Drug Safety Developments

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.   

Drug Injury Watch: Side Effects News & Reports

Drug Injury Law: Medical & Legal Information

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

Drug Injury Watch: Side Effects News & Reports

Drug Injury Law: Medical & Legal Information

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

 

Drug Injury Watch: Side Effects News & Reports

Drug Injury Law: Medical & Legal Information

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
  
  

 
Drug Injury Watch: Side Effects News & Reports

Drug Injury Law: Medical & Legal Information

 

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.

 

 

Drug Injury Watch: Side Effects News & Reports

Drug Injury Law: Medical & Legal Information

 

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

---

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.

 

 

 

Drug Injury Watch: Side Effects News & Reports

Drug Injury Law: Medical & Legal Information