Drug Safety Developments

SGLT2 Inhibitors May Have an Increased Risk of Acute Renal Failure

 

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

 

SGLT2 Inhibitors: A New Side Effect 

In previous articles, I have discussed SGLT2 inhibitor diabetes drugs such as Invokana, Farxiga, and Jardiance and the adverse events associated with them.  Such side effects include diabetic ketoacidosis (DKA) and lower-limb amputations.

A recent study identified a new possible side effect of these drugs through an analysis of the FDA Adverse Event Report System database (FAERS).  The researchers found that SGLT2 inhibitors were associated with an increased risk of acute renal failure.

Acute Renal Failure: The Statistics

According to the study, out of the 1,224 reported cases of acute renal failure that involved SGLT2 inhibitors, the drugs were defined as the "primary" or "secondary" causes of acute renal failure in 96.8% of the cases.

Furthermore, the number of acute renal failure reports for these drugs was significantly greater than those involving patients with Type 2 diabetes who were not treated with SGLT2 inhibitors.

Interpreting Results

Researcher Amichai Perlman, PharmD provides her input on the study's findings:

Our results should be interpreted with caution as this is an observational study with limited control of potential confounding factors...However, we believe that clinicians should consider simple measures to minimize this potential risk, including instructing patients to keep hydrated and avoid volume depletion; consider closer monitoring of kidney function in patients with concomitant ACE inhibitors and diuretics, especially in patients with impaired baseline renal function; and avoiding administration of SGLT2 inhibitors with nephrotoxic agents, such as NSAIDs, as well as to consider temporary withholding of SGLT2 inhibitors prior to radio-contrast studies.

We are currently investigating possible drug injury lawsuits concerning Type 2 diabetes patients who have been diagnosed with acute renal failure, DKA, or lower-limb amputations as a result of their use of SGLT2 inhibitors such as Invokana, Farxiga, or Jardiance.

For more information, please visit our website and complete a free case evaluation.

 

Drug Injury Watch: Side Effects News & Reports

Drug Injury Law: Medical & Legal Information

 

Study Suggests HCV Clearance with DAAs Lowers the Risk of Liver Cancer

 

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

 

Background

Hepatitis C virus (HCV) treatment drugs--such as Harvoni, Sovaldi, Viekira Pak, and Technivie--are classified as Direct Acting Antiviral Agents (DAAs).

The relationship between DAA treatment and liver cancer, or hepatocellular carcinoma (HCC), is a complex one that has been the subject of several studies in the past year.

While some studies found an increased risk of liver cancer in those who used DAAs, others found insufficient evidence for such a link, or even evidence that showed a reduced risk with DAA use.

Norah Terrault, MD, of the University of California San Francisco addresses the earlier studies on the topic in an article by Medpage Today published October 23, 2017:

Terrault said the apparent increase in HCC risk was probably seen because the physicians were treating sicker patients with the DAAs, patients who would not have been eligible for the more toxic and arduous earlier regimens.

 

New Research

The most recent study on the topic was published in Gastroenterology earlier this month, and examined new cases of liver cancer in HCV patients, rather than recurring cases.  Information on the study can be found in the following press release: "Direct‐Acting Antiviral Medications Cuts Risk of Liver Cancer by 71%."

This study was based on the largest number of patients to date.  It examined over 62,051 patients in the VA healthcare system from 1999 to 2015.  Among those patients, 21,948 received DAA treatment alone, as opposed to interferon treatment or a combination of the two types of treatment.

As indicated by the title, the researchers in the study found that there was a 71% reduction in the risk of liver cancer among patients who achieved sustained virological response (SVR).  Otherwise put, among those who are cured of HCV--by DAA treatment, or otherwise--the risk of being diagnosed with liver cancer decreases by 71%.

 

The Fine Print

George N. Ioannou, MD, MS, of the University of Washington School of Medicine, Seattle, provides an interesting caveat to this statistic:

However, patients with hepatitis C may already have developed cirrhosis or advanced fibrosis before the hepatitis C is eradicated, which may put them at risk of liver cancer even after hepatitis C is eradicated.

Furthermore, those who achieved SVR had a lower risk of liver cancer in general, regardless of the method.  This suggests that DAA treatment alone is not to be lauded for the reduced risk.

Additionally, the risk reduction percentages change among patients with cirrhosis; only a 50% risk reduction was observed in these patients.

Finally, the researchers in the study note that their findings may not be sufficient to establish a causal relationship between HCV cure and reduced risk of liver cancer.

Another point of interest is that Dr. Ioannou disclosed a relationship with Janssen, the manufacturer of Olysio, a DAA.  Dr. Terrault, though not directly involved in the study, also disclosed relationships with Abbvie, Gilead, Bristol-Myers Squibb, and Merk, all of whom manufacturer DAAs.

Please know that our law firm is NOT currently handling cases involving liver cancer and DAA treatment.  However, we will continue to monitor the medical literature on the topic and report significant new developments.

 

Drug Injury Watch: Side Effects News & Reports

Drug Injury Law: Medical & Legal Information

 

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Previous articles on this topic:

• August Update: Possible Link Between Hepatitis C Drugs & Liver Cancer
• July 2017 Update: Any Link Between Hepatitis C Drugs and Liver Cancer?
• No Link Seen Between Sovaldi Or Harvoni And Liver Cancer Recurrence
• Can Hepatitis C Drugs Harvoni Or Sovaldi Cause Return Of Liver Cancer?
• Is The Risk Of Liver Cancer Increased From Use Of Harvoni Or Sovaldi?

Nuedexta Drug Manufacturer Investigated by Los Angeles City Attorney

 

Update:  "Study Raises Questions on Nuedexta Prescribing"

Dextromethorphan-quinidine (Nuedexta), approved by the FDA for pseudobulbar affect based on studies in patients with amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS), appeared to be prescribed primarily for patients with other underlying disorders, an analysis of insurance records found.

Few patients who received the drug had a diagnosis of MS (8.4%) or ALS (6.8%); most (57%) had a diagnosis of dementia or Parkinson's disease, reported Aaron Kesselheim, MD, JD, MPH, of Brigham and Women's Hospital in Boston, and co-authors in JAMA Internal Medicine.

"Our study identified that this medication is primarily prescribed to patients with dementia or Parkinson's disease. This is concerning, since very few studies have evaluated the effectiveness or safety in this patient population," said lead author Michael Fralick, MD, of the University of Toronto....

After FDA approval, drugmaker Avanir Pharmaceuticals rolled out extensive ad campaigns, including television commercials featuring actor Danny Glover to generate awareness of pseudobulbar affect and subsequent ads calling on consumers to ask their doctor about possible treatment.

[Read article in full at original source]

(1/8/19)

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

 

Los Angeles City Attorney Mike Feuer has launched an investigation into the drug manufacturer of Nuedexta, Avanir Pharmaceuticals, in response to the information his office has received regarding improper and potentially illegal activity concerning the sales, prescription, and administration of Nuedexta.

Nuedexta is approved by the FDA to treat pseudobulbar affect (PBA), which is a rare condition that involves uncontrollable laughing and/or crying.  

However, Nuedexta is not indicated for the treatment of dementia or Alzheimer's, even though it is being prescribed in ever-increasing numbers to elderly patients in nursing homes with these conditions.  Some have argued that the drug is being improperly prescribed simply to control agitated patients, in spite of the dearth of information on the effects of the drug among the elderly. 

Use of Nuedexta has also been shown to have serious medical consequences among those taking the drug, such as hemorrhages, cerebrovascular events, seizures, and even death.  More information on this topic can be found in my previous article, "CNN Investigates Over-Prescription of Nuedexta in Nursing Homes."

The City Attorney's Office has reason to believe that Avanir may be in violation of state and federal laws given their questionable sales and marketing tactics for Nuedexta.  For example, Avanir has allegedly given tens of thousands of dollars to some doctors in order to motivate them to promote the drug. 

In addition to Avanir, nursing homes where Nuedexta is often prescribed may also be subjected to investigation by the Los Angeles City Attorney's Office.

A recent article by CNN titled, "City of Los Angeles opens investigation into drugmaker following CNN report," provides the following additional information:

The City Attorney's Office said it is seeking information from family members of those given the drug, former and current Avanir employees, nursing home workers and anyone else with information about Nuedexta or Avanir.

Those interested can call the office's tip line (213-978-8371) or provide information online.

We will continue to watch for the release of additional information on this topic and report on significant developments as we become aware of them.

 

Drug Injury Watch: Side Effects News & Reports

Drug Injury Law: Medical & Legal Information

Breast Implant-Associated Lymphoma Diagnoses on the Rise

 

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

 

On October 18, 2017, the JAMA Surgery journal published an article titled "Breast Implant–Associated Anaplastic Large Cell Lymphoma A Systematic Review," in which they discuss the rate of occurrence of the condition.

The article served as a review of 115 articles on the topic of breast implant–associated anaplastic large cell lymphoma (BIA-ALCL) and 95 patients.

As explained in my previous articles (listed at the bottom of this page), BIA-ALCL is a rare non-Hodgkin lymphoma of T-cell origin that is typically found in the effusion fluid (seroma) surrounding the breast implant, or contained within the fibrous scar capsule.  Though this condition is not frequently diagnosed, the consequences can be fatal if left untreated.  

According to the JAMA article, diagnoses of BIA-ALCL are increasing as doctors and patients learn more about the condition.  While the condition is certainly rare, this new data suggests that it may not be as rare as it was initially thought to be:

The exact incidence is unknown due to the lack of standardized criteria for diagnosis; however, it is estimated to be 1 case per 30 000 women with implants per year, with a median time to onset after implantation of 10.7 years. A prospective study on Natrelle (Allergan) 410 breast implant risk factor analysis found that 4 patients of 17 656 who received breast implants developed BIA-ALCL, suggesting that the incidence may actually be closer to 1 case per 4000 [citations omitted]. 

However, many practitioners are still unaware of--or at least unfamiliar with--many important factors of BIA-ALCL.  In order to address this lack of knowledge, more information on the risks, symptoms, development, diagnosis, and treatment of BIA-ALCL is being distributed to the appropriate healthcare providers as it is published.

The JAMA article closes with the following call to action for surgeons and patients:

Before breast augmentation or reconstruction, surgeons need to convey the risk of breast implant–associated anaplastic large cell lymphoma to patients, with particular emphasis on the established linkage to textured implants; patients must be educated on the importance of routine surveillance after implantation, and it is likely that increased follow-up will lead to a further rise in this diagnosis.

Given increased access to necessary information on BIA-ALCL, the hope is that doctors will be better equipped to diagnose and successfully treat women exhibiting symptoms of the condition.

If you or someone you know have been diagnosed with BIA-ALCL, we encourage you to visit our website for more information, and complete a free case evaluation.

We will continue to monitor the medical literature concerning breast implants and this rare type of lymphoma, and report on new information as it becomes available.

 

Breast Implants: Lymphoma / Blood Cancer Cases Overview

Free Breast Implants Case Evaluation

 

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Previous articles on this topic:

• 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

CNN Investigates Over-Prescription of Nuedexta in Nursing Homes

 

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

 

Late last week, CNN reported on the possible inappropriate prescribing of the drug Nuedexta in nursing homes in their article, "The little red pill being pushed on the elderly."

Nuedexta is indicated for the treatment of pseudobulbar affect (PBA), a disorder estimated to affect less than 1% of all Americans.

DailyMed provides the following information on this condition in the "Indications and Usage" section for Nuedexta:

PBA occurs secondary to a variety of otherwise unrelated neurologic conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of proportion or incongruent to the underlying emotional state. PBA is a specific condition, distinct from other types of emotional lability that may occur in patients with neurological disease or injury.

Despite the rarity of this condition, Nuedexta is being prescribed to the elderly--particularly those in long-term care facilities--at an alarmingly high rate.  This is partially due to the fact that the drug has been frequently prescribed "off-label" as a means to control agitated or aggressive elderly patients with dementia.

The possibility of nefarious motives behind these frequent (and ever increasing) prescriptions was raised in CNN's article, and in some cases, proven.  Unsurprisingly, most, if not all, of these motives were rooted in the pharmaceutical company's desire to increase their profits.

Another distressing issue with the large number of Nuedexta prescriptions is the lack of extensive study concerning its effects in elderly patients.  Only one such study has been conducted, and the results showed an increased risk of falling among patients with Alzheimer's who were taking the drug, specifically twice that of those taking a placebo.

In addition, the recently-released FDA Adverse Events Reporting System (FAERS) Public Dashboard shows almost 300 reports concerning adverse effects classified as "serious," meaning they resulted in either hospitalization or death. 

Here is a list of some of the adverse events reported in patients using Nuedexta so far:

• Death
• Hemorrhages
• Cerebrovascular events
• Seizures

However, it is important to note that these adverse event reports do not necessarily mean that Nuedexta has been determined to be the cause of the reported harm.

If you or a loved one are taking Nuedexta and have experienced an adverse side effect that you believe was caused by the drug, please tell us about it in the "Comments" section, below.

 

Drug Injury Watch: Side Effects News & Reports

Drug Injury Law: Medical & Legal Information

What is the Risk of Death Due to Breast Implant-Associated Lymphoma?

 

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

 

On August 23, 2017, the Aesthetic Surgery Journal distributed a press release concerning a recent study on the risk of death from Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).

To provide some background information, BIA-ALCL is a rare non-Hodgkin lymphoma of T-cell origin that is typically found in the effusion fluid (seroma) surrounding the breast implant, or contained within the fibrous scar capsule.  While it is extremely rare, the consequences can be fatal if left untreated.  

Over the past few months, BIA-ALCL has been a source of concern due to the increased attention it has been receiving in the medical literature.

However, some medical professionals believe that false information regarding the risk of death due to BIA-ALCL is being spread.  One such doctor is William P. Adams, Jr. MD, the co-author of a recent study titled, "What’s Your Micromort? A Patient-Oriented Analysis of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)."  He explains his position in the following quote:

Unfortunately, patients are getting the wrong information, and this study is critical to correcting that.  Furthermore, with this data, we are now confident that this condition needs a reclassification as a lymphoproliferative disorder and not a lymphoma. We conducted this micromort study to bring real life perspective for all existing and potential  breast augmentation patients who might have reservations about implants based on the recent media coverage indicating that breast implants can be fatal - a sensationalized take on a very rare and very treatable condition.

Otherwise put, Dr. Adams does not believe that the risk of death due to BIA-ALCL is significant enough to warrant its current classification as a lymphoma.  

The measurement of a "micromort" is used to calculate this risk, and one micromort is equivalent to a one in one million chance of death.  The risk of death due to BIA-ALCL was estimated to be 0.4 micromorts.

To put this into perspective, the study provides the following comparisons:

• The micromort of a woman skiing for 1 day = 0.77, 2x that of a patient having a breast implant for life
• Drinking 2 glasses of wine or riding a bike for 17 miles = 1, 2.5x the micromort of having a breast implant for life
• Driving a car for 8 hours = 16, 40x the micromort of having a breast implant for life

Contrary to what one might believe, the authors of the study claim that its purpose was to accurately explain the risk of BIA-ALCL, not to downplay it.

Though few women are diagnosed with BIA-ALCL, and even fewer lose their lives as a result, many women still experience significant adverse effects that can be financially, emotionally, and physically costly.

If you or someone you know have been diagnosed with BIA-ALCL, we encourage you to visit our website for more information, and complete a free case evaluation.

We will continue to monitor the medical literature concerning breast implants and this rare type of lymphoma, and report on new information as it becomes available.

 

Breast Implants: Lymphoma / Blood Cancer Cases Overview

Free Breast Implants Case Evaluation

  

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Previous articles on this topic:

• Breast Implants and Lymphoma: Who's to Blame?
• Breast Implant Lymphoma: Causes Uncertain, but Costs Undeniable
• Breast Implants Linked to Rare Lymphoma Blood Cancer

 

FDA Warns of New Possible Side Effects for Nexium / Prilosec / Prevacid

 

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

 

The most recent report from the FDA Adverse Event Reporting System (FAERS) for April - June 2017 provides updates on adverse events experienced by those taking proton pump inhibitors (PPIs) such as Nexium, Prilosec, and Prevacid.

The FDA provides the following list of PPIs:

• Nexium (esomeprazole magnesium)
• Nexium I.V. (esomeprazole sodium)
• Prevacid (lansoprazole)
• Prevacid Solutab (lansoprazole) 
• Prilosec (omeprazole) 
• Aciphex (rabeprazole sodium)
• Esomeprazole strontium delayed-release capsules
• Protonix (pantoprazole sodium)
• Protonix (pantoprazole sodium) 
• Protonix IV (pantoprazole sodium) 

These PPIs have been associated with an increased risk of several adverse side effects such as chronic kidney disease (CKD) and acute kidney injury (AKI).  A Medscape article from earlier this year provides more information on this association. 

Despite the medical information available at present, the FDA does not deem it necessary to include warnings for such events on the labels for these drugs.

However, the FDA is currently investigating the relationship between PPI use and an increased risk in developing polyps in the stomach and duodenum (located in the small intestine).

At first, such a side effect may appear insignificant given that most polyps in these areas of the body do not become cancerous.

Additional research would reveal more cause for alarm, though, as certain types of stomach polyps can increase your risk of stomach cancer in the future according to the Mayo Clinic.

Furthermore, Cancer.org provides information on how a seemingly benign polyp in the duodenum could potentially lead to a major type of small intestinal cancer called adenocarcinoma:

Adenocarcinomas make up about 30% to 40% of small intestine cancers. This type of cancer starts from the cells that line the intestine. Most experts think that cancer of the small intestine develops much like colorectal cancer. It first begins as a small benign outgrowth called a polyp. Over time, the polyp can change into a cancer. Most small intestinal cancers develop in the duodenum and the rest occur in the jejunum and ileum.

It is important to realize that such scenarios represent the worst possible outcomes, and are not extremely likely.  As such, patients should discuss any concerns they have with their medical doctor before stopping a medication.

We are currently investigating drug injury cases on behalf of those who have used Nexium / Prilosec / Prevacid and been diagnosed with one of the following side effects:

• Acute Interstitial Nephritis (AIN)
• Chronic Kidney Disease (CKD)
• End-Stage Renal Disease (ESRD)
• Severe Renal Impairment
• Kidney / Renal Failure
• Acute Kidney Injury

For more information on PPIs and their potential side effects, we encourage you to visit our website and complete a free case evaluation form.

 

Drug Injury Watch: Side Effects News & Reports

Drug Injury Law: Medical & Legal Information

J&J Tries to Expand Invokana Label to Include Cardiovascular Benefits

 

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

 

Johnson & Johnson's, the drug manufacturer of diabetes drugs Invokana, Invokamet, and Invokamet XR, recently submitted a supplemental new drug application (sNDA) to the FDA to request expansion of the labels for these drugs.

If granted, the new label would include a cardiovascular indication concerning the reduction of risk of cardiovascular events in type 2 diabetes patients who have established CV disease or are at risk for CV disease.

The results of several recent studies on Invokana, called CANVAS and CANVAS-R, served as the catalysts for J&J's request.  These studies showed that patients who used Invokana / Invokamet / Invokamet XR--compared to those taking a placebo--were less likely to experience the following major cardiovascular events (MACE):

• Cardiovascular death
• Nonfatal myocardial infarctions (MI) / Heart attacks
• Strokes

However, these studies also brought to light a serious side effect of Invokana that has recently gained more attention in the medical literature. 

In July of this year, the risk of amputations--particularly of the lower limbs--was included in a black box warning on the drug label for Invokana, Invokamet, and Invokamet XR.  Black box warnings are the highest level of required warning for drugs manufactured and sold in the U.S., which illustrates just how severe this potential side effect is. 

To read more about this increased warning, see my latest article on the topic, "Could Invokana have been the cause of my lower-limb amputation?"

Going forward, it will be interesting to see whether the cardiovascular benefits of Invokana, Invokamet, and Invokamet XR will make up for any decrease in prescriptions due to the serious amputation side effects of these drugs.

We are currently investigating possible drug injury lawsuits against the responsible pharmaceutical companies for those who have undergone amputations of the lower limbs while using Invokana or other type 2 diabetes drugs.  We encourage you to complete a free case evaluation, and visit our website for more information on these drugs and their potential side effects.

 

Drug Injury Watch: Side Effects News & Reports

Drug Injury Law: Medical & Legal Information

 

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Previous articles on this topic:

• Could Invokana have been the cause of my lower-limb amputation?
• Can SGLT-2 Inhibitor Diabetes Drugs Increase Your Risk of Stroke?
• Invokana Shown to Have Heart Benefits, but Elevated Amputation Risks
• Risk of Lower Limb Amputations Doubled with Invokana and Invokamet Use
• All SGLT2 Inhibitors Now Investigated for Increased Risk of Amputation
• Are Invokana & Invokamet Linked to Increased Risk of Toe Amputations?

 

 

 

FDA Makes Adverse Drug Reactions Easier to Find with New Search Tool

 

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

 

On September 28, 2017, the FDA released a new search tool that allows patients, doctors, and others to see the adverse events reported for a particular drug or medical device by searching the product name, patient age, adverse event type and date, or timeframe in which an event occurred.

This tool is referred to as the FDA Adverse Events Reporting System (FAERS) Public Dashboard.

Information not provided by this new search tool includes individual case report narratives.  However, these narratives may be accessed through a Freedom of Information Act (FOIA) request.

FDA Commissioner Scott Gottlieb, M.D. describes the motivation for creating such a tool in the September 28, 2017 press release:

Tools like the FDA Adverse Event Reporting System are critical to the FDA’s ability to help ensure the greatest level of transparency and help patients and providers make safe use of drug and biologic products after they are approved by the FDA...The FDA is committed to fully informing patients and providers of adverse events reported with medical products and this enhanced portal now provides patients, doctors and others with easier access to the data they are interested in.

The FDA also hopes that this new tool will prompt the submission of more detailed and complete reports of adverse events by fostering a better understanding of the reported data.

While this tool will undoubtedly be helpful for patients who want to learn more information about the drugs they are prescribed, the FDA is careful to provide the following disclaimer:

While the FAERS dashboard now offers stakeholders many more ways of searching for and organizing data on adverse events reported to the FDA for many drug and biologic products, there remain limitations to the data. For example, while FAERS contains reports on adverse events associated with a particular drug or biologic, this does not mean that the drug or biologic caused the adverse event. Importantly, the FAERS data by themselves are not an indicator of the safety profile of the drug or biologic. Patients should still talk to their health care professional if they have any concerns regarding their medications.

Another limitation of the new search tool is the potential for duplicate, incomplete, or inaccurate reports.  

Regardless, this new searchable dashboard makes important information more accessible, and will most likely help many patients make more informed decisions when it comes to their healthcare.

From a drug injury law standpoint, this tool also may prove to be a valuable resource for patients who believe that a drug may have caused significant harm to their health, or the health of someone they know--even though the FDA is careful to point out that such reports do not indicate causation.

If you or someone you know has suffered an adverse effect due to a brand-name prescription drug, we encourage you to submit a Drug Injury Law Case Review –  it is free, confidential, and there is no obligation. 

 

Drug Injury Watch: Side Effects News & Reports

Drug Injury Law: Medical & Legal Information