Drug Safety Developments

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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FDA Provides Updated Number of Breast Implants Lymphoma Cancers

 

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

 

About BIA-ALCL

The U.S. Food and Drug Administration (FDA) has been aware of the possible connection between breast implants and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) since 2011. 

This condition is a rare type of non-Hodgkin’s lymphoma, which is a cancer of the immune system, rather than a cancer of the breast tissue.  It occurs in the scar tissue and the fluid surrounding the implant within the breast capsule, but can also spread throughout the body. 

The most recent data available suggests that BIA-ALCL most often occurs among patients with textured breast implants, as the surface of the implant provides space for bacteria to attach and proliferate.      

 

FDA Reports

On March 21 2017, the FDA reported that the exact number of cases of BIA-ALCL has been difficult to determine "due to significant limitations in world-wide reporting and lack of global implant sales data." 

Despite the limitations, the FDA released updated information on the number of reported cases earlier today.  In this March 2018 news report, they state the following:

As of September 30, 2017, the FDA had received a total of 414 medical device reports (MDRs) of BIA-ALCL, including the death of nine patients.

272 of the 414 reports included information on the surface information of the implant at the time of the report, including 242 with textured surfaces and 30 with smooth surfaces...In the MDR reports, half of the reported cases were diagnosed within 7-8 years of implantation.

This data was last updated in September 2017.  

 

Ongoing Investigation

In the report released earlier today, the FDA provided the following information on their efforts:

[W]e are working to update and enhance the information we have on this association, including updating the total number of known cases of BIA-ALCL and the lifetime risk of developing BIA-ALCL as reported in medical literature.

We hope that this information prompts providers and patients to have important, informed conversations about breast implants and the risk of BIA-ALCL.  At the same time, we remain committed to working in partnership with all stakeholders to continue to study, understand and provide updates about this important public health issue.

Going forward, we will continue to monitor the medical and regulatory information for updates on the number of reported BIA-ALCL cases and the condition's association with breast implants.

In the meantime, we encourage you to visit our website for more information and submit a free case evaluation if you or someone you know has been diagnosed with BIA-ALCL.

 

Breast Implants: Lymphoma / Blood Cancer Cases Overview

Free Breast Implants Case Evaluation

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Previous articles on this topic:

• 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:

• 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

Gout Medicine Uloric May Require Recall or Increased Warnings of Cardiac Death

 

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

 

About Uloric

Uloric (febuxostat) is indicated for the chronic management of hyperuricemia in patients with gout.  Gout is a form of arthritis, and occurs when uric acid in the body builds up and causes sudden attacks of redness, swelling, and pain in one or more joints.  

Uloric is considered a xanthine oxidase (XO) inhibitor, and eases gout symptoms by lowering uric acid levels in the blood.

 

Prior Warnings

When Uloric was approved by the US Food and Drug Administration (FDA) in 2009, its manufacturer, Takeda Pharmaceuticals, was required to conduct a safety study.  The study was titled "Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout and Cardiovascular Comorbidities" (CARES).  This trial recently concluded, but the FDA has yet to complete their comprehensive review of the study results.

On November 15 2017, the FDA issued a drug safety communication concerning Uloric based on the preliminary findings of the study.  In this document, they warned of an increased risk of heart-related death with Uloric compared to other gout medications that contain allopurinol.

In addition, they provide the following information:

The primary outcome was a combination of heart-related death, non-deadly heart attack, non-deadly stroke, and a condition of inadequate blood supply to the heart requiring urgent surgery. The preliminary results show that overall, febuxostat did not increase the risk of these combined events compared to allopurinol. However, when the outcomes were evaluated separately, febuxostat showed an increased risk of heart-related deaths and death from all causes.

At this stage, the mechanism of harm is not clearly understood.  Otherwise put, researchers are unsure how exactly Uloric is causing death in patients who use it.

__________________________________________________________________

Uloric

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Strictly Confidential, No Obligation.

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Drug Label

The current drug label for Uloric warns that when compared to similar gout drugs that contain allopurinol, Uloric has a higher rate of cardiovascular thromboembolic events such as cardiovascular deaths, non-fatal myocardial infarctions, and non-fatal strokes.  However, they are quick to point out that no causal relationship has yet been established. 

Going forward, the FDA is considering adding increased warnings to the drug label for Uloric in order to more adequately convey the risk of cardiac-related deaths.  According to a recent MedScape article, "Options include a new warning in the labeling in addition to the one already there, or pulling [Uloric (febuxostat)] from the market."  The article also mentions several doctors who are not in favor of removing Uloric from the market, given its advantages over allopurinol in certain populations.

We will continue to monitor the medical and regulatory literature for more information on the association between Uloric and fatal cardiovascular events, and report on significant developments.

 

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