Drug Injury Watch

Diet Drug Saxenda May Increase Pancreatic Cancer Risks For Patients Only Wanting Weight Loss

Saxenda Dose Contains Twice As Much Liraglutide As Diabetes Medicine Victoza, Also Linked To Malignancy In Pancreas

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

In 2014, the FDA approved Saxenda (liraglutide) for the treatment of obesity. Novo Nordisk is the responsible pharmaceutical company.

Liraglutide, the active ingredient for Saxenda, is a glucagonlike peptide-1 (GLP-1) receptor agonist. More generally, Saxenda is in the incretin mimetic class of drugs.

Four years earlier, the FDA approved another liraglutide-containing medicine, Victoza, which is a popular Type-2 diabetes drug.

Like Victoza, Saxenda has been associated with an increased risk of pancreatic cancer, or pancreas cancer, in patients using this still relatively new obesity, or weight-loss, drug.

However, the alarming difference between Saxenda and Victoza is that the standard dose of Saxenda for obesity contains 3.0 mg of liraglutide, while the standard doses of Victoza for diabetes are 1.2 mg or 1.8 mg of liraglutide. So the patient using Saxenda is getting about two-times more liraglutide than the patient using Victoza.

While the current Prescribing Information, or drug label, for Saxenda (accessed 1/30/18) has a so-called "Black-Box Warning" for the risk of thyroid C-cell tumors, a type of thyroid cancer, and pancreatitis is mentioned in the Warnings and Precautions section, there is nothing about an increased risk of pancreatic cancer.

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In this April 2015 news article, "After 13 years of wariness, FDA approves five potentially harmful new diet drugs", by medical reporters John Fauber, Coulter Jones and Kristina Fiore, the pancreatic cancer side effect of Saxenda and Victoza was examined:

Consider liraglutide, an injectable drug that works in part by helping the pancreas produce more insulin. The drug also suppresses appetite by fooling the brain into thinking the stomach is full.

Liraglutide is the generic name for Saxenda, which was approved for obesity in December. It is merely a higher dose of Victoza, a drug that has been marketed since 2010 for type 2 diabetes.

As a diabetes drug, Victoza was the primary suspect in 348 deaths and more than 3,100 hospitalizations through June 2014, according to the most recently available FDA data. At least 100 of those reported deaths were linked to pancreatic cancer....

With the approval of higher-dose Saxenda, the FDA doubled down on its confidence in the drug's safety. It has a 3-mg daily dose, compared with 1.2 mg or 1.8 mg for Victoza.

The labels for both drugs also warn patients to stop using the drugs promptly if pancreatitis is suspected.

That's what Tom LaRosa did last August when a blood test showed possible inflammation of his pancreas, said his wife, Sandy. The test was done because he had been having stomach problems, which can be a warning sign of pancreatic cancer.

LaRosa, 72, had been using the 1.8 mg dose of Victoza since 2010 to control his blood sugar with the hope it would also help him lose weight....

Despite stopping the use of Victoza in August, LaRosa's stomach problems got worse.

On Thanksgiving Day, the stomach pain was so severe that he went to the hospital. After a CT scan, he was diagnosed with pancreatic cancer.

He died in January.

Sandy LaRosa said her husband was never told that Victoza might increase his risk of pancreatic cancer. His doctor, Bradley Javorsky, MD, said he did tell LaRosa about the risks of pancreatitis and pancreatic cancer risk.

"I have that discussion with everybody," said Javorsky, an endocrinology and diabetes specialist and assistant professor with the Medical College of Wisconsin.

As stated above, today there is nothing about an increased risk of pancreatic cancer in the drug label for Saxenda, nor is there any such warning in the current Prescribing Information for Victoza (accessed 1/30/18).

While Dr. Javorsky may have talked with his patients about the pancreatic cancer risk of liraglutide back then, since there is no warning about pancreas cancer in either the current Saxenda or Victoza drug labels, it is unlikely that many doctors are having this discussion with their patients even today.

We are currently investigating pancreatic cancer cases involving Saxenda -- as well as Victoza and other incretin mimetic diabetes drugs such as Byetta, Bydureon, Januvia, and Janumet -- as drug injury lawsuits filed against the responsible pharmaceutical company based on this failure to warn about the increased risk of pancreatic cancer.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review done by attorney Tom Lamb) 

2018 Emerging Drug Litigations: Viberzi and Actemra

 

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

 

In 2017, Viberzi and Actemra were both identified as having significant adverse side effects.  In fact, many have even died as a result of conditions caused by these drugs.  

Looking forward into 2018, we will continue to monitor the medical and regulatory literature as well as conduct research concerning the harmful side effects of Viberzi and Actemra, and report on any significant developments.

 

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Viberzi

Viberzi (eluxadoline) is a relatively new drug used to treat irritable bowel syndrome in adults when the main symptom is diarrhea (IBS-D). 

It is usually taken daily in order to reduce diarrhea and abdominal pain, and acts directly in the intestine to decrease bowel contractions.

 

Potential Viberzi Side Effects

In March of 2017, the FDA issued a Drug Safety Communication regarding the potential side effects of Viberzi.  

The following medical conditions have been observed in patients who have had as few as one or two doses of Viberzi:

• Pancreatitis
• Acute Pancreatitis
• Hemorrhagic Pancreatitis
• Necrotizing Pancreatitis
• Sphincter of Oddi Spasm

While the FDA found that these conditions were more likely to occur among patients who did not have a gallbladder, these conditions were also observed in patients with a gallbladder.

 

Free Viberzi Case Evaluation

If you or some one you know used Viberzi and received a diagnosis of pancreatitis or Sphincter of Oddi spasm, then we encourage you to submit a Drug Injury Law Case Review – it is free, confidential, and there is no obligation.

 

Resources:

Most Recent Article: Viberzi - Pancreatitis Side Effects Can Develop At Any Time While Taking This IBS Drug, According To FDA Safety Warning

Information Page: Viberzi Side Effects

 

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Actemra

Actemra (tocilizumab) is an injection approved by the FDA for the treatment of several different medical conditions:

1.  Moderately to severely active rheumatoid arthritis in adult patients who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs);
2.  Giant Cell Arteritis (GCA) in adult patients;
3.  Polyarticular Juvenile Idiopathic Arthritis (PJIA) in patients 2 years of age and older; and,
4.  Systemic Juvenile Idiopathic Arthritis (SJIA) in patients 2 years of age and older.

 

Potential Actemra Side Effects

According to the FDA, the following side effects have been observed among those using Actemra:

• Pancreatitis
• Heart Failure
• Heart Attacks / Myocardial Infarction (MI)
• Strokes (CVA)
• Interstitial Lung Disease (ILD)

At this point in time, there seems to be a significant amount of evidence that Actemra may increase the risk of heart failure and pancreatitis.  However, the FDA is still in the process of reviewing the "less convincing" evidence that it causes heart attacks, strokes, and ILD. 

To date, they have yet to require these side effects to be added to the drug label.

 

Free Actemra Case Evaluation

If you or some one you know used Actemra and received a diagnosis of pancreatitis, heart failure, heart attack, stroke, or ILD, then we encourage you to submit a Drug Injury Law Case Review – it is free, confidential, and there is no obligation.

 

Resources:

Most Recent Article: Despite The High Number Of Actemra - Pancreatitis Cases Reported To FDA, No Warning Added To Drug Label

Information Page: Actemra Side Effects

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DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review done by attorney Tom Lamb) 

2018 Emerging Drug Litigations: Mirena IUD and Ocaliva

 

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

 

In 2017, the Mirena IUD and Ocaliva were both identified as having significant adverse side effects.  Mirena IUD lawsuits have already been filed, and several people have lost their lives as a result of Ocaliva. 

Looking forward into 2018, we will continue to monitor the medical and regulatory literature as well as conduct research concerning the harmful side effects of the Mirena IUD and Ocaliva, and report on any significant developments.

 

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Mirena IUD

Mirena is an intrauterine device (IUD) that releases small amounts of a progestin hormone called levonorgestrel. 

This hormone works to prevent pregnancy for up to five years through several processes that take place within the female reproductive system.

 

Potential Mirena IUD Side Effects

Apart from the more common Mirena IUD side effects such as migration of the device, perforation of the uterus, and embedment within the uterus, an additional harmful side effect was recently identified.

Pseudotumor cerebri (PTC), also referred to as idiopathic intracranial hypertension (IIH), is a condition that is caused by an accumulation of cerebrospinal fluid (CSF) in the skull. This excess of fluid creates pressure on the brain, which can lead to swollen optic nerves.

Unfortunately, the failure to timely diagnose and treat PTC / IIH may lead to permanent vision loss and even blindness. 

However, diagnosing this condition is not as straightforward as one would hope.  Patients experiencing the symptoms of PTC / IIH often first undergo an MRI, CT scan, and/or other diagnostic radiology tests to rule out an actual tumor or blood clot in the brain.  A lumbar puncture, or spinal tap, may then be performed in order to confirm the diagnosis of PTC / IIH.

The symptoms of PTC / IIH include:

• Severe migraines or migraine-like headaches with blurred vision
• Diplopia (double vision)
• Temporary blindness, blind spots, or other visual deficiencies
• Papilledema (optic disc swelling) due to increased intracranial pressure
• Tinnitus (a “whooshing” or ringing in the ear)

 

Free Mirena Case Evaluation

If you or some one you know used the Mirena IUD and received a diagnosis of PTC / IIH, or experienced the symptoms mentioned above, then we encourage you to submit a Drug Injury Law Case Review – it is free, confidential, and there is no obligation.

 

Resources:

Most Recent Article: Mirena IUD Associated with Harmful Neurological Side Effect

Information Page: Mirena IUD Side Effects

 

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Ocaliva

Ocaliva (obeticholic acid) was approved by the FDA in May 2016 for the treatment of primary biliary cholangitis (PBC).

It can be used in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.

 

Potential Ocaliva Side Effects

The FDA reported that many patients were receiving incorrect doses of Ocaliva, which was putting them at an increased risk of serious liver injury and even death.

More specifically, Ocaliva may lead to drug-induced liver injury / hepatitis, liver / hepatic failure, or hepatic necrosis.

The following symptoms may be signs of liver injury:

• New or worsening fatigue
• Diarrhea
• Weight loss
• Abdominal pain
• Decreased appetite
• Nausea and vomiting
• Change in behavior or confusion
• Vague symptoms such as anxiety or unease
• Abdominal swelling
• Yellow eyes or skin
• Bloody stools

  

Free Ocaliva Case Evaluation

If you or some one you know used Ocaliva and received a diagnosis of drug-induced liver injury, liver failure, or death, then we encourage you to submit a Drug Injury Law Case Review – it is free, confidential, and there is no obligation.

 

Resources:

Most Recent Article: Will Ocaliva Get Black-Box Warning For Liver Injury Side Effects After September 2017 FDA Report?

Information Page: Ocaliva Side Effects

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DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review done by attorney Tom Lamb) 

Drug-Induced Liver Injury Warning Added To OFEV Label In Canada As Done Earlier In US

This Relatively New Idiopathic Pulmonary Fibrosis (IPF) Pill Is Clearly On The Radar Of Drug Safety Regulators

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

OFEV (nintedanib) capsules were approved by the FDA in 2014 for treatment of idiopathic pulmonary fibrosis (IPF). Boehringer Ingelheim Pharmaceuticals, Inc. is the drug company responsible for OFEV in the US.

On January 11, 2018 Health Canada issued a Dear Healthcare Professional Letter communication titled "OFEV (nintedanib) - Risk of Drug-Induced Liver Injury and the Need for Regular Monitoring of Liver Function".

From the Background Information section of that new Health Canada document we get this overview of the safety issue:

OFEV (nintedanib) is used to treat idiopathic pulmonary fibrosis (IPF).

Cases of [drug-induced liver injury (DILI)] have been observed with OFEV treatment in the post-marketing setting since the product was launched in 2014. The overall cumulative [idiopathic pulmonary fibrosis (IPF)] patient exposure to OFEV from marketing experience is estimated to be over 32,000 patient-years. As of October 15, 2017, 32 cases of DILI have been reported worldwide in patients treated with OFEV, including one in Canada. In 24 of the 32 cases, the outcome of the DILI events was reported. In the majority (17) of these cases, the DILI event resolved when the dose was reduced or treatment was stopped. In 6 cases, the patient had not recovered at the time of reporting. One case resulted in fatal outcome.

That document went on to state "Health Canada is working with the manufacturer to update the Canadian Product Monograph [for OFEV] with this safety information."

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OFEV

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This forthcoming label change for OFEV in Canada follows similar regulatory action taken in the US several months ago, as indicated by an August 4, 2017 letter from the FDA to Boehringer Ingelheim Pharmaceuticals Inc.

As regards the OFEV - liver drug safety issue, the following text was added to the Warnings and Precautions part of the Full Prescribing Information for OFEV document (accessed 1/11/18) as a result of that August 2017 FDA letter: 

5.2 Elevated Liver Enzymes

Cases of drug-induced liver injury have been observed with OFEV treatment [see Adverse Reactions (6.2)]. In the post-marketing period, non-serious and serious cases of drug-induced liver injury, including severe liver injury with fatal outcome, have been reported. The majority of hepatic events occur within the first three months of treatment. In clinical trials, administration of OFEV was associated with elevations of liver enzymes (ALT, AST, ALKP, GGT) and bilirubin. Liver enzyme and bilirubin increases were reversible with dose modification or interruption in the majority of cases. The majority (94%) of patients with ALT and/or AST elevations had elevations <5 times ULN. The majority (95%) of patients with bilirubin elevations had elevations <2 times ULN [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. Patients with a low body weight (<65 kg), Asian, and female patients may have a higher risk of elevations in liver enzymes. Nintedanib exposure increased with patient age, which may also result in a higher risk of increased liver enzymes [see Clinical Pharmacology (12.3)]. Conduct liver function tests (ALT, AST, and bilirubin) upon initiation of treatment with OFEV, at regular intervals during the first three months of treatment, and periodically thereafter or as clinically indicated. Dosage modifications or interruption may be necessary for liver enzyme elevations. If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment with OFEV, promptly interrupt therapy [see Dosage and Administration (2.1, 2.3)].

We will continue monitor the medical literature, FDA, and Health Canada for further developments regarding this drug-induced liver injury issue for OLEV.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review done by attorney Tom Lamb) 

Drug Injury Watch: 2017 Collection Of Articles / Blog Posts

 

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

 

At the Law Offices of Thomas J. Lamb, we are committed to providing up-to-date information on matters pertaining to drug injury law.  Over the course of 2017, we have reviewed countless medical studies and journals, and reported the significant medical, legal, and regulatory developments through our two blogs.

Attorney Tom Lamb's blog, Drug Injury Watch, consists of articles related to serious side effects of prescription drugs, and major developments in some of the current drug litigations.

My blog, Drug Safety Developments, reports and elaborates on the information contained in medical and legal news concerning the safety of brand-name prescription drugs.

Below, I have provided an index of the articles published on the Drug Injury Watch blog in 2017.  These articles are organized categorically, and listed in the following section.  Click on the categories below to jump to that section of the page, then click on the title of the article to view it in full at its source.

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Categories:

• SGLT-2 Inhibitors Diabetes Drugs
• Hepatitis C Treatment Drugs
• Anticoagulants / Bloodthinners
• Breast Implants
• Osteoporosis Treatment Drugs
• Erectile Dysfunction (ED) Drugs
• Heartburn / Acid Reflux Drugs
• Multiple Sclerosis (MS) Treatment Drugs
• DPP-4 Inhibitors Diabetes Drugs
• Miscellaneous

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SGLT-2 Inhibitors Diabetes Drugs:

• Jardiance - Amputations Drug Safety Issue Remains Uncertain Due To Admitted "inherent limitations of... post hoc analyses" (11/28/17)
• Medical Researchers Continue To Study Bladder Cancer As A Possible Side Effect Of Jardiance (11/7/17)
• Invokana - Amputations Of Lower Limbs: A Drug Side Effect Which Needs Further Explanation As Regards "How" And "Why" (10/24/17)
• A "Dear Doctor" Letter For Invokana Amputations Side Effect Was Sent September 2017 By Janssen In Canada (9/7/17)
• Analysis Of FDA Adverse Event Reports Describes Extent And Nature of Invokamet / Invokana - Amputation Side Effect (8/10/17)
• Invokana - Amputation Side Effect Gets "Black-Box Warning" On Revised Drug Label Issued In July 2017 (7/27/17)
• Jardiance, Invokana, Farxiga, And The Other SGLT2 Inhibitors Might Double The Risk Of Diabetic Ketoacidosis (DKA) (6/8/17)
• Farxiga MDL Created In April 2017; Assigned to Federal Court Judge Lorna Schofield In New York (5/12/17)
• Federal Court Invokana MDL: Judge Martinotti Is Presiding Over These Drug Injury Lawsuits In New Jersey (3/14/17)
• Pending Motion Requests Multidistrict Litigation (MDL) For Farxiga And Xigduo XR Lawsuits Filed In Federal Court (3/8/17)
• Diabetes Medicine Invokana Gets New Warning About Lower Limb Amputation Added To Drug Package Insert In Canada (1/2/17)

 

Hepatitis C Treatment Drugs:

• Health Canada: There Is No Apparent Link Between Sovaldi Or Harvoni With Liver Cancer Recurrence As Of April 2017 (6/1/17)
• Harvoni / Sovaldi: Spring 2017 Update On Issue Of Liver Cancer Recurrence After Using Direct-Acting Antiviral "Hep-C" Drugs (4/27/17)
• February 2017 Label Changes For Sovaldi, Harvoni, And Other DAA Hepatitis C Drugs Are Made So As To Add A "Black-Box" Warning (2/16/17)
• New Safety Issue: Direct-Acting Antivirals Drugs For Hepatitis C Such As Harvoni And Sovaldi Could Cause Liver Failure (1/27/17)
• Is Liver Cancer Associated With Harvoni, Sovaldi, And Other Direct-Acting Antiviral Medications For Hepatitis C? (1/11/17)

 

Anticoagulants / Bloodthinners:

• Rate Of Gastrointestinal Bleeding Requiring Hospital Readmission Higher With Pradaxa Use Than Warfarin Use (10/4/17)
• New Medical Evidence Suggests Pradaxa And Xarelto May Double The Risk Of Heart Attacks In Atrial Fibrillation Patients (4/12/17)
• Pradaxa Lawsuits And Settlements: Past, Present, And Future Aspects Are Explained In This 2017 Update Report (3/21/17)
• February 2017: Eliquis MDL Established For Federal Court Lawsuits; Placed In Southern District Of New York, With Judge Cote Presiding (2/10/17)

 

Breast Implants:

• Breast Implant Associated Anaplastic Large-Cell Lymphoma (BIA-ALCL): New Medical Journal Article About Treatments (9/1/17)
• The Association Between Breast Implants And Anaplastic Large Cell Lymphoma (ALCL) Is Better Understood In Recent Years (4/20/17)
• The Rare Lymphoma (Blood Cancer) Linked To Breast Implants Causes Nine Patient Deaths (3/31/17)

 

Osteoporosis Treatment Drugs:

• Merck Wants The US Supreme Court To Reverse A Federal Appeals Ruling In Fosamax - Femur Fractures Litigation (9/18/17)
• Fosamax - Femur Fracture Lawsuits In Federal Court MDL: March 2017 Appellate Court Ruling Reinstates Lawsuits (3/24/17)

 

Erectile Dysfunction (ED) Drugs:

• Association Of Melanoma With Viagra, Cialis, Other PDE-5 Drugs: Fall 2017 Review Of Recent Medical Articles (10/31/17)
• August 2017 ED Drugs Label Change Warns That Some Users Of Cialis, Levitra, And Viagra Have Developed NAION Vision Loss (8/24/17)

 

Heartburn / Acid Reflux Drugs:

• Prilosec / Prevacid / Nexium Federal Court Lawsuits For Kidney Injury Consolidated By MDL Established In August 2017 (8/16/17)
• New "Silent" Side Effect of Prilosec And Nexium: Chronic Kidney Disease (CKD), Without Any Prior Acute Kidney Injury (2/23/17)

 

Multiple Sclerosis (MS) Treatment Drugs:

• New MS Drug Ocrevus Gets Possible Bad News About Side Effects Soon After Good News About Sales Projections (5/25/17)
• Multiple Sclerosis Drug Tecfidera: FDA Mandates January 2017 Label Change Which Adds Warnings About Liver Injury Cases (2/7/17)

 

DPP-4 Inhibitors Diabetes Drugs:

• Potential Safety Signal: Rhabdomyolysis May Be Linked To Onglyza, Nesina, Januvia, And Other Diabetes Drugs (10/11/17)

 

Miscellaneous:

• Gadolinium-Containing Contrast Agents Omniscan And Magnevist Being Recalled In The United Kingdom In February 2018 (12/19/17)
• FDA Recommends A Recall For Limbrel "Medical Food" Product But Primus Pharmaceuticals Is Not Complying (12/8/17)
• New Heart Failure Drug Entresto Apparently Has Safety Signal For Hypotension (Low Blood Pressure) Side Effect (11/21/17)
• Gout Medicine Uloric Safety Trial Shows Increased Risk Of Heart-Related Deaths According To November 2017 FDA Alert (11/15/17)
• Viberzi - Pancreatitis Side Effects Can Develop At Any Time While Taking This IBS Drug, According To FDA Safety Warning (10/18/17)
• Will Ocaliva Get Black-Box Warning For Liver Injury Side Effects After September 2017 FDA Report? (9/26/17)
• European Drug Regulator EMA Suspends Use Of MRI Drugs Magnevist, Omniscan, And OptiMARK In July 2017 (8/3/17)
• Keytruda, Opdivo, And Yervoy May Be Associated With Vision Loss And Retinal Detachment In Addition To Uveitis (7/13/17)
• Despite The High Number Of Actemra - Pancreatitis Cases Reported To FDA, No Warning Added To Drug Label (6/26/17)
• There Is Continuing Concern About Whether Victoza Is Associated With Pancreatic Cancer As A Possible Side Effect (6/19/17)
• May 2017 "Dear Doctor" Letter About Aranesp Cases Of Stevens-Johnson Syndrome (SJS) And Toxic Epidermal Necrolysis (TEN) (5/18/17)
• Growing Concern About Reports Of Children Who Developed Neuro-Psychiatric Problems After Taking MiraLAX (5/4/17)
• Iclusig: Leukemia Drug With Many Different Serious Side Effects Had More Warnings Added In November 2016 (1/19/17)

 

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We hope you continue to read Drug Injury Watch and Drug Safety Developments in 2018.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review done by attorney Tom Lamb)