Drug Injury Watch

Picato Skin Cancer Risk Findings Are Confirmed By European Drug Safety Panel In April 2020

FDA Investigation Of This Picato Drug Safety Issue Seems To Be Still Ongoing, Despite Picato Recall In Europe

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

A European drug safety panel announced in April 2020 that Picato increased risk of skin cancer findings outweigh Picato's benefits as a treatment of actinic keratosis. On January 27, 2020 we posted this article, "Picato Skin Cancer Risk Investigation By European Drug Regulator Prompts Sales Suspension In Europe", which provides some background for this Picato drug safety issue.

As regards this new development, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) noted a higher occurrence of skin cancers in areas treated with Picato (ingenol mebutate) than in areas of skin treated with another actinic keratosis treatment, imiquimod. It also noted that Picato’s benefit is not maintained over time and that other treatment options are available.

The Picato increased risk of skin cancer findings were further explained in this April 17, 2020 European Medicines Agency press release, "EMA review of Picato concludes medicine’s risks outweigh its benefits":

The conclusions are based on a review of all available data on the risk of skin cancer in patients using Picato, including results of a study comparing Picato with imiquimod (another medicine for actinic keratosis). The study showed a higher occurrence of skin cancers, especially squamous cell carcinoma, in areas of skin treated with Picato than in areas treated with imiquimod.

The [PRAC] also considered that Picato’s effectiveness is not maintained over time and noted that other treatment options are available for actinic keratosis....

Patients who have been treated with Picato should look out for unusual skin changes or growths, which may occur from weeks to months after use, and seek medical advice if any occur. Patients who have questions or concerns about their treatment should consult their doctor or pharmacist.  [emphasis added]

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As mentioned in our January 2020 article about this Picato skin cancer risk, at that point in time the FDA was gathering data and information to investigate this Picato drug safety issue.  Therein we referenced a Medscape news report, "European Marketing of Picato Suspended While Skin Cancer Risk Reviewed", published January 17, 2020:

"This matter does not affect Picato in the U.S., and there are no new developments in the [United States]. Picato continues to be available to patients in the U.S...." Rhonda Sciarra, associate director of global external communications for LEO Pharma, said in an email.

The FDA "is gathering data and information to investigate the safety concern related to Picato," a spokesperson for the FDA told Dermatology News. "We are committed to sharing relevant findings when we have sufficient understanding of the situation and of what actions should be taken," he added.

We will monitor the FDA Picato skin cancer risk investigation and report any significant drug regulatory actions on our Drug Injury Watch site.

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 is done by attorney Tom Lamb)

Belviq Recall: FDA Warning Cancer Risks Of Diet Drug Belviq Outweigh Benefits -- February 2020

Excess Cases Of Pancreatic Cancer, Colon Cancer, Rectal Cancer, And Lung Cancer Observed In Belviq Safety Clinical Trial

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

On February 13, 2020 the FDA requested Eisai Inc. to voluntarily withdraw its diet drug Belviq because a Belviq safety clinical trial shows an increased occurrence of cancer cases. The Belviq FDA Drug Safety Communication announcing this Belviq recall, "FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market", noted that excess cases of pancreatic cancer, colon cancer, rectal cancer, and lung cancer were observed.

For some background about the Belviq safety clinical trial showing the diet drug Belviq is associated with an increased occurrence of cancer cases see our January 14, 2020 article, "Belviq Cancer Risk Warning Alert Issued To Patients And Doctors In January 2020 FDA Drug Safety Communication".

The Data Summary section of this Belviq FDA Drug Safety Communication set forth these findings from the Belviq safety clinical trial:

There was a numerical imbalance in the number of patients with malignancies, with one additional cancer observed per 470 patients treated for one year. During the course of the trial, 462 (7.7 percent) patients treated with [Belviq (lorcaserin)] were diagnosed with 520 primary cancers compared to the placebo group, in which 423 (7.1 percent) patients were diagnosed with 470 cancers. Imbalances in specific cancers including pancreatic, colorectal, and lung contributed to the observed overall imbalance in cancer cases. There was no apparent difference in the incidence of cancer over the initial months of treatment, but the imbalance increased with longer duration on [Belviq (lorcaserin)].

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The FDA approved Belviq as a weight-loss drug in 2012.

The Belviq safety clinical trial leading to this February 2020 Belviq recall is the Cardiovascular and Metabolic Effects of Lorcaserin in Overweight and Obese Patients – Thrombolysis in Myocardial Infarction 61 (CAMELLIA-TIMI 61) clinical trial.

We are investigating possible Belviq lawsuits involving for patients who have been diagnosed with cancer, including but not limited to:

• Pancreatic Cancer
• Colorectal Cancer
• Colon Cancer
• Rectal Cancer
• Lung Cancer

For people with possible Belviq lawsuits -- personal injury or wrongful death -- we encourage them to submit a Belviq Case Evaluation Form.  It is free, confidential, and there is no obligation.

Of course, we will continue to monitor the medical research for more information about the specific types of cancer cases associated with Belviq.

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 is done by attorney Tom Lamb)

Picato Skin Cancer Risk Investigation By European Drug Regulator Prompts Sales Suspension In Europe

January 2020 News Report: FDA "is gathering data and information to investigate the safety concern related to Picato"

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

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UPDATE: The UK's Medicines and Health products Regulatory Agency (MHRA) issued a class 2 medicines recall for Picato on January 27, 2020.

Class 2 Medicines Recall: LEO Laboratories Ltd, Picato 150 mcg/g gel ▼, EU/1/12/796/001, Picato 500 mcg/g gel ▼, EU/1/12/796/002 (EL (20)A/02)

This regulatory action comes after the earlier voluntary sales suspension of Picato by LEO Pharma.

(1/28/2020)

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The topical gel drug Picato (ingenol mebutate) is prescribed for the treatment of actinic keratosis, or solar keratosis, a skin condition that can become cancerous in some patients. However, the safety of Picato is currently under scrutiny, as the European Medicines Agency (EMA) is investigating whether the use of Picato increases skin cancer risks.

From this January 17, 2020 press release, "EMA suspends Picato as a precaution while review of skin cancer risk continues", we get this information about the safety of Picato:

EMA is recommending that patients stop using Picato (ingenol mebutate), a gel for treating the skin condition actinic keratosis, while it continues its review of the medicine’s safety.

EMA’s safety committee [Pharmacovigilance Risk Assessment Committee (PRAC)] is currently reviewing data on skin cancer in patients using Picato. Final results from a study comparing Picato with imiquimod (another medicine for actinic keratosis) indicate a higher occurrence of skin cancer in the treatment area with Picato than with imiquimod.

While uncertainties remain, there is concern about a possible link between the use of Picato and the development of skin cancer. The PRAC has therefore recommended suspending the medicine’s marketing authorisation as a precaution and noted that alternative treatments are available.

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The company that markets Picato, LEO Pharma, issued a January 7, 2020 statement which sets forth its position on this new Picato drug safety issue:

The voluntary withdrawal [of Picato] is not linked to any new incidents of adverse events, customer complaints or quality effects....

LEO Pharma has carefully reviewed the information received from PRAC, and the company disagrees with the ongoing assessment of PRAC. There is no additional safety data and it is LEO Pharma’s position that there is no evidence of a causal relationship or plausible mechanism hypothesis between the use of Picato® and the development of skin malignancies.

A Medscape news report, "European Marketing of Picato Suspended While Skin Cancer Risk Reviewed", published January 17, 2020 let us know about the status of Picato in the US as that point in time:

"This matter does not affect Picato in the U.S., and there are no new developments in the [United States]. Picato continues to be available to patients in the U.S. We remain in dialogue with the U.S. Food and Drug Administration about Picato in the EU/EEA," Rhonda Sciarra, associate director of global external communications for LEO Pharma, said in an email. "We remain committed to ensuring patient safety, rigorous pharmacovigilance monitoring, and transparency," she added.

The FDA "is gathering data and information to investigate the safety concern related to Picato," a spokesperson for the FDA told Dermatology News. "We are committed to sharing relevant findings when we have sufficient understanding of the situation and of what actions should be taken," he added.

We will continue to monitor the safety of Picato and report any further drug regulatory actions here.

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 is done by attorney Tom Lamb)

Are Zantac NDMA Levels Increased By Heat Exposures During Shipping And Storage?

This Theory Would Explain Why NDMA Was Not Found To Be A Problem At Zantac Manufacturing Sites

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

The fact that Zantac contains NDMA (nitrosamine impurity called N-nitrosodimethylamine), a probable human carcinogen, was the subject of a September 13, 2019 FDA Press Announcement, "Statement alerting patients and health care professionals of NDMA found in samples of ranitidine".  Since then there has been uncertainty about how this Zantac NDMA problem went undetected for so many years. Ranitidine is the active ingredient in Zantac, which was initially approved by the FDA in 1983.

Several months later, there is a new theory about how that could have happened. From this January 2, 2020, Bloomberg news report, "Carcinogen in Heartburn Drug May Build in Storage, Lab Finds", we are presented with this possible scenario:

The heartburn medicine Zantac appears to produce unacceptably high levels of a cancer-causing chemical when exposed to heat for as little as five days, according to a testing laboratory....

New testing by an Alameda, California-based independent laboratory called Emery Pharma found that a combination of heat and time can raise levels of NDMA, potentially while drugs are sitting in packaging well after being analyzed by their manufacturers....

“The more you heat it, the more NDMA you generate,” Emery CEO Ron Najafi said in a telephone interview. “I am worried that if it just sits at home at room temperature, it could gradually generate NDMA.”

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That January 2020 news report, however, includes two points which may cause some people to view this new theory about the Zantac NDMA problem with some skepticism:

1.  Emery Pharma was hired by the pharmacy company Valisure LLC, which petitioned the FDA to recall all forms of Zantac; and,
2.  Emery CEO Najafi works as an expert witness in litigation alleging that Zantac contains NDMA.

So what comes next? The Bloomberg article provides this insight:

On [January 2, 2020], Emery filed a Citizen Petition with the FDA, asking the agency to suspend sales of all products containing ranitidine, to recall those that are already on the market and to require stability testing before they can be sold in the future. The medicine should also be shipped in temperature-controlled vehicles and carry warnings that potential cancer-causing byproducts may be produced if it is exposed to heat, the lab said.

As background, typically the FDA will review a filed Citizen Petition and eventually respond directly to the group that filed it.

So we will have to wait to see what the FDA thinks about this Zantac NDMA causation or mechanism of action theory developed by Emery Pharma.

Here is a related article we published previously: "Zantac FDA Warning In September 2019 Leads To Lawsuits For Patients Diagnosed With Cancer".

Our law firm is currently investigating possible Zantac cancer lawsuits for personal injury and wrongful death cases.

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 is done by attorney Tom Lamb)

Zantac FDA Warning In September 2019 Leads To Lawsuits For Patients Diagnosed With Cancer

Cases Involve Stomach, Colon, Rectal, Bladder, Kidney, And Pancreatic Cancers Diagnosed After Taking Zantac

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

Zantac cancer lawsuits are being filed for patients diagnosed with certain types of cancer after using Zantac (ranitidine) for heartburn associated with acid indigestion and sour stomach.

This is because Zantac contains NDMA (nitrosamine impurity called N-nitrosodimethylamine), a probable human carcinogen. This "new" fact was the subject of a September 13, 2019 FDA Press Announcement, "Statement alerting patients and health care professionals of NDMA found in samples of ranitidine".

Ranitidine is the active ingredient in Zantac -- both brand name prescription Zantac as well as over the counter, or OTC, Zantac which can be bought without a doctor's prescription at any pharmacy.

Since Zantac has been FDA-approved in the US for many years and used a countless number of times by millions of patients, this Zantac cancers FDA warning came as a shock for most of us.

According to medical research, some of the cancers associated with Zantac use due to NDMA exposure include:

• Stomach cancer
• Colon cancer
• Rectal cancer
• Bladder cancer
• Kidney cancer
• Pancreatic cancer

Since the September 2019 Zantac NDMA FDA announcement, some patients diagnosed with these cancers have contacted drug injury lawyers and, in turn, Zantac lawsuits have been filed against the pharmaceutical companies responsible for prescription Zantac and over the counter Zantac.

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As regards the medical research mentioned above, here are a couple of items:

1. A 2011 medical study looking at NDMA exposure concluded that NDMA ingestion, e.g., Zantac pills use, was significantly associated with an increased risk for gastrointestinal cancers including rectal cancer. See: Loh et al, "N-nitroso compounds and cancer incidence: the European Prospective Investigation into Cancer and Nutrition (EPIC)—Norfolk Study", 93 Am J CLIN NUTR. 1053-61 (2011).  [Full text of this article in PDF format]
2. A 2004 medical study concluded that the recent use of Zantac was also related to an increased risk of bladder cancer. See: Michaud et al, "Peptic ulcer disease and the risk of bladder cancer in a prospective study of male health professionals", 13 CANCER EPIDEMIOL BIOMARKERS PREV. 2, 250-254 (2004).  [Full text of this article in PDF format]

Our law firm is currently investigating possible Zantac cancer lawsuits for personal injury and wrongful death cases. Please feel free to contact us if you want help evaluating a Zantac case. This service is free, confidential, and there is no obligation.

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 is done by attorney Tom Lamb)

Pancreatic Cancer Associated With Use Of Diabetes Medicines In DPP-4 Inhibitor Drug Class

Increased Risk For Patients With Newly Diagnosed Type 2 Diabetes According To Recent Medical Research Study

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

Use of dipeptidyl peptidase-4 inhibitors (DPP-4i) diabetes medicines is associated with increased risks for pancreatic cancer in patients with newly diagnosed type 2 diabetes, according to an August 20, 2019 article published online by the Diabetes Care medical journal.

These diabetes medicines are in the dipeptidyl peptidase-4 (DPP-4) inhibitor drug class:

Onglyza (saxagliptin)
Kombiglyze XR (saxagliptin and metformin)
Qtern (dapagliflozin and saxagliptin)
Nesina (alogliptin)
Kazano (alogliptin and metformin)
Oseni (alogliptin and pioglitazone)
Tradjenta (linagliptin)
Jentadueto (linagliptin and metformin HCl)
Glyxambi (linagliptin and empagliflozin)

From an August 2019 Healio Endocrine Today news report, "DPP-IV inhibitors may increase risk for pancreatic cancer", we get some commentary from the medical researchers who conducted this drug safety study:

"DPP-IV inhibitors are widely used, well-tolerated antidiabetic agents that offer several advantages in clinical settings, especially for medically fragile populations, owing to their favorable efficacy and safety profile,” the researchers told Endocrine Today. “However, there is a concern that DPP-IV inhibitors may adversely impact the exocrine pancreas, owing to their pleiotropic effects. Thus, the pancreatic safety of incretin-based therapies is an important clinical issue to more safely prescribe this useful antidiabetic medication.”

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From the Abstract for this Diabetes Care article, "Nationwide Trends in Pancreatitis and Pancreatic Cancer Risk Among Patients With Newly Diagnosed Type 2 Diabetes Receiving Dipeptidyl Peptidase-4 Inhibitors", we get the following information:

• OBJECTIVE: Dipeptidyl peptidase-4 inhibitors (DPP-4i) are useful incretin-based antidiabetes drugs. However, there is a concern that DPP-4i may adversely impact the exocrine pancreas, owing to their pleiotropic effects. In this study, we investigated whether DPP-4i are associated with pancreatitis and pancreatic cancer using a nationwide population-based cohort study.
• RESULTS: Out of 33,208 subjects, 10,218 were new users of DPP-4i and 22,990 were new users of other antidiabetes drugs. DPP-4i significantly increased the risks of pancreatitis (adjusted hazard ratio [aHR] 1.24, 95% CI 1.01–1.52; P = 0.037) and pancreatic cancer (aHR 1.81, 95% CI 1.16–2.82; P = 0.009) with a 6-month drug use lag period. The risk of pancreatitis and pancreatic cancer was generally consistent in the first 12 months and 1 year after the initial prescription without showing an increasing trend according to exposure duration.
• CONCLUSIONS: DPP-4i use is associated with increased risks of pancreatitis and pancreatic cancer in patients with newly diagnosed type 2 diabetes. However, the absence of increasing trend according to exposure duration suggests the chances of reverse causality, and long-term pancreatic safety of DPP-4i has to be further investigated.

We will watch for additional medical research concerning the possible link between pancreatic cancer and DPP-4 inhibitor diabetes drugs such as Onglyza (saxagliptin), Nesina (alogliptin), and Tradjenta (linagliptin).

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 is done by attorney Tom Lamb)

 

Diabetes Drugs In DPP-4 Inhibitor Class Associated With Almost Two-Times Increased Risk Of Cholangiocarcinoma

Medical Researchers Finding This Rare But Highly Fatal Cancer Call For More Investigation Into New Possible Drug Side Effect

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

A recent medical study shows that the use of diabetes medicines in the dipeptidyl peptidase-4 (DPP-4) inhibitor drug class was associated with a near doubling of the risk of cholangiocarcinoma.

Diabetes drugs in the DPP-4 inhibitors class include the following:

• Januvia (sitagliptin)
• Janumet (sitagliptin / metformin HCl)
• Onglyza (saxagliptin)
• Kombiglyze XR (saxagliptin and metformin)
• Qtern (dapagliflozin and saxagliptin)
• Nesina (alogliptin)
• Kazano (alogliptin and metformin)
• Oseni (alogliptin and pioglitazone)
• Tradjenta (linagliptin)
• Jentadueto (linagliptin and metformin HCl)
• Glyxambi (empagliflozin / linagliptin)

 

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From this BMJ article, "Incretin based drugs and risk of cholangiocarcinoma among patients with type 2 diabetes: population based cohort study", published in December 2018 we get the following:

In this study, use of dipeptidyl peptidase-4 (DPP-4) inhibitors was associated with a near doubling of the risk for cholangiocarcinoma. The use of glucagon-like peptide-1 (GLP-1) receptor agonists was also associated with an increased hazard ratio of similar magnitude but generated a wide confidence interval that included the null value....

An association between incretin based drugs and incidence of cholangiocarcinoma is biologically plausible. One mechanism could involve the increased GLP-1 levels associated with use of both DPP-4 inhibitors and GLP-1 receptor agonists; GLP-1 might promote the development of cholangiocarcinoma through its proliferative and anti-apoptotic effects on cholangiocytes. Another mechanism could involve chronic inflammation of the biliary epithelium, bile stasis, and bacterial infections, which might be a particular concern with GLP-1 receptor agonists. These drugs have been associated with an increased risk of gallbladder related events (such as cholelithiasis, cholecystitis, cholangitis) in an observational study and in the LEADER trial. Finally, we observed increased hazard ratios in secondary analyses assessing possible duration-response relations with DPP-4 inhibitors. Specifically, the hazard ratio was particularly increased with cumulative durations ranging between one and two years of use and with more than two years since treatment initiation. Although these relatively rapid effects suggest that these drugs might act as tumour promoters among susceptible people, these secondary analyses were based on few events that generated wide confidence intervals and should thus be interpreted with caution.   [footnotes omitted]

The medical researcher who were the authors concluded this December 2018 BMJ medical journal article with an important call-to-action:

Given the high fatality rate of this cancer, post hoc analyses of randomised controlled trials and additional observational studies are needed to corroborate our findings.

We will continue to monitor the medical literature for more about cholangiocarcinoma being a possible side effect of DPP-4 inhibitor diabetes drugs.

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)

Four Distinct Diabetes Drugs MDL Cases: Byetta / Januvia / Victoza; Onglyza / Kombiglyze; Invokana; Farxiga

Current Number Of Drug Injury Lawsuits Filed In Each Of These Ongoing Federal Court MDL Cases: February 2018 JPML Report

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

At the present time there are four federal court Multidistrict Litigation (MDL) cases for drug injury lawsuits concerning several different types of diabetes medicines with unique sets of side effects.

From the February 15, 2018 version of this document, "MDL Statistics Report - Distribution of Pending MDL Dockets by Actions Pending" (accessed 2/21/18), published by the United States Judicial Panel on Multidistrict Litigation (JPML), we get the current number of cases filed in each of these diabetes drugs MDL cases.

We supplement that information provided by the JPML with the primary side effects that are the subject of personal injury lawsuits and wrongful death lawsuits filed in each of these diabetes drug MDL cases.

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IN RE: Incretin-Based Therapies Products Liability Litigation  MDL-2452

Number of lawsuits pending: 936

Diabetes drugs in this MDL case: 

• Byetta (exenatide)
• Bydureon (exenatide)
• Victoza (liraglutide)
• Januvia (sitagliptin)
• Janumet (sitagliptin)
• Janumet XR (sitagliptin)
• Juvisync (sitagliptin)

Primary side effect for these cases:

• Pancreatic Cancer, also known as Pancreas Cancer

Get more information about these drug injury cases and/or free case evaluation.

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IN RE: Invokana (Canagliflozin) Products Liability Litigation  MDL-2750

Number of lawsuits pending: 985

Diabetes drugs in this MDL case:

• Invokana (canagliflozin)
• Invokamet (canagliflozin and metformin)
• Invokamet XR (canagliflozin and metformin extended-release)

Primary side effects for these cases:

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

Get more information about these drug injury cases and/or free case evaluation.

 

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IN RE: Farxiga (Dapagliflozin) Products Liability Litigation  MDL-2776 

Number of lawsuits pending: 51
Diabetes drugs in this MDL case:

• Farxiga (dapagliflozin)
• Xigduo XR (dapagliflozin and metformin extended-release)
• Qtern (dapagliflozin and saxagliptin)

Primary side effects for these cases:

• Diabetic Ketoacidosis (DKA)
• Ketoacidosis
• Ketosis

Get more information about these drug injury cases and/or free case evaluation.

 

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IN RE: Onglyza (Saxagliptin) and Kombiglyze XR (Saxagliptin and Metformin) Products Liability Litigation  MDL-2809 

Number of lawsuits pending: 84
Diabetes drugs in this MDL case:

• Onglyza (saxagliptin)
• Kombiglyze XR (saxagliptin and metformin)

Primary side effect for these cases:

• Heart Failure

Get more information about these drug injury cases and/or a free case evaluation.

 

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We will continue to monitor the number of pending lawsuits in these four distinct diabetes drugs MDL cases and watch for significant developments in each of these federal court MDL litigations.

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) 

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) 

Association Of Melanoma With Viagra, Cialis, Other PDE-5 Drugs: Fall 2017 Review Of Recent Medical Articles

FDA Investigation Of Potential Link Between Melanoma Skin Cancer And ED Drugs As Well BPH And PAH Medicines Continues

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

From this FDA watch list of drugs with possible safety issues, "January - March 2016: Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS)", we learned that the US drug regulator is looking at the possible link between various drugs in the phosphodiesterase 5 (PDE-5) inhibitors class and melanoma as a side effect. The so-called "active ingredients" in the PDE5 class of drugs are sildenafil, tadalafil, vardenafil, and avanafil.

The five brand name erectile dysfunction (ED) drugs in the PDE-5 inhibitors class are Viagra (sildenafil), Cialis (tadalafil), Levitra (vardenafil), Staxyn (vardenafil), and Stendra (avanafil).

Cialis is also prescribed sometimes when doctors see the signs and symptoms of benign prostatic hyperplasia (BPH).

Two other PDE-5 inhibitors, Revatio (sildenafil) and Adcirca (tadalafil), are prescribed for the treatment of pulmonary arterial hypertension (PAH).

To date, there has not been any status update from the FDA on their investigation about this possible malignant melanoma side effect of the PDE-5 drugs.

But during 2017 thus far, there have been a few medical journal articles published regarding the safety issue of whether drugs like Viagra and Cialis might cause or promote skin cancer, especially melanoma, which can be fatal.

We start with "Relation of phosphodiesterase type 5 inhibitors and malignant melanoma: a meta-analysis and systematic review", which was published online back in April 2017 and, later, in the July 11, 2017 edition of the Oncotarget journal.

Here is the Abstract for this article, which sets forth the findings of some medical researchers in China:

Data on the association between using PDE5 inhibitors and malignant melanoma are conflicting. To estimate the relation of using PDE5 inhibitors with risk of malignant melanoma, Medline (Ovid) and Embase (Ovid) databases were searched up to February 2017, and a random effects model was used to calculate the summary risk estimates. Five observational studies were included. Five studies reports encompassed a total of 15,979 melanoma cases occurring among 1, 188,414 participants. The pooled multivariable-adjusted RR of melanoma in patients with using PDE5 inhibitors was 1.12 (95% CI: 1.03–1.21, I2 = 0.48). Findings from this systematic review support that PDE5 inhibitor use is associated with increased risk of melanoma in ED patients, the result remains inclusive and warrants further study in the future.

 

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Next is "Phosphodiesterase type 5 inhibitors and risk of melanoma: A meta-analysis", an article written by a set of five researchers affiliated with American and Chinese medical institutions. It was published by the Journal of the American Academy of Dermatology in September 2017.

Here are selected parts of the Abstract from this medical journal article:

• Background: The association between phosphodiesterase type 5 (PDE5) inhibitors and melanoma risk is controversial.
• Objective: We quantify the association between use of PDE5 inhibitors and melanoma.
• Results: Five observational studies were included. Compared with PDE5 inhibitor nonuse, PDE5 inhibitor use was slightly but significantly associated with an increased risk for development of melanoma (OR, 1.12; 95% CI, 1.03-1.21) and basal cell carcinoma (OR, 1.14; 95% CI, 1.09-1.19) but not squamous cell carcinoma. For melanoma risk, none of the prespecified factors (dose of PDE5 inhibitor, study design, and study region) significantly affected the results (P > .05). Our sensitivity analysis confirmed the stability of the results.
• Conclusions: Use of PDE5 inhibitors may be associated with a slightly increased risk for development of melanoma and basal cell carcinoma but not squamous cell carcinoma. However, further large well-conducted prospective studies with adequate adjustment for potential confounders are required for confirmation.

Last is this Review piece, "Update on the Safety of Phosphodiesterase Type 5 Inhibitors for the Treatment of Erectile Dysfunction", made available online by Sexual Medicine Reviews journal on October 12, 2017. It comes from two University of California researchers and one from University of Buenos Aires, in Argentina.

From this article's Abstract, here are two relevant points presented by these medical researchers:

1.   "There appears to be an association between [Phosphodiesterase type 5 inhibitors (PDE5Is)] use and melanoma but the absence of a mechanism of causation raises doubt that the association is cause and effect."; and,
2.   "Evidence on increased rates of melanoma and prostate cancer recurrence is weak and controversial."

Of course, we will continue to monitor the medical journals for additional research findings about malignant melanoma (perhaps more commonly called melanoma skin cancer) being linked to Viagra and Cialis as well as other PDE-5 drugs prescribed to treat erectile dysfunction (ED), benign prostatic hyperplasia (BPH), and pulmonary arterial hypertension (PAH).

And we look forward to eventually hearing from the FDA concerning their investigation of this drug safety issue.

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

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