Drug Safety Developments

New Study Suggests Erectile Dysfunction Drugs May Not Cause Melanoma

 

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

 

A recent study found in the Journal of the National Cancer Institute assessed the relationship between melanoma skin cancer and erectile dysfunction (ED) drugs like Viagra, Cialis, and Levitra.  Contrary to prior studies on this subject, they suggested that there may not be a link after all.

This new study conducted a review of previous studies that suggested ED drugs--also referred to as Phosphodiesterase inhibitors (PDE5i)--were associated with an increased risk for melanoma development.

They argued that the prior studies failed to identify certain confounding factors such as sun exposure, lifestyle factors, and socioeconomic status.  They expound on these notions, below:

Notably, both PDE5i use and skin cancer are strongly associated with socioeconomic status, suggesting potential for confounding by lifestyle factors. The increased risk of in situ melanoma among PDE5i users and reduction in advanced disease also raises the possibility of detection bias.

A Medscape article provides further explanation, saying, "the group of patients likely to take medicines for ED also happens to be more health conscious, more likely to see a physician, and so more likely to be diagnosed with melanoma than other men of similar age."

Here are the findings of this most recent study:

• Only low PDE5i exposure was associated with increased risk (RR = 1.15, 95% CI = 1.01 to 1.31), whereas high exposure was not (RR = 1.09, 95% CI = 0.97 to 1.23).
• High PDE5i exposure was associated with an increased risk of stage 0 melanoma (RR = 1.45, 95% CI = 1.09 to 1.92), but decreased risk of stage II to IV melanoma (RR = 0.67, 95% CI = 0.46 to 0.97).
• The risk for melanoma was increased by 11%, at a relative risk (RR) of 1.11, compared to those who did not use PDE5 inhibitors.

While the researchers state that "Our meta-analysis of four observational studies on PDE5i and melanoma found a statistically significant association," they are quick to point out that "it did not meet five of Hill’s nine causal criteria, suggesting against a causal relationship."

A summary of the implications of these findings is provided by the following Science Daily article:

The researchers found an overall increase in melanoma risk among men who used PDE5 inhibitors, but they hypothesized that if a cause and effect exists, higher use of erection medications would be associated with higher risk of developing the disease. Loeb and her colleagues found the opposite: there was an increase in risk among men who had a small amount of exposure to these medications, and men who took larger amounts of erectile dysfunction medications had no significant increase in melanoma risk.

Essentially, the researchers of this most recent study argue that "Overall, Viagra (sildenafil, Pfizer Inc) and other PDE inhibitors are safe medications as long as men are not taking nitrates, which carry a risk of reducing blood pressure."

However, we will continue to monitor the medical literature for updates concerning PDE5 inhibitors and an increased risk of melanoma skin cancer.

In the meantime, we encourage you to visit our website to learn more, and complete a free case evaluation if you or someone you know has been diagnosed with melanoma after using Viagra, Cialis, or Levitra.

 

Drug Injury Watch: Side Effects News & Reports

Drug Injury Law: Medical & Legal Information

 

Risk of Lower Limb Amputations Doubled with Invokana and Invokamet Use

 

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

 

As of yesterday, May 16, 2017, the FDA issued a Drug Safety Communication regarding an increased risk of leg and foot amputations due to use of popular diabetes drugs Invokana, Invokamet, and Invokamet XR, which contain canagliflozin.  

These drugs belong to the sodium glucose cotransporter 2 (SGLT2) inhibitor class, and are the subjects of the Canagliflozin Cardiovascular Assessment Study (CANVAS) and CANVAS-R (a study of the effects of canagliflozin on renal endpoints in adult participants with Type 2 diabetes mellitus).

We have been monitoring the medical literature concerning the risk of lower-limb amputations and drugs in the SGLT2 inhibitors class, such as canagliflozin (Invokana / Invokamet), empagliflozin (Jardiance / Glyxambi / Synjardy), and dapagliflozin (Farxiga / Xigduo / Qtern). 

The timeline below provides detailed information concerning previous warnings involving these drugs:

April 2016	The European Medicines Agency (EMA) warned that Invokana and Invokamet were linked to an increased risk of amputations, especially of the toes.
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May 2016	The FDA issued a Drug Safety Communication with the same warning for Invokana and Invokamet, but stated, "We have not determined whether canagliflozin increases the risk of leg and foot amputations. We are currently investigating this new safety issue and will update the public when we have more information."
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July 2016	The EMA stated that the Pharmacovigilance Risk Assessment Committee (PRAC) will now review all drugs in the SGLT2 inhibitors class in order to determine whether the increased risk of lower-limb amputations is possible for more than just Invokana and Invokamet.
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Feb. 2017	The EMA stated that warnings of amputations "should be included in the prescribing information for these medicines" in the SGLT2 inhibitor class.

 

The latest warning states the following:

Based on new data from two large clinical trials, the U.S. Food and Drug Administration (FDA) has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. We are requiring new warnings, including our most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk.

Adding this boxed warning, commonly referred to as a "black-box warning," is significant given that such warnings are designed to call attention to serious or life-threatening risks that are common enough to warrant the most prominent and serious warning a drug can have.

The FDA goes on to describe the results of the CANVAS and CANVAS-R studies of the effects of canagliflozin:

Final results from two clinical trials – the CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus) – showed that leg and foot amputations occurred about twice as often in patients treated with canagliflozin compared to patients treated with placebo, which is an inactive treatment. The CANVAS trial showed that over a year’s time, the risk of amputation for patients in the trial were equivalent to:

• 5.9 out of every 1,000 patients treated with canagliflozin
• 2.8 out of every 1,000 patients treated with placebo

The CANVAS-R trial showed that over a year’s time, the risk of amputation for patients in the trial were equivalent to:

• 7.5 out of every 1,000 patients treated with canagliflozin
• 4.2 out of every 1,000 patients treated with placebo

These studies show an approximate doubling of the risk for lower-limb amputations among patients who used diabetes drugs containing canagliflozin in comparison to those who received a placebo.

We will continue to monitor the medical literature concerning the risk of lower-limb amputations when taking Invokana, Invokamet (XR), and all other drugs in the SGLT2 inhibitors class of drugs.

In the meantime, we invite you to visit our Invokana / Invokamet / Farxiga / Jardiance information page, and complete our free case evaluation if you or someone you know have had to undergo a lower-limb amputation -- or have had a different severe side effect -- after using a SGLT2 inhibitor.

 

Drug Injury Watch: Side Effects News & Reports

Drug Injury Law: Medical & Legal Information

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More Articles on this topic:

• EMA Warns that Some Diabetes Drugs Cause Increased Risk of Amputation
• All SGLT2 Inhibitors Now Investigated for Increased Risk of Amputation
• Are Invokana & Invokamet Linked to Increased Risk of Toe Amputations?

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Breast Implants and Lymphoma: Who's to Blame?

 

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

 

As previously discussed in my articles, "Breast Implants Linked to Rare Lymphoma Blood Cancer" and "Breast Implant Lymphoma: Causes Uncertain, but Costs Undeniable, the FDA recently updated their 2011 report of the association between breast implants and anaplastic large-cell lymphoma (ALCL), providing additional information on this rare form of cancer that has affected over 359 women around the world.

A New York Times article recently relayed the stories of several women who were diagnosed with BIA-ALCL, the current statistics in the U.S. and abroad, as well as possible theories for how BIA-ALCL may develop in women who have had breast implants, particularly textured ones.

The article provides the following information on the theories with input from Dr. Mark W. Clemens II, a plastic surgeon and an expert on the disease at the University of Texas MD Anderson Cancer Center in Houston:

What exactly causes the disease is not known. One theory is that bacteria may cling to textured implants and form a coating called a biofilm that stirs up the immune system and causes persistent inflammation, which may eventually lead to lymphoma. The idea is medically plausible, because other types of lymphoma stem from certain chronic infections. Professional societies for plastic surgeons recommend special techniques to avoid contamination in the operating room when implants are inserted.

“It could also just be the immune system response to some component of the texturing,” Dr. Clemens said. The rough surface may be irritating or abrasive. Allergan implants seem to be associated with more cases than other types, possibly because they are more deeply textured and have more surface area for bacteria to stick to, he said.

A Medical Xpress article confirms the former theory, stating,

We knew that growth of bacteria on the surface of breast implants can, over time, cause an increase in stimulation of the lymphocytes, turning them into BIA-ALCL. However, we now know textured implants, which have a higher surface area, carry a significantly higher risk of BIA-ALCL. This is because these high surface area textured implants act as a passive conduit for the growth and proliferation of bacteria.

They also reference Allergan implants, and point out that 58.7% of BIA-ALCL cases involve Allergan Biocell salt loss textured implants.

An article by 9News provides additional information on this theory:

9NEWS understands clusters of cases of women who have developed ALCL after being operated on by the same surgeon have been reported.

The cancer is believed to develop from bacteria getting onto an implant before it’s inserted into a patient’s chest. Typically, it grows in a capsule of fluid around the implant and is diagnosed on average 7.5 years after surgery – although it can take decades. 

Additionally, this article mentions that Professor Anand Deva, head of cosmetic, plastic and reconstructive surgery at Macquarie University in Sydney, and his research colleagues have developed a "14-point plan for surgeons to prevent ALCL."

From a legal standpoint, this development is of particular interest, and raises some important questions.  Who should be held responsible for the suffering that results from hundreds of BIA-ALCL diagnoses?

If bacterial contamination of the breast implants prior to insertion is the cause of BIA-ALCL, can the blame be placed on the manufacturers of the breast implants?  The facilities in which the implant procedures are performed? The surgeons themselves? Do all parties share in the responsibility?

We will continue to monitor the medical literature concerning the association of breast implants with BIA-ALCL to look for new developments and better determine who should be held accountable for the harm that has befallen women who have received this diagnosis.

In the meantime, we invite you to visit the information page on our website if you would like to learn more about BIA-ACL, or complete our free case evaluation form if you or someone you know has been diagnosed with BIA-ALCL as a result of breast implants.

 

Breast Implants: Lymphoma / Blood Cancer Cases Overview

Free Breast Implants Case Evaluation

 

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Previous articles on this topic:

• Breast Implant Lymphoma: Causes Uncertain, but Costs Undeniable
• Breast Implants Linked to Rare Lymphoma Blood Cancer