety issue previously in this February 2018 article, "Uterine Fibroid Drug Esmya Investigated Due to Severe Liver Injuries".

 

• Original News Report
  
  

 
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Settlements Reached for First Round of Abilify Gambling Lawsuits

 

Written by: Heather Helmendach, Legal Assistant 
Law Offices of Thomas J. Lamb, P.A.

 

Background

In May 2016, the U.S. Food and Drug Administration (FDA) released a Drug Safety Communication concerning the antipsychotic drugs, Abilify, Abilify Maintena, and Aristada.

This safety announcement provided the following warning:

The U.S. Food and Drug Administration (FDA) is warning that compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex have been reported with the use of the antipsychotic drug aripiprazole (Abilify, Abilify Maintena, Aristada, and generics). These uncontrollable urges were reported to have stopped when the medicine was discontinued or the dose was reduced. These impulse-control problems are rare, but they may result in harm to the patient and others if not recognized.

Although pathological gambling is listed as a reported side effect in the current aripiprazole drug labels, this description does not entirely reflect the nature of the impulse-control risk that we identified. In addition, we have become aware of other compulsive behaviors associated with aripiprazole, such as compulsive eating, shopping, and sexual actions. These compulsive behaviors can affect anyone who is taking the medicine. As a result, we are adding new warnings about all of these compulsive behaviors to the drug labels and the patient Medication Guides for all aripiprazole products.

 

Lawsuits

Since the FDA's warning, over 800 Abilify lawsuits have been filed against the drug manufacturers, Bristol-Myers Squibb and Otsuka Pharmaceuticals.  These cases involve Plaintiffs who used Abilify, then experienced the harmful compulsory behaviors that the FDA warned about in May 2016. 

The Plaintiffs argue that the manufacturers of Abilify, Abilify Maintena, and Aristada should have known and warned about the link between their drugs and the harmful, uncontrollable urges.  If such warnings had been provided by the drug manufacturers, then the Plaintiffs claim that they would have recognized the causes of such urges and been able to seek medical help before undergoing such devastating losses.

These Abilify cases have been consolidated in the multidistrict litigation (MDL) in the Northern District of Florida.  An MDL is often created in order to centralize cases that involve the same defendants and issues.

Three test cases out of this MDL were selected by the involved parties and the judge presiding over the MDL to go to trial in June of this year.  However, these cases were recently settled after a successful mediation.  According to the Order signed by the MDL judge, once the settlement money is paid by the Defendants and dismissals are signed by the Plaintiffs, the cases will officially be taken off the trial docket.

 

Going Forward

Often times, the test cases in an MDL -- often referred to as "bellwether trials" -- will determine rulings for the remaining cases in the MDL.  Given that the original cases never went to trial, a new round of test cases will be selected.  If the second round of cases is again settled before going to trial, one could predict that the cases remaining in the MDL could also anticipate settlements instead of trial dates.

We will continue to monitor the legal news for updates on the Abilify gambling lawsuits and report significant developments as we are made aware of them.

 

 

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Several 2018 Breast Implant Lymphoma Cancer Lawsuits Already Filed

 

Written by: Heather Helmendach, Legal Assistant 
Law Offices of Thomas J. Lamb, P. A.

 

Background

Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is a type of non-Hodgkin's lymphoma, which is a cancer of the cells of the immune system.  This rare T-cell lymphoma can develop as a result of breast implants, though the mechanism of injury is not fully understood at this time.  However, based on current data from the U.S. Food and Drug Administration (FDA), we do know that textured breast implants carry a greater risk of BIA-ALCL than smooth implants.

According to the most recent BIA-ALCL update from the FDA, 414 medical device reports (MDRs) related to breast implants and ALCL have been filed.  Nine of these reports involved the death of the patient.

As more information concerning the risks of BIA-ALCL becomes available, medical and regulatory agencies expect the number of these breast implant lymphoma diagnoses to continue to rise.

 

Recent Lawsuits

Several lawsuits have already been filed this year on behalf of women who have been diagnosed with BIA-ALCL as a result of their breast implants.

In March of 2018, a woman filed suit against Allergan Inc. because of the BIA-ALCL diagnosis she received.  The Plaintiff had her "Allergan Natrelle Silicone" breast implants for less than two years before her diagnosis.  Her treatment consisted of several revision and removal surgeries, then eventually chemotherapy and removal of her affected lymph nodes.

According to the Complaint, the "Plaintiff maintains that Defendants' breast implants lacked proper warnings as to the dangers associated with their use."  The lawsuit also alleges that the manufacturer of the breast implants failed to promptly and properly report the results of post-marketing studies that were required by the FDA. 

A woman from Ohio alleges the same in her lawsuit against Mentor Worldwide, which was filed last month (April 2018) in New Jersey.  The Plaintiff in this case had the Mentor MemoryGel SILTEX breast implants for approximately eight years before her BIA-ALCL diagnosis.  As a result of her diagnosis, she required removal of the implants and six of her lymph nodes, as well as chemotherapy.

 

Going Forward

We expect to see additional lawsuits filed by women who have received BIA-ALCL diagnoses as the numbers of affected women increase steadily. 

To learn more about BIA-ALCL lawsuits, we encourage you to visit our website and our resources page.

If you--or someone you know--have been diagnosed with BIA-ALCL or some other lymphoma cancer as a result of breast implants, we encourage you to complete our free case evaluation.

Of course, we will continue to monitor the medical, regulatory, and legal news for updates concerning BIA-ALCL.

 

 

Breast Implants: Lymphoma / Blood Cancer Cases Overview

Free Breast Implants Case Evaluation

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Previous articles on this topic:

• FDA Provides Updated Number of Breast Implants Lymphoma Cancers
• New Data Released on Risk of Lymphoma Due to Breast Implants
• Breast Implant-Associated Lymphoma Diagnoses on the Rise
• What is the Risk of Death Due to Breast Implant-Associated Lymphoma?
• Breast Implants and Lymphoma: Who's to Blame?
• Breast Implant Lymphoma: Causes Uncertain, but Costs Undeniable
• Breast Implants Linked to Rare Lymphoma Blood Cancer

Breast Implants: Lymphoma / Blood Cancer Cases Overview

Free Breast Implants Case Evaluation

---

Previous articles on this topic:

• FDA Provides Updated Number of Breast Implants Lymphoma Cancers
• New Data Released on Risk of Lymphoma Due to Breast Implants
• Breast Implant-Associated Lymphoma Diagnoses on the Rise
• What is the Risk of Death Due to Breast Implant-Associated Lymphoma?
• Breast Implants and Lymphoma: Who's to Blame?
• Breast Implant Lymphoma: Causes Uncertain, but Costs Undeniable
• Breast Implants Linked to Rare Lymphoma Blood Cancer

Do the Risks Outweigh the Benefits of DPP-4 Inhibitors Diabetes Drugs?

 

Written by: Heather Helmendach, Legal Assistant 
Law Offices of Thomas J. Lamb, P. A.

 

DPP-4 Diabetes Drugs

One of the popular classes of drugs for type 2 diabetes consists of dipeptidyl peptidase-4 (DPP-4) inhibitors.

This DPP-4 inhibitors class comprises the following drugs:

• Onglyza
• Kombiglyze XR
• Nesina
• Kazano
• Oseni
• Glyxambi
• Janumet (XR)
• Januvia
• Jentadueto
• Tradjenta
• Qtern

Based on various studies and patient reports, these drugs have been associated with the following side effects:

• Heart Failure
• Kidney Failure / Renal Failure
• Kidney Problems
• Decreased Renal Function 
• Cerebral Infarction / CVA / Stroke
• Myocardial Infarction (MI) / Heart Attack
• Acute Pancreatitis
• Severe Joint
• Inflammatory Bowel Disease (IBD)
• Ulcerative Colitis
• Crohn's Disease
• Rhabdomyolysis

 

Risk/Benefit Analysis

In my last article, I discussed the findings of a recent study conducted on three types of diabetes drugs: sodium-glucose cotransporter (SGLT-2) inhibitors, dipeptidyl peptidase (DPP-4) inhibitors, and incretin mimetics--also referred to as glucagon-like peptide (GLP-1) agonists.

Researchers found that all three classes of drugs were effective in lowering blood sugar levels among type 2 diabetes patients.  However, only two of the classes of diabetes drugs--SGLT-2 inhibitors and incretin mimetics--were shown to reduce the risk of death.  Furthermore, DPP-4 inhibitors were no more effective at reducing the risk than a placebo or no treatment at all.

This finding is particularly alarming given that type 2 diabetes is associated with higher risk of death due to heart attacks or strokes. 

In light of this information about the risks of DPP-4 diabetes drugs, one must wonder if other classes of type 2 diabetes drugs--which help reduce the risk of death--would be a better alternative.  Otherwise put, taking DPP-4 diabetes drugs may not be worth the risks that accompany them.

 

Current Lawsuits

In April 2016, the FDA issued a Drug Safety Communication that warned of the increased risk of heart failure in patients taking Onglyza, Kombiglyze XR, Nesina, Kazano, and Oseni.

Following that announcement, almost one hundred lawsuits were filed on behalf of patients taking Onglyza and Kombiglyze XR.  These cases have been compiled in a multi-district litigation (MDL) in Kentucky and are currently pending.

If you, or someone you know, have experienced any of the aforementioned side effects as a result of taking a DPP-4 inhibitor diabetes drug, we encourage you to visit our website for more information and complete a free case evaluation.

 

 

 

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Only Two out of Three Classes of Diabetes Drugs Help Reduce the Risk of Death

 

Written by: Heather Helmendach, Legal Assistant 
Law Offices of Thomas J. Lamb, P. A.

 

Class Comparisons

Three popular types of diabetes drugs include sodium-glucose cotransporter (SGLT-2) inhibitors, dipeptidyl peptidase (DPP-4) inhibitors, and incretin mimetics (also referred to as glucagon-like peptide (GLP-1) agonists).

The following table provides a list of some of these types of drugs:

SGLT-2 Inhibitors	SGLT-2 / DPP-4 Inhibitors	DPP-4 Inhibitors / Incretin Mimetics	Incretin Mimetics
Invokana	Glyxambi	Onglyza	Byetta
Invokamet (XR)	Qtern	Januvia	Bydureon
Farxiga		Janumet (XR)	Victoza
Xigduo XR		Kazano	Juvisync
Jardiance		Oseni
Synjardy (XR)		Tradjenta
Steglatro		Jentadueto
Steglujan		Nesina
Segluromet		Kombiglyze XR

 

Study Results

A recent study compared these three types of diabetes drugs in order to determine their effect on "all-cause mortality" in patients with type 2 diabetes.  While all three classes lowered blood sugar levels, only two reduced the risk of death.  

The researchers found the use of SGLT-2 inhibitors and incretin mimetics was associated with lower mortality rates than DPP-4 inhibitors.  More specifically, SGLT-2 inhibitors were associated with a 21% reduction in cardiovascular-related death, and incretin mimetics were associated with a 15% reduction.

However, DPP-4 inhibitors did not reduce the risk of death when compared to a placebo or no treatment at all.

One of the researchers acknowledged that further studies are needed to confirm their findings, and tracking participants for a longer period of time would be beneficial.

 

Side Effects

While the study did not aim to identify any particular harmful side effects directly caused by the drugs, numerous side effects have been associated with these classes of drugs in other studies.  As such, one must wonder how the benefits of these drugs weigh against their potentially-fatal side effects.

For example, users of SGLT-2 inhibitors have experienced the following side effects:

• Diabetic Ketoacidosis (DKA)
• Ketoacidosis
• Ketosis
• Leg Amputation
• Foot or Toe(s) Amputation
• Acute Kidney Injury

• Kidney Failure / Renal Failure
• Kidney Damage
• Pyelonephritis (kidney infection)
• Urosepsis (blood infection)
• Urinary Tract Infection (UTI)
• Bladder Cancer

As for DPP-4 inhibitors, these side effects have been observed:

• Heart Failure
• Kidney Failure / Renal Failure
• Kidney Problems
• Decreased Renal Function 
• Cerebral Infarction / CVA / Stroke
• Myocardial Infarction (MI) / Heart Attack

• Acute Pancreatitis
• Severe Joint Pain
• Inflammatory Bowel Disease (IBD)
• Ulcerative Colitis
• Crohn's Disease
• Rhabdomyolysis

Lastly, incretin mimetics carry a potential risk of pancreatic cancer.

Going forward, we will continue to monitor the medical literature concerning the side effects associated with these three classes of diabetes drugs.

In the meantime, we encourage you to fill out one of our free case evaluations concerning SGLT-2 inhibitors, DPP-4 inhibitors, and incretin mimetics.

 

 

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FDA Restricts Sales of Essure Permanent Birth Control Device

 

Written by: Heather Helmendach, Legal Assistant 
Law Offices of Thomas J. Lamb, P. A.

 

Background

Essure is a form of permanent birth control that requires the implantation of a small device within the female reproductive system.  It was originally approved by the FDA in 2002, and approximately 750,000 women worldwide have received Essure since its approval.  Given that the device is meant to be permanent, it is not typically removed unless necessitated by complications.

Bayer is the manufacturer of this contraceptive device, and has received pressure from the U.S. Food and Drug Administration to increase warnings for Essure in light of the increasing number of adverse event reports that have been submitted within the past several years.

 

Previous Warnings

On November 15, 2016, the FDA approved a revised label for Essure that included a boxed warning and a Patient Decision Checklist (p. 19 of linked document).  A boxed warning, sometimes called a "Black Box Warning" is the most serious warning that can be included with a product.  

This new Essure warning reads:

WARNING: Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required. This information should be shared with patients considering sterilization with the Essure System of Permanent Birth Control during discussion of the benefits and risks of the device. [Emphasis added]

By adding this warning and including the checklist, the FDA hoped to ensure that women were adequately informed of the possible risks of undergoing implantation of this medical device.  However, they recently determined that some women are still not being thoroughly informed of the risks, and decided further action was necessary.

 

New Requirements

On April 9, 2018, the FDA restricted the sale of Essure, and sent a letter to Bayer requiring them to make further changes to the current label for this contraceptive device.

Per the new FDA requirements, women must now read and sign a brochure that provides detailed information on the risks of Essure before they can undergo the implantation procedure.

Furthermore, sale and distribution of Essure is limited to healthcare providers who agree to review the “Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement” with patients.  Both the patient and their doctor must also sign the checklist before the Essure implantation procedure can take place.

Given that Essure sales dropped 70% after increased warnings were required by the FDA in 2016, and Bayer stopped selling Essure outside of the U.S. last year for "commercial reasons," it will be interesting to see if the product will vanish from U.S. markets in the wake of these new warnings and requirements.

We will continue to monitor the medical literature for updated information on Essure and its associated risks, and report on significant developments.

In the meantime, we encourage you to complete a Free Essure Case Evaluation if you or someone you know has experienced severe complications as a result of the Essure permanent contraceptive device.

 

 

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