Actemra Emerging Mass Tort Litigation Preliminary Adverse Event Reports
The following article addresses reports related to adverse events and medical conditions potentially related to the use of the Rheumatoid arthritis drug Actemra. The article will cover a report published by STAT which identified 5 major adverse events (AEs) and medical conditions (MCs) potentially caused by Actemra. We will also cover a larger number serious AEs and MCs potentially related to the use of Actemra identified by Mass Tort Nexus using our proprietary adverse event indicator algorithm.
The AEs and MCs identified by Stat as well as Mass Tort Nexus only include those arguably not warned of on the product label in the Unitied States.
The report from Stat was recently published in June 2017. The stat report linked Actemra to the following AEs and MCs:
- Heart Attack
- Heart Failure
- Interstitial Lung Disease
The Mass Tort Nexus (MTN) investigation has thus far identified the following AEs and MCs potentially linked to Actemra. It should be noted that the MTN report is based on a partially automated process in addition to traditional research as a result, the MTN investigation into any medical device or drug is essentially always ongoing. The following is MTNs list:
- Interstitial lung disease
- Myocardial infarction, Congestive Heart Failure and other Cardiac Disorders
- Acute Myelomonocytic Leukemia
- Bone marrow failure
- Increase in required knee replacements resulting from synovitis
- Demyelinating Disorders such as Multiple Sclerosis and Guillain-Barre syndrome
- Psoriatic arthritis
- Pancreatic cancer
The remainder of this article will briefly define the conditions (not commonly known) we have identified as being potentially caused by the use of Actemra as well as our reasoning for the inclusion of theses AEs and MCs on our current list.
Interstitial lung disease
Interstitial lung disease describes a wide range of disorders which result in progressive scarring of the tissues of the lungs. Common among all of these disorders is decreased profusion (inability to breathe).
Mass Tort Nexus included Interstitial lung disease in our findings primarily based on the extremely large number of adverse event reports which have been filed with the FDA as well as regulatory agencies in other countries.
It should be noted that Interstitial lung disease is a common co-morbidity factor in RA patients. Although early indications lead us to believe that the use of Actemra increases the risk of Interstitial lung disease above the baseline for RA patients in general, our research into this matter is ongoing.
Although it is unclear why Actemra users experience a higher death rate than RA patients using other therapies, there is a strong indication that death does in fact occur more frequently in the Acterma user group. This conclusion was based on adverse event reports which have been filed with the FDA as well as regulatory agencies in other countries as well as other factors.
Myocardial Infarction, Congestive Heart Failure and other Cardiac Disorders
The inclusion of MI, CHF and Cardiac Disorders in general was based in part on the drug manufacturers on Clinical Research used to gain FDA approval as well as case reports from sources world wide. This research is also supported by adverse event reporting data.
Acute Myelomonocytic Leukemia
Acute myelomonocytic leukemiais a form of acute myeloid leukemia that involves a proliferation of CFU-GM myeloblasts and monoblasts. Acute myeloblastic leukemia is a group of malignant bone marrow neoplasms of myeloid precursors of white blood cells.
The inclusion of Acute myelomonocytic leukemiais is based on adverse event report reviews and case reports as well as other published literature deemed reliable.
Synovitis and Increased Knee Replacements
Synovitis describes inflammation of the synovial membrane. This membrane lines joints cavities, known as synovial joints.
Our inclusion of Synovitis and Increased Knee Replacements on this list was a result of adverse event report reviews as well as other data that we believe demonstrates a correlation between the use of Actemra and Synovitis leading to an increased number of knee replacements.
Bone Marrow Failure
Bone marrow failure occurs in individuals who produce an insufficient number of red blood cells, white blood cells or platelets.
Our inclusion of Bone Marrow Failure on this list is based on our adverse event report reviews as well as other indicators. Our inclusion on this list is also based on the significance of the disorder itself. Bone Marrow Failure can lead to a vast number of secondary conditions, may of which are fatal. If further research demonstrates that Actemra causes bone marrow failure (not simply is correlated to bone marrow failure), the significance for existing Actemra users as well as future potential Actemra users could actually be life or death.
Psoriasis and Psoriatic arthritis
It is worth noting that other drugs such as Humira, also approved to treat RA are additionally approved for the treatment of Psoriasis. In the case of Actemra, there is some indication from case studies, adverse event report reviews as well as published articles from authoritative sources that Actemra may increase the risk of developing psoriasis. This may explain why Roche has not sought approval (as is the case with many RA drugs) for the treatment of Psoriasis given that the market for Psoriasis treatments is exponentially larger than the market for RA treatments.
The inclusion of Psoriatic arthritis on our list is based solely on the well established fact that a significant percentage of patients that develop Psoriasis will eventually develop Psoriatic arthritis as a secondary condition.
Demyelinating Disorders such as Multiple Sclerosis and Guillain-Barre syndrome
Demyelinating disorders include any condition that results in damage to the protective covering (myelin sheath) that surrounds nerve fibers in your brain and spinal cord. Damage to the myelin sheath results in the slowing of nerve impulses and can lead to a number of neurological problems.
Our inclusion of Demyelinating Disorders is based on a Dear Health Care Provider Letter sent to health care providers in 2013, warning of several conditions potentially related to or caused by the use of Actemra. All but two of these conditions have been added to the Actemra Label with the exclusion of Demyelinating Disorders and malignancies. Indications from our review of adverse event reports also justifies Demyelinating Disorders inclusion in this list.
A malignancy is simply the presences of a cancerous tumor.
Our reason for inclusion of Malignancies in this list is in part based on the Dear Health Care Provider Letter referenced above for the same reasons we included Demyelinating Disorders. There is also support for AEs related to Cancer and Actemra in the review of adverse events, case reports and other reliable literature.
Pancreatitis and Pancreatic Cancer
Our inclusion of Pancreatitis in this list is based on a review of adverse event reports, case reports as well as literature from sources deemed to be reliable.
Our inclusion of pancreatic cancer in this list is based on the well established fact that patients that suffer from Pancreatitis are at an increased risk for pancreatic cancer. Although the number of patients that develop pancreatic cancer secondary to pancreatitis is relatively small, the fact that pancreatic cancer is generally fatal, we feel its inclusion on this list is warranted.
Correlation vs Causation
It is important to note that neither the Stat Report nor the information reported in this article are sufficient to indicate that Actemra causes any of the AEs or MCs listed. The report and this article observe correlations. Discovering correlation is a necessary step towards determining causation however, correlation alone does not prove causation.
Even if Actemra does cause every AE and MC listed in the Stat Report and this article, the evidence to prove this causation may never come into existence. The drug maker has little incentive to fund clinical studies to prove their product causes an adverse event. Developing proof of causation for any AE or MC is largely dependent unintended outcomes of studies the drug maker may still have motive to publish or information developed by the FDA or FDA equivalents in other countries.
In our opinion, to date, the strongest causation evidence exists for the following AEs and MCs:
Heart Disorders, including Congestive Heart Failure and Myocardial Infarction.
As our investigations continue, we are highly likely to find additional evidence related to the AEs and MCs listed as well as others. We expect to be publishing information related to Actemra for the next several years.